A Study to Evaluate the Safety and Efficacy of Gocatamig (MK-6070) and Ifinatamab Deruxtecan (I-DXd) in Participants With Relapsed/Refractory Extensive-Stage Small Cell Lung Cancer (MK-6070-002)

April 17, 2026 updated by: Merck Sharp & Dohme LLC

A Phase 1b/2 Open-Label Clinical Study to Evaluate the Safety and Efficacy of MK-6070 and Ifinatamab Deruxtecan (I-DXd) in Participants With Relapsed/Refractory Extensive-Stage Small Cell Lung Cancer

Researchers are looking for new ways to treat people with extensive-stage small cell lung cancer (SCLC) that has relapsed or is refractory. Gocatamig is a new type of immunotherapy that uses a person's immune system to find and destroy cancer cells. Ifinatamab deruxtecan (also known as I-DXd) is a drug which binds to a specific target on cancer cells and delivers treatment to destroy those cells. Durvalumab is a different type of immunotherapy that also destroys cancer cells. Researchers want to know if giving gocatamig, I-DXd, and gocatamig with I-DXd or durvalumab can treat SCLC that did not respond or stopped responding to a prior treatment.

The goals of this study are to learn:

  • If gocatamig alone, I-DXd alone, and gocatamig with I-DXd or durvalumab are safe and well tolerated
  • If people who receive gocatamig alone, I-DXd alone, and gocatamig with I-DXd or durvalumab have their SCLC get smaller or go away

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

This study will consist of two parts. Part 1 will assess the safety, tolerability, and efficacy of gocatamig and I-DXd at doses determined in study MK-6070-001 (NCT: NCT04471727). Part 2 will assess the safety and tolerability of gocatamig in participants in Japan and China. Part 3 will assess the safety, tolerability, and efficacy of gocatamig with durvalumab.

Study Type

Interventional

Enrollment (Estimated)

