Study to Determine the Safety, Tolerability, Pharmacokinetics and Recommended Phase 2 Dose (RP2D) of Livmoniplimab (ABBV-151) as a Single Agent and in Combination With Budigalimab (ABBV-181) in Participants With Locally Advanced or Metastatic Solid Tumors

A Phase 1 First-in Human, Multi-Center, Open Label Dose-Escalation Study to Determine the Safety, Tolerability, Pharmacokinetics and RP2D of Livmoniplimab (ABBV-151) as a Single Agent and in Combination With Budigalimab (ABBV-181) in Subjects With Locally Advanced or Metastatic Solid Tumors

The study will determine the recommended Phase 2 dose (RP2D) of livmoniplimab (ABBV-151) administered as monotherapy and in combination with budigalimab (ABBV-181) as well as to assess the safety, tolerability, pharmacokinetics (PK), and preliminary efficacy of livmoniplimab alone and in combination with budigalimab. The study will consist of 2 parts: dose escalation and dose expansion.

Study Overview

• Status: Recruiting
• Conditions: Advanced Solid Tumors Cancer
• Intervention / Treatment: Drug: Budigalimab; Drug: Livmoniplimab

• Study Type: Interventional
• Enrollment (Estimated): 362
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: ABBVIE CALL CENTER; Phone Number: 844-663-3742; Email: abbvieclinicaltrials@abbvie.com

Study Locations

• Australia
  • New South Wales
    • Camperdown, New South Wales, Australia, 2050
      • Recruiting
      • Chris O'Brien Lifehouse /ID# 213236
  • Queensland
    • South Brisbane, Queensland, Australia, 4101
      • Recruiting
      • Icon Cancer Centre /ID# 224961
• Belgium
  • Bruxelles-Capitale
    • Woluwe-Saint-Lambert, Bruxelles-Capitale, Belgium, 1200
      • Recruiting
      • UCL Saint-Luc /ID# 218466
• Canada
  • Ontario
    • Toronto, Ontario, Canada, M5G 2M9
      • Completed
      • Princess Margaret Cancer Centre /ID# 209423
• France
  • Clermont Ferrand, France, 63011
    • Completed
    • Centre Jean Perrin /ID# 218669
  • Haute-Garonne
    • TOULOUSE Cedex 9, Haute-Garonne, France, 31059
      • Completed
      • CHU Toulouse - Hopital Purpan /ID# 218667
  • Rhone
    • Lyon CEDEX 08, Rhone, France, 69373
      • Completed
      • Centre Leon Berard /ID# 218515
  • Val-de-Marne
    • Villejuif Cedex, Val-de-Marne, France, 94805
      • Completed
      • Institut Gustave Roussy /ID# 218668
• Israel
  • Haifa, Israel, 4941492
    • Recruiting
    • Rabin Medical Center /ID# 258479
  • Jerusalem, Israel, 91120
    • Recruiting
    • Hadassah Medical Center-Hebrew University /ID# 257918
  • H_efa
    • Haifa, H_efa, Israel, 3109601
      • Recruiting
      • Rambam Health Care Campus /ID# 222198
  • Tel-Aviv
    • Ramat Gan, Tel-Aviv, Israel, 5265601
      • Recruiting
      • The Chaim Sheba Medical Center /ID# 209037
    • Tel Aviv, Tel-Aviv, Israel, 6423906
      • Recruiting
      • Tel Aviv Sourasky Medical Center /ID# 222199
• Japan
  • Chiba
    • Kashiwa-shi, Chiba, Japan, 277-8577
      • Recruiting
      • National Cancer Center Hospital East /ID# 224808
  • Tokyo
    • Chuo-ku, Tokyo, Japan, 104-0045
      • Recruiting
      • National Cancer Center Hospital /ID# 209421
• Korea, Republic of
  • Seoul, Korea, Republic of, 03080
    • Recruiting
    • Seoul National University Hospital /ID# 218513
  • Gyeonggido
    • 남동구, Gyeonggido, Korea, Republic of, 21565
      • Recruiting
      • Gachon University Gil Medical Center /ID# 257572
  • Jeonranamdo
    • Hwasun-gun, Jeonranamdo, Korea, Republic of, 58128
      • Recruiting
      • Chonnam National University Hwasun Hospital /ID# 257573
  • Seoul Teugbyeolsi
    • Seoul, Seoul Teugbyeolsi, Korea, Republic of, 03722
      • Recruiting
      • Yonsei University Health System Severance Hospital /ID# 218512
• Puerto Rico
  • Rio Piedras, Puerto Rico, 00935
    • Recruiting
    • Pan American Center for Oncology Trials, LLC /ID# 217475
    • Contact: Site Coordinator; Phone Number: 844-663-3742
• Spain
  • Barcelona, Spain, 08036
    • Completed
    • Hospital Clinic de Barcelona /ID# 221106
  • Madrid, Spain, 28040
    • Recruiting
    • Hospital Universitario Fundacion Jimenez Diaz /ID# 220928
  • Valencia, Spain, 46010
    • Recruiting
    • Hospital Clinico Universitario de Valencia /ID# 221107
• Taiwan
  • Kaohsiung, Taiwan, 807
    • Recruiting
    • Kaohsiung Medical University Chung-Ho Memorial Hospital /ID# 257634
  • Taichung, Taiwan, 40447
    • Recruiting
    • China Medical University Hospital /ID# 218492
  • Taipei, Taiwan, 11217
    • Recruiting
    • Taipei Veterans General Hosp /ID# 257635
  • Taipei City, Taiwan, 100
    • Recruiting
    • National Taiwan University Hospital /ID# 218490
• United States
  • Connecticut
    • New Haven, Connecticut, United States, 06510
      • Recruiting
      • Yale University School of Medicine /ID# 208356
  • Florida
    • Celebration, Florida, United States, 34747-4970
      • Recruiting
      • AdventHealth Celebration /ID# 224860
    • Orlando, Florida, United States, 32804
      • Completed
      • Duplicate_AdventHealth Cancer Institute - Orlando /ID# 226953
  • Indiana
    • Indianapolis, Indiana, United States, 46202
      • Recruiting
      • Indiana Univ School Medicine /ID# 208384
    • Indianapolis, Indiana, United States, 46250-2042
      • Recruiting
      • Community Health Network, Inc. /ID# 257032
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • Completed
      • Univ Michigan Med Ctr /ID# 221129
  • Missouri
    • Saint Louis, Missouri, United States, 63110
      • Recruiting
      • Washington University-School of Medicine /ID# 259684
  • New York
    • New York, New York, United States, 10016-6402
      • Recruiting
      • NYU Langone Medical Center /ID# 209822
  • North Carolina
    • Huntersville, North Carolina, United States, 28078
      • Completed
      • Carolina BioOncology Institute /ID# 208358
  • Ohio
    • Columbus, Ohio, United States, 43210-1240
      • Recruiting
      • The Ohio State University - The James /ID# 217611
      • Contact: Site Coordinator; Phone Number: 844-663-3742
  • Texas
    • San Antonio, Texas, United States, 78229
      • Recruiting
      • NEXT Oncology /ID# 208930

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• For Dose Escalation only: Participants with an advanced solid tumor who are considered refractory to or intolerant of all existing therapy(ies) known to provide a clinical benefit for their condition. Additionally, participants who have been offered standard therapies and refused, or who are considered ineligible for standard therapies, may be eligible for this study on a case-by-case basis, after discussion with and agreement from the sponsor. Participants with pancreatic adenocarcinoma, urothelial cancer (UC), hepatocellular carcinoma (HCC), or head and neck squamous cell carcinoma (HNSCC) who are being considered for the dose escalation cohorts must also meet the histology specific eligibility criteria described below for dose expansion.