262

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Argentina
    • Buenos Aires
      • Pilar, Buenos Aires, Argentina, B1629WWA
        • Recruiting
        • Hospital Universitario Austral ( Site 2204)
        • Contact:
          • Study Coordinator
          • Phone Number: 02304482000
    • Santa Fe Province
      • Rosario, Santa Fe Province, Argentina, S2000DSV
        • Recruiting
        • Sanatorio Parque ( Site 2203)
        • Contact:
          • Study Coordinator
          • Phone Number: +5493416955611
  • Australia
    • Queensland
      • Woolloongabba, Queensland, Australia, 4102
        • Recruiting
        • Princess Alexandra Hospital ( Site 5300)
        • Contact:
          • Study Coordinator
          • Phone Number: +61731766577
    • Victoria
      • Clayton, Victoria, Australia, 3168
        • Recruiting
        • Monash Health ( Site 5301)
        • Contact:
          • Study Coordinator
          • Phone Number: +61417607416
  • Chile
    • Region M. de Santiago
      • Santiago, Region M. de Santiago, Chile, 7500921
        • Recruiting
        • FALP ( Site 2100)
        • Contact:
          • Study Coordinator
          • Phone Number: +56224205098
      • Santiago, Region M. de Santiago, Chile, 8420383
        • Recruiting
        • Bradfordhill ( Site 2101)
        • Contact:
          • Study Coordinator
          • Phone Number: +56229490970
      • Santiago, Region M. de Santiago, Chile, 8330032
        • Recruiting
        • Pontificia Universidad Catolica de Chile ( Site 2102)
        • Contact:
          • Study Coordinator
          • Phone Number: +5690233407
  • China
    • Beijing Municipality
      • Beijing, Beijing Municipality, China, 100142
        • Recruiting
        • Beijing Cancer Hospital ( Site 5401)
        • Contact:
          • Study Coordinator
          • Phone Number: (010) 88121122
    • Fujian
      • Fuzhou, Fujian, China, 350014
        • Recruiting
        • Fujian Cancer Hospital ( Site 5413)
        • Contact:
          • Study Coordinator
          • Phone Number: 0591-62002053
    • Jiangsu
      • Nanjing, Jiangsu, China, 210008
        • Recruiting
        • Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School-Oncology ( Site 5403)
        • Contact:
          • Study Coordinator
          • Phone Number: 025-83106666
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, China, 200030
        • Recruiting
        • Shanghai Chest Hospital ( Site 5400)
        • Contact:
          • Study Coordinator
          • Phone Number: 021-22200000
      • Shanghai, Shanghai Municipality, China, 200433
        • Recruiting
        • Shanghai Pulmonary Hospital ( Site 5405)
        • Contact:
          • Study Coordinator
          • Phone Number: 15801709047
    • Sichuan
      • Chengdu, Sichuan, China, 610041
        • Recruiting
        • West China Hospital of Sichuan University ( Site 5416)
        • Contact:
          • Study Coordinator
          • Phone Number: 02885423237
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310000
        • Recruiting
        • The First Affiliated Hospital, Zhejiang University ( Site 5404)
        • Contact:
          • Study Coordinator
          • Phone Number: 13675843246
  • Israel
      • Haifa, Israel, 3109601
        • Active, not recruiting
        • Rambam Health Care Campus ( Site 3202)
      • Jerusalem, Israel, 9103102
        • Recruiting
        • Shaare Zedek Medical Center ( Site 3200)
        • Contact:
          • Study Coordinator
          • Phone Number: 026555768
      • Petah Tikva, Israel, 4941492
        • Recruiting
        • Rabin Medical Center ( Site 3203)
        • Contact:
          • Study Coordinator
          • Phone Number: +97239378101
      • Ramat Gan, Israel, 5265601
        • Recruiting
        • Sheba Medical Center ( Site 3201)
        • Contact:
          • Study Coordinator
          • Phone Number: 97235304498
  • Japan
    • Aichi-ken
      • Nagoya, Aichi-ken, Japan, 464-8681
        • Recruiting
        • Aichi Cancer Center ( Site 5000)
        • Contact:
          • Study Coordinator
          • Phone Number: +81-52-762-6111
    • Chiba
      • Kashiwa, Chiba, Japan, 277-0882
        • Recruiting
        • National Cancer Center Hospital East ( Site 5001)
        • Contact:
          • Study Coordinator
          • Phone Number: +81-4-7133-1111
    • Osaka
      • Hirakata, Osaka, Japan, 573-1191
        • Recruiting
        • Kansai Medical University Hospital ( Site 5004)
        • Contact:
          • Study Coordinator
          • Phone Number: +81-72-804-2808
    • Tokyo
      • Koto, Tokyo, Japan, 135-8550
        • Recruiting
        • Cancer Institute Hospital of JFCR ( Site 5002)
        • Contact:
          • Study Coordinator
          • Phone Number: +81-3-3520-0111
  • South Korea
      • Seoul, South Korea, 03080
        • Recruiting
        • Seoul National University Hospital ( Site 5100)
        • Contact:
          • Study Coordinator
          • Phone Number: +82220723559
      • Seoul, South Korea, 06351
        • Recruiting
        • Samsung Medical Center ( Site 5101)
        • Contact:
          • Study Coordinator
          • Phone Number: +82234101795
      • Seoul, South Korea, 03722
        • Recruiting
        • Severance Hospital, Yonsei University Health System ( Site 5102)
        • Contact:
          • Study Coordinator
          • Phone Number: +82215991004
  • Spain
      • Barcelona, Spain, 08035
        • Recruiting
        • Hospital Universitari Vall d'Hebron ( Site 3311)
        • Contact:
          • Study Coordinator
          • Phone Number: +34934894158
      • Madrid, Spain, 28040
        • Recruiting
        • Hospital Universitario Fundación Jiménez Díaz-START Madrid-FJD ( Site 3315)
        • Contact:
          • Study Coordinator
          • Phone Number: +34915504800ext2805
      • Madrid, Spain, 28050
        • Recruiting
        • Hospital Universitario HM Sanchinarro ( Site 3313)
        • Contact:
          • Study Coordinator
          • Phone Number: +34917567984
      • Málaga, Spain, 29010
        • Recruiting
        • Hospital Universitario Virgen de la Victoria ( Site 3312)
        • Contact:
          • Study Coordinator
          • Phone Number: +34671594566
    • Barcelona
      • Eixample, Barcelona, Spain, 08036
        • Recruiting
        • HOSPITAL CLÍNIC DE BARCELONA ( Site 3310)
        • Contact:
          • Study Coordinator
          • Phone Number: +34932275402
      • L'Hospitalet de Llobregat, Barcelona, Spain, 08907
        • Recruiting
        • Institut Català d'Oncologia - L'Hospitalet ( Site 3317)
        • Contact:
          • Study Coordinator
          • Phone Number: +34932607744
    • Madrid, Comunidad de
      • Madrid, Madrid, Comunidad de, Spain, 28040
        • Recruiting
        • Hospital Clinico San Carlos... ( Site 3316)
        • Contact:
          • Study Coordinator
          • Phone Number: 34913303000x484804
  • Taiwan
      • Tainan, Taiwan, 704
        • Recruiting
        • National Cheng Kung University Hospital ( Site 5202)
        • Contact:
          • Study Coordinator
          • Phone Number: +88662353535
      • Taipei, Taiwan, 11030
        • Recruiting
        • Taipei Medical University Hospital ( Site 5201)
        • Contact:
          • Study Coordinator
          • Phone Number: +886227372181
  • Turkey (Türkiye)
      • Ankara, Turkey (Türkiye), 06230
        • Recruiting
        • Hacettepe Universite Hastaneleri ( Site 3410)
        • Contact:
          • Study Coordinator
          • Phone Number: +903123055000
      • Ankara, Turkey (Türkiye), 06800
        • Recruiting
        • Ankara Bilkent Sehir Hastanesi ( Site 3412)
        • Contact:
          • Study Coordinator
          • Phone Number: +90312 552 6084
  • United Kingdom
      • Liverpool, United Kingdom, L7 8YA
        • Recruiting
        • The Clatterbridge Cancer Centre ( Site 3903)
        • Contact:
          • Study Coordinator
          • Phone Number: 00441515565000
      • Manchester, United Kingdom, M20 4BX
        • Recruiting
        • The Christie NHS Foundation Trust ( Site 3901)
        • Contact:
          • Study Coordinator
          • Phone Number: +441614463000
    • London, City of
      • London, London, City of, United Kingdom, W1T 7HA
        • Recruiting
        • National Institute for Health Research UCLH Clinical Research Facility ( Site 3902)
        • Contact:
          • Study Coordinator
          • Phone Number: +442034472930
  • United States
    • Colorado
      • Aurora, Colorado, United States, 80045
        • Recruiting
        • University of Colorado Anschutz Medical Campus ( Site 1110)
        • Contact:
          • Study Coordinator
          • Phone Number: 303-724-6268
    • Florida
      • Miami, Florida, United States, 33136
        • Recruiting
        • University of Miami Hospital and Clinics, Sylvester Cancer Center ( Site 1111)
        • Contact:
          • Study Coordinator
          • Phone Number: 305-243-1754
    • Illinois
      • Chicago, Illinois, United States, 60637
        • Recruiting
        • University of Chicago ( Site 1108)
        • Contact:
          • Study Coordinator
          • Phone Number: 773-702-6149
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Recruiting
        • Dana Farber Cancer Institute ( Site 1105)
        • Contact:
          • Study Coordinator
          • Phone Number: 617-632-6049
    • New Jersey
      • Hackensack, New Jersey, United States, 07601
        • Recruiting
        • John Theurer Cancer Center at Hackensack University Medical Center ( Site 1103)
        • Contact:
          • Study Coordinator
          • Phone Number: 551-996-5863
    • New York
      • Buffalo, New York, United States, 14263
        • Recruiting
        • Roswell Park Cancer Institute ( Site 1107)
        • Contact:
          • Study Coordinator
          • Phone Number: 716-845-3167
    • Oregon
      • Portland, Oregon, United States, 97213
        • Recruiting
        • Providence Portland Medical Center ( Site 1101)
        • Contact:
          • Study Coordinator
          • Phone Number: 503-215-5696
    • Tennessee
      • Nashville, Tennessee, United States, 37203
        • Recruiting
        • Sarah Cannon Research Institute ( Site 7001)
        • Contact:
          • Study Coordinator
          • Phone Number: 844-482-4812
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53226
        • Recruiting
        • Medical College of Wisconsin ( Site 1112)
        • Contact:
          • Study Coordinator
          • Phone Number: 414-805-8900