• For Dose Expansion only participants must meet criteria specific to the type of cancer:

  • Pancreatic adenocarcinoma and have disease progression during or after 1 systemic therapy (gemcitabine monotherapy or in combination with other agents, FOLFIRINOX [or another regimen including both 5-fluorouracil and oxaliplatin], capecitabine monotherapy or in combination with other agents) administered in the adjuvant, locally advanced, or metastatic setting. If the therapy was used in an adjuvant setting, disease progression must have occurred within 6 months of completing adjuvant therapy.
  • UC of the bladder and urinary tract and must have progressed following treatment with:
  • Cohort 4: A platinum-based regimen (administered in any line of therapy) and a programmed death 1/programmed death ligand 1 (PD1/PDL1) antagonist administered in the recurrent or metastatic setting (progression following a PD1/PDL1 antagonist is defined as unequivocal progression on or within 3 months of the last dose of anti-PD1 or anti-PDL1 therapy).
  • Cohort 11: One or more prior line of therapy in the locally advanced or metastatic setting. Participant must have experienced radiographic progression or relapse during or after a CPI (anti-PD1 or anti-PD-L1) for locally advanced or metastatic disease.
  • HCC and must have disease progression during or after 1 prior line of systemic therapy.
  • HNSCC (arising from the oral cavity, oropharynx, hypopharynx, or larynx) and must have progressed following treatment with platinum-based regimen (administered in any line of therapy) and a PD1/PDL1 antagonist administered in the recurrent or metastatic setting (progression following a PD1/PDL1 antagonist is defined as unequivocal progression on or within 3 months of the last dose of anti-PD1 or anti-PDL1 therapy).
  • Microsatellite stable colorectal cancer (MSS-CRC) [unselected] participants with microsatellite stable or mismatch repair proficient colorectal adenocarcinoma (as determined by polymerase chain reaction (PCR)/Next-Generation sequencing (NGS) or immunohistochemistry (IHC), respectively) who have received 1-2 prior chemotherapy regimens.
  • Non-small cell lung cancer (NSCLC) relapsed/refractory (R/R): Participants with histologically or cytologically confirmed advanced or metastatic NSCLC who have received 1 prior line of chemotherapy and 1 prior anti-PD-(L)1 antibody, administered either concurrently or sequentially in the metastatic setting.
  • MSS-CRC (CMS4 enriched): Participants with microsatellite stable or mismatch repair proficient colorectal adenocarcinoma who have received prior fluorouracil-based combination chemotherapy regimens including oxaliplatin and irinotecan (with or without VEGF and/or EGFR targeted agents) and with a CMS4 subtype as determined by NGS of tumor biopsies. Archival tissue must be submitted for assessment of CMS4 subtype status during prescreening. Participants must have progressed on or refused available standard of care therapies. Additionally, participant who are considered not appropriate or ineligible for available standard of care therapies per investigator assessment will be eligible for this study.
  • Ovarian granulosa (OG) cell tumor: Participants with histologically confirmed advanced nonresectable or metastatic adult granulosa cell tumor of the ovary that is not amenable to curative intent surgery or radiation. Additionally, there is documentation of radiological evidence of relapse after at least 1 line of systemic chemotherapy.
• Participant has an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 1.
• Participant has adequate bone marrow, renal, hepatic, and coagulation function.
• Must have a viral status consistent with the requirements described in the protocol specific to type of cancer and stage of study (Dose Escalation or Dose Expansion).

Exclusion Criteria:

• For Dose Expansion only:

  • Participants with HCC, pancreatic adenocarcinoma, or MSS-CRC having prior exposure to a prior PD-1/PD-L1 antagonist in any line of therapy.
  • Participants (except for participants with urothelial cancer or HNSCC) who have had prior exposure to immunotherapies as listed in the protocol.
• Has received anticancer therapy including chemotherapy, immunotherapy, radiation therapy, biologic, herbal therapy, or any investigational therapy within a period of 5 half-lives or 28 days (whichever is shorter), prior to the first dose of the study drug.
• Participant has unresolved AEs > Grade 1 from prior anticancer therapy except for alopecia.
• Has a history of primary immunodeficiency, bone marrow transplantation, solid organ transplantation, or previous clinical diagnosis of tuberculosis.
• Has a known uncontrolled metastases to the central nervous system (with certain exceptions).
• Current or prior use of immunosuppressive medication within 14 days prior to the first dose of the study drug.
• Has clinically significant uncontrolled condition(s).
• History of inflammatory bowel disease, interstitial lung disease or pneumonitis, myocarditis, Stevens-Johnson syndrome, toxic epidermal necrolysis or drug reaction with eosinophilia and systemic