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Has histologically or cytologically confirmed SCLC that is extensive stage (defined as Stage IV (T any, N any, M1a/b/c) following at least 1 prior line of systemic therapy that included platinum-based chemotherapy
  • Must be able to provide archival tumor tissue sample or fresh biopsy tissue sample
  • Human immunodeficiency virus (HIV) infected participants must have well controlled HIV on antiretroviral therapy (ART)

Exclusion Criteria:

  • Pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedure
  • History of interstitial lung disease (ILD)/pneumonitis irrespective of steroid use or has current or suspected pneumonitis/ILD that cannot be ruled out by imaging at screening
  • Has clinically severe pulmonary compromise resulting from intercurrent pulmonary illnesses
  • Active or history of immune deficiency with the exception of HIV-infected participants with well controlled HIV on ART
  • History within 6 months before the first dose of study intervention of coronary/peripheral artery bypass graft and/or any coronary/peripheral angioplasty or clinically significant cardiovascular disease such as myocardial infarction, symptomatic congestive heart failure (CHF) (New York Heart Association > class II), and/or uncontrolled cardiac arrhythmia
  • History of arterial thrombosis (eg, stroke or transient ischemic attack) within 6 months before the first dose of study intervention
  • Active clinically significant infection requiring systemic therapy
  • History of allogeneic tissue/solid organ transplant
  • History of leptomeningeal disease
  • Received prior radiotherapy within 2 weeks of start of study intervention, or has radiation-related toxicities, requiring corticosteroids
  • Receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of chronic immunosuppressive therapy within 7 days prior to the first dose of study intervention
  • Known additional malignancy that is progressing or has required active treatment within the past 3 years
  • Untreated or symptomatic brain metastases
  • Active viral hepatitis, defined as hepatitis A (hepatitis A virus immunoglobulin M [IgM] positive in the setting of associated signs/symptoms), hepatitis B (hepatitis B virus surface antigen [HbsAg] positive and/or detectable hepatitis B virus [HBV] deoxyribonucleic acid [DNA]), or hepatitis C (hepatitis C virus [HCV] antibody positive and detectable HCV ribonucleic acid). Participants with HBV with undetectable viral load after treatment are eligible. Participants with HCV with undetectable virus after treatment are eligible.
  • Part 1 only: Radiation therapy to the lung >30 Gy within 6 months before the start of study intervention
  • Part 1 only: Abdominal radiation within 4 weeks before start of study intervention
  • Part 1 only: Anticancer hormonal treatment (except luteinizing hormone-releasing hormone [LHRH]) within 2 weeks before start of study intervention
  • Part 1 only: Systemic anticancer therapy (except antibody-based anticancer therapy) or investigational agents within 3 weeks or 5 half-lives, whichever is longer
  • Part 1 only: Antibody-based cancer therapy within 3 weeks before start of study intervention
  • Part 1 only: Chloroquine/hydroxychloroquine within 2 weeks before start of study intervention
  • Part 1 only: Clinically significant corneal disease
  • Part 1 only: Has other uncontrolled or significant protocol-specified cardiovascular disease

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Part 1 Arm 1: Gocatamig and I-DXd
Participants will receive gocatamig and I-DXd at a determined dose until documented disease progression or discontinuation criteria are met.
Biological: Ifinatamab Deruxtecan (I-DXd)
IV infusion
Other Names:
  • DS-7300a
  • MK-2400
Biological: Gocatamig
IV infusion
Other Names:
  • HPN328
  • MK-6070
Experimental: Part 1 Arm 2: Gocatamig and I-DXd
Participants will receive gocatamig and I-DXd at a determined dose until documented disease progression or discontinuation criteria are met.
Biological: Ifinatamab Deruxtecan (I-DXd)
IV infusion
Other Names:
  • DS-7300a
  • MK-2400
Biological: Gocatamig
IV infusion
Other Names:
  • HPN328
  • MK-6070
Experimental: Part 1 Arm 3a: I-DXd Monotherapy
Participants will receive I-DXd until documented disease progression or discontinuation criteria are met.
Biological: Ifinatamab Deruxtecan (I-DXd)
IV infusion
Other Names:
  • DS-7300a
  • MK-2400
Experimental: Part 1 Arm 3b: Gocatamig and I-DXd
Participants will receive gocatamig and I-DXd at a determined dose until documented disease progression or discontinuation criteria are met.
Biological: Ifinatamab Deruxtecan (I-DXd)
IV infusion
Other Names:
  • DS-7300a
  • MK-2400
Biological: Gocatamig
IV infusion
Other Names:
  • HPN328
  • MK-6070
Experimental: Part 2 Arm 4: Gocatamig Monotherapy in Japan
Participants in Japan will receive escalating doses of gocatamig until documented disease progression or discontinuation criteria are met.
Biological: Gocatamig
IV infusion
Other Names:
  • HPN328
  • MK-6070
Experimental: Part 2 Arm 5: Gocatamig Monotherapy in China
Participants in China will receive escalating doses of gocatamig until documented disease progression or discontinuation criteria are met.
Biological: Gocatamig
IV infusion
Other Names:
  • HPN328
  • MK-6070
Experimental: Part 2 Arm 6: Gocatamig
Participants will receive gocatamig at a determined dose until documented disease progression or discontinuation criteria are met.
Biological: Gocatamig
IV infusion
Other Names:
  • HPN328
  • MK-6070
Experimental: Part 3 Arm 7: Gocatamig and Durvalumab
Participants will receive gocatamig and durvalumab at a determined dose until documented disease progression or discontinuation criteria are met.
Biological: Gocatamig
IV infusion
Other Names:
  • HPN328
  • MK-6070
Biological: Durvalumab
IV infusion
Experimental: Part 2 Arm 8: Gocatamig (Alternate Presentation)
Participants will receive an alternate presentation of gocatamig at a determined dose until documented disease progression or discontinuation criteria are met.
Biological: Gocatamig
IV infusion
Other Names:
  • HPN328
  • MK-6070

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants Who Experience an Adverse Event (AE)
Time Frame: Up to approximately 44 months
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. The number of participants who experience an AE in the study will be presented.
Up to approximately 44 months
Number of Participants Who Experience One or More Dose-Limiting Toxicities (DLTs)
Time Frame: Up to approximately 3 weeks
A DLT is defined as any drug-related adverse event (AE) observed during the DLT evaluation period that meet pre-defined DTL criteria. Toxicities will be graded using National Cancer Institute Common Terminology for Adverse Events (NCI CTCAE) version 5.0, or the American Society for Transplant and Cellular Therapy (ASTCT) criteria. The number of participants who experience at least one DLT will be presented.
Up to approximately 3 weeks
Number of Participants Who Discontinue Study Intervention Due to an AE
Time Frame: Up to approximately 44 months
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. The number of participants who discontinue the study intervention due to an AE in the study will be presented.
Up to approximately 44 months
Part 1: Objective Response Rate (ORR)
Time Frame: Up to approximately 44 months
ORR is defined as the percentage of participants with Complete Response (CR: disappearance of all target lesions) or Partial Response (PR: at least a 30% decrease in the sum of diameters of target lesions) per Response Evaluation Criteria In Solid Tumors Version 1.1 (RECIST 1.1). The percentage of participants who experience CR or PR as assessed by the investigator will be presented.
Up to approximately 44 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Maximum Concentration (Cmax) of gocatamig
Time Frame: At designated timepoints (up to approximately 44 months)
Cmax is the maximum concentration of the study drug observed in plasma. Blood samples collected pre dose and at multiple timepoints post dose will be used to determine Cmax of the drug gocatamig.
At designated timepoints (up to approximately 44 months)
Cmax of ifinatamab deruxtecan (I-DXd)
Time Frame: At designated timepoints (up to approximately 44 months)
Cmax is the maximum concentration of the study drug observed in plasma. Blood samples collected pre dose and at multiple timepoints post dose will be used to determine Cmax of the drug I-DXd.
At designated timepoints (up to approximately 44 months)
Cmax of Anti-B7-H3 Antibody
Time Frame: At designated timepoints (up to approximately 44 months)
Cmax is the maximum concentration of the study drug observed in plasma. Blood samples collected pre dose and at multiple timepoints post dose will be used to determine Cmax of the anti-B7-H3 antibody.
At designated timepoints (up to approximately 44 months)
Cmax of Deruxtecan (DXd)
Time Frame: At designated timepoints (up to approximately 44 months)
Cmax is the maximum concentration of the study drug observed in plasma. Blood samples collected pre dose and at multiple timepoints post dose will be used to determine Cmax of the drug payload deruxtecan (DXd).
At designated timepoints (up to approximately 44 months)
Time to maximum concentration (Tmax) of gocatamig
Time Frame: At designated timepoints (up to approximately 44 months)
Tmax is the amount of time that a drug is present at the maximum concentration is observed in plasma. Blood samples will be collected to determine the Tmax of the drug gocatamig.
At designated timepoints (up to approximately 44 months)
Tmax of I-DXd
Time Frame: At designated timepoints (up to approximately 44 months)
Tmax is the amount of time that a drug is present at the maximum concentration is observed in plasma. Blood samples will be collected to determine the Tmax of the drug I-DXd.
At designated timepoints (up to approximately 44 months)
Tmax of Anti-B7-H3 Antibody
Time Frame: At designated timepoints (up to approximately 44 months)
Tmax is the amount of time that the drug is present at the maximum concentration is observed in plasma. Blood samples will be collected to determine the Tmax of the anti-B7-H3 antibody.
At designated timepoints (up to approximately 44 months)
Tmax of DXd
Time Frame: At designated timepoints (up to approximately 44 months)
Tmax is the amount of time that the drug is present at the maximum concentration is observed in plasma. Blood samples will be collected to determine the Tmax of the drug payload DXd.
At designated timepoints (up to approximately 44 months)
Area Under the Concentration-Time Curve Over the Dosing Interval t (AUCt) of gocatamig
Time Frame: At designated timepoints (up to approximately 44 months)
AUCt is a measure of plasma drug concentration and time and is estimated as the area under the plot of plasma concentration against time after drug administration. Blood samples will be collected to determine the AUCt of the drug gocatamig.
At designated timepoints (up to approximately 44 months)
AUCt of I-DXd
Time Frame: At designated timepoints (up to approximately 44 months)
AUCt is a measure of plasma drug concentration and time and is estimated as the area under the plot of plasma concentration against time after drug administration. Blood samples will be collected to determine the AUCt of the drug I-DXd.
At designated timepoints (up to approximately 44 months)
AUCt of Anti-B7-H3 Antibody
Time Frame: At designated timepoints (up to approximately 44 months)
AUCt is a measure of plasma drug concentration and time and is estimated as the area under the plot of plasma concentration against time after drug administration. Blood samples will be collected to determine the AUCt of the anti-B7-H3 antibody.
At designated timepoints (up to approximately 44 months)
AUCt of DXd
Time Frame: At designated timepoints (up to approximately 44 months)
AUCt is a measure of plasma drug concentration and time and is estimated as the area under the plot of plasma concentration against time after drug administration. Blood samples will be collected to determine the AUCt of the drug payload Dxd.
At designated timepoints (up to approximately 44 months)
Terminal Half-Life (t1/2) of gocatamig
Time Frame: At designated timepoints (up to approximately 44 months)
t½ is defined as the time required for plasma drug concentration of study drug to decrease by 50% from peak. Blood samples will be collected to determine the t1/2 of the drug gocatamig.
At designated timepoints (up to approximately 44 months)
t1/2 of I-DXd
Time Frame: At designated timepoints (up to approximately 44 months)
t½ is defined as the time required for plasma drug concentration of study drug to decrease by 50% from peak. Blood samples will be collected to determine the t1/2 of the drug I-DXd.
At designated timepoints (up to approximately 44 months)
t1/2 of Anti-B7-H3 Antibody
Time Frame: At designated timepoints (up to approximately 44 months)
t½ is defined as the time required for plasma drug concentration of study drug to decrease by 50% from peak. Blood samples will be collected to determine the t1/2 of the anti-B7-H3 antibody.
At designated timepoints (up to approximately 44 months)
t1/2 of DXd
Time Frame: At designated timepoints (up to approximately 44 months)
t½ is defined as the time required for plasma drug concentration of study drug to decrease by 50% from peak. Blood samples will be collected to determine the t1/2 of the drug payload DXd.
At designated timepoints (up to approximately 44 months)
Steady State Maximum Concentration (Cmax,ss) of gocatamig
Time Frame: At designated timepoints (up to approximately 44 months)
Cmax,ss is a measure of the maximum level of drug in the blood, measured at steady state (time at which the amount of drug eliminated by the body is in equilibrium with the amount taken in). Blood samples will be collected to determine the Cmax,ss of the drug gocatamig.
At designated timepoints (up to approximately 44 months)
Cmax,ss of I-DXd
Time Frame: At designated timepoints (up to approximately 44 months)
Cmax,ss is a measure of the maximum level of drug in the blood, measured at steady state (time at which the amount of drug eliminated by the body is in equilibrium with the amount taken in). Blood samples will be collected to determine the Cmax,ss of the drug I-DXd.
At designated timepoints (up to approximately 44 months)
Cmax,ss of Anti-B7-H3 Antibody
Time Frame: At designated timepoints (up to approximately 44 months)
Cmax,ss is a measure of the maximum level of drug in the blood, measured at steady state (time at which the amount of drug eliminated by the body is in equilibrium with the amount taken in). Blood samples will be collected to determine the Cmax,ss of the anti-B7-H3 antibody.
At designated timepoints (up to approximately 44 months)
Cmax,ss of DXd
Time Frame: At designated timepoints (up to approximately 44 months)
Cmax,ss is a measure of the maximum level of drug in the blood, measured at steady state (time at which the amount of drug eliminated by the body is in equilibrium with the amount taken in). Blood samples will be collected to determine the Cmax,ss of the drug payload DXd.
At designated timepoints (up to approximately 44 months)
Steady State Ctrough (Ctrough,ss) of gocatamig
Time Frame: At designated timepoints (up to approximately 44 months)
Ctrough,ss is defined as the trough concentration measured at steady state (time at which the amount of drug eliminated by the body is in equilibrium with the amount taken in). Blood samples will be collected to determine the Ctrough,ss of the drug gocatamig.
At designated timepoints (up to approximately 44 months)
Ctrough,ss of I-DXd
Time Frame: At designated timepoints (up to approximately 44 months)
Ctrough,ss is defined as the trough concentration measured at steady state (time at which the amount of drug eliminated by the body is in equilibrium with the amount taken in). Blood samples will be collected to determine the Ctrough,ss of the drug I-DXd.
At designated timepoints (up to approximately 44 months)
Ctrough,ss of Anti-B7-H3 Antibody
Time Frame: At designated timepoints (up to approximately 44 months)
Ctrough,ss is defined as the trough concentration measured at steady state (time at which the amount of drug eliminated by the body is in equilibrium with the amount taken in). Blood samples will be collected to determine the Ctrough,ss of the anti-B7-H3 antibody.
At designated timepoints (up to approximately 44 months)
Ctrough,ss of DXd
Time Frame: At designated timepoints (up to approximately 44 months)
Ctrough,ss is defined as the trough concentration measured at steady state (time at which the amount of drug eliminated by the body is in equilibrium with the amount taken in). Blood samples will be collected to determine the Ctrough,ss of the drug payload DXd.
At designated timepoints (up to approximately 44 months)
Steady State Time to Maximum Concentration (Tmax,ss) of gocatamig
Time Frame: At designated timepoints (up to approximately 44 months)
Tmax,ss is the amount of time that a drug is present at the maximum concentration is observed in plasma measured at steady state (time at which the amount of drug eliminated by the body is in equilibrium with the amount taken in). Blood samples will be collected to determine the Tmax,ss of the drug gocatamig.
At designated timepoints (up to approximately 44 months)
Tmax,ss of I-DXd
Time Frame: At designated timepoints (up to approximately 44 months)
Tmax,ss is the amount of time that a drug is present at the maximum concentration is observed in plasma measured at steady state (time at which the amount of drug eliminated by the body is in equilibrium with the amount taken in). Blood samples will be collected to determine the Tmax,ss of the drug I-DXd.
At designated timepoints (up to approximately 44 months)
Tmax,ss of Anti-B7-H3 Antibody
Time Frame: At designated timepoints (up to approximately 44 months)
Tmax,ss is the amount of time that a drug is present at the maximum concentration is observed in plasma measured at steady state (time at which the amount of drug eliminated by the body is in equilibrium with the amount taken in). Blood samples will be collected to determine the Tmax,ss of the anti-B7-H3 antibody.
At designated timepoints (up to approximately 44 months)
Tmax,ss of DXd
Time Frame: At designated timepoints (up to approximately 44 months)
Tmax,ss is the amount of time that a drug is present at the maximum concentration is observed in plasma measured at steady state (time at which the amount of drug eliminated by the body is in equilibrium with the amount taken in). Blood samples will be collected to determine the Tmax,ss of the drug payload DXd.
At designated timepoints (up to approximately 44 months)
Area Under the Steady State Concentration-Time Curve Over Dosing Interval t (AUCt,ss) of gocatamig
Time Frame: At designated timepoints (up to approximately 44 months)
AUCt,ss is a measure of plasma drug concentration and time and is estimated as the area under the plot of plasma concentration against time after drug administration measured at steady state (time at which the amount of drug eliminated by the body is in equilibrium with the amount taken in). Blood samples will be collected to determine the AUCt,ss of the drug gocatamig.
At designated timepoints (up to approximately 44 months)
AUCt,ss of I-DXd
Time Frame: At designated timepoints (up to approximately 44 months)
AUCt,ss is a measure of plasma drug concentration and time and is estimated as the area under the plot of plasma concentration against time after drug administration measured at steady state (time at which the amount of drug eliminated by the body is in equilibrium with the amount taken in). Blood samples will be collected to determine the AUCt,ss of the drug I-DXd.
At designated timepoints (up to approximately 44 months)
AUCt,ss of Anti-B7-H3 Antibody
Time Frame: At designated timepoints (up to approximately 44 months)
AUCt,ss is a measure of plasma drug concentration and time and is estimated as the area under the plot of plasma concentration against time after drug administration measured at steady state (time at which the amount of drug eliminated by the body is in equilibrium with the amount taken in). Blood samples will be collected to determine the AUCt,ss of the anti-B7-H3 antibody.
At designated timepoints (up to approximately 44 months)
AUCt,ss of DXd
Time Frame: At designated timepoints (up to approximately 44 months)
AUCt,ss is a measure of plasma drug concentration and time and is estimated as the area under the plot of plasma concentration against time after drug administration measured at steady state (time at which the amount of drug eliminated by the body is in equilibrium with the amount taken in). Blood samples will be collected to determine the AUCt,ss of the drug payload DXd.
At designated timepoints (up to approximately 44 months)
Steady state t1/2 (t1/2,ss) of gocatamig
Time Frame: At designated timepoints (up to approximately 44 months)
t1/2,ss is defined as the time required for plasma drug concentration of study drug to decrease by 50% from peak measured at steady state (time at which the amount of drug eliminated by the body is in equilibrium with the amount taken in). Blood samples will be collected to determine the t1/2,ss of the drug gocatamig.
At designated timepoints (up to approximately 44 months)
t1/2,ss of I-DXd
Time Frame: At designated timepoints (up to approximately 44 months)
t1/2,ss is defined as the time required for plasma drug concentration of study drug to decrease by 50% from peak measured at steady state (time at which the amount of drug eliminated by the body is in equilibrium with the amount taken in). Blood samples will be collected to determine the t1/2,ss of the drug I-DXd.
At designated timepoints (up to approximately 44 months)
t1/2,ss of Anti-B7-H3 Antibody
Time Frame: At designated timepoints (up to approximately 44 months)
t1/2,ss is defined as the time required for plasma drug concentration of study drug to decrease by 50% from peak measured at steady state (time at which the amount of drug eliminated by the body is in equilibrium with the amount taken in). Blood samples will be collected to determine the t1/2,ss of the anti-B7-H3 antibody.
At designated timepoints (up to approximately 44 months)
t1/2,ss of DXd
Time Frame: At designated timepoints (up to approximately 44 months)
t1/2,ss is defined as the time required for plasma drug concentration of study drug to decrease by 50% from peak measured at steady state (time at which the amount of drug eliminated by the body is in equilibrium with the amount taken in). Blood samples will be collected to determine the t1/2,ss of the drug payload DXd.
At designated timepoints (up to approximately 44 months)
Accumulation Ratio (AC) of gocatamig
Time Frame: At designated timepoints (up to approximately 44 months)
Blood samples will be collected to determine the AC of the drug gocatamig.
At designated timepoints (up to approximately 44 months)
AC of I-DXd
Time Frame: At designated timepoints (up to approximately 44 months)
Blood samples will be collected to determine the AC of the drug I-DXd.
At designated timepoints (up to approximately 44 months)
AC of Anti-B7-H3 Antibody
Time Frame: At designated timepoints (up to approximately 44 months)
Blood samples will be collected to determine the AC of the anti-B7-H3 antibody.
At designated timepoints (up to approximately 44 months)
AC of DXd
Time Frame: At designated timepoints (up to approximately 44 months)
Blood samples will be collected to determine the AC of the drug payload DXd.
At designated timepoints (up to approximately 44 months)
Incidence of Anti-Drug Antibodies (ADAs) Against gocatamig
Time Frame: At designated timepoints (up to approximately 44 months)
Blood samples collected at designated timepoints will be used to determine the ADA response to gocatamig. The incidence of ADAs for gocatamig will be presented.
At designated timepoints (up to approximately 44 months)
Cmax of Durvalumab
Time Frame: At designated timepoints (up to approximately 44 months)
Cmax is the maximum concentration of the study drug observed in plasma. Blood samples collected pre dose and at multiple timepoints post dose will be used to determine Cmax of durvalumab.
At designated timepoints (up to approximately 44 months)
Cmax,ss of Durvalumab
Time Frame: At designated timepoints (up to approximately 44 months)
Cmax,ss is a measure of the maximum level of drug in the blood, measured at steady state (time at which the amount of drug eliminated by the body is in equilibrium with the amount taken in). Blood samples will be collected to determine the Cmax,ss of the durvalumab.
At designated timepoints (up to approximately 44 months)
Ctrough,ss of Durvalumab
Time Frame: At designated timepoints (up to approximately 44 months)
Ctrough,ss is defined as the trough concentration measured at steady state (time at which the amount of drug eliminated by the body is in equilibrium with the amount taken in). Blood samples will be collected to determine the Ctrough,ss of durvalumab.
At designated timepoints (up to approximately 44 months)
Incidence of ADAs Against I-DXd
Time Frame: At designated timepoints (up to approximately 44 months)
Blood samples collected at designated timepoints will be used to determine the ADA response to I-DXd. The incidence of ADAs for I-DXd will be presented.
At designated timepoints (up to approximately 44 months)
Incidence of ADAs Against Durvalumab
Time Frame: At designated timepoints (up to approximately 44 months)
Blood samples collected at designated timepoints will be used to determine the ADA response to durvalumab. The incidence of ADAs for durvalumab will be presented.
At designated timepoints (up to approximately 44 months)
Part 1, Part 2 (Arm 5, Arm 6, and Arm 8), and Part 3 (Arm 7): Duration of Response (DOR)
Time Frame: Up to approximately 44 months
For participants who demonstrate a confirmed Complete Response (CR: disappearance of all target lesions) or Partial Response (PR: at least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1, DOR is defined as the time from first documented evidence of CR or PR until progressive disease (PD) or death. Per RECIST 1.1, PD is defined as at least a 20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered PD. DOR as assessed by the investigator will be presented.
Up to approximately 44 months
Part 1, Part 2 (Arm 6 and Arm 8), and Part 3 (Arm 7): Progression-Free Survival (PFS)
Time Frame: Up to approximately 44 months
PFS is defined as the time from randomization to the first documented PD or death due to any cause, whichever occurs first as assessed by RECIST 1.1. PD is defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. The appearance of one or more new lesions is also considered PD. PFS as assessed by the investigator will be presented.
Up to approximately 44 months
Part 2 (Arm 5, Arm 6, and Arm 8) and Part 3 (Arm 7): ORR
Time Frame: Up to approximately 44 months
ORR is defined as the percentage of participants with Complete Response (CR: disappearance of all target lesions) or Partial Response (PR: at least a 30% decrease in the sum of diameters of target lesions) per Response Evaluation Criteria In Solid Tumors Version 1.1 (RECIST 1.1). The percentage of participants who experience CR or PR as assessed by the investigator will be presented.
Up to approximately 44 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Merck Sharp & Dohme LLC

Collaborators

Daiichi Sankyo

Investigators

  • Study Director: Medical Director, Merck Sharp & Dohme LLC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 27, 2025

Primary Completion (Estimated)

August 31, 2029

Study Completion (Estimated)

January 17, 2030

Study Registration Dates

First Submitted

January 13, 2025

First Submitted That Met QC Criteria

January 13, 2025

First Posted (Actual)

January 17, 2025

Study Record Updates

Last Update Posted (Actual)

April 20, 2026

Last Update Submitted That Met QC Criteria

April 17, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 6070-002
  • MK-6070-002 (Other Identifier: MSD)
  • 2024-517926-25-00 (Registry Identifier: EU CT)
  • jRCT2031250039 (Registry Identifier: Japan Registry of Clinical Trials (jRCT))

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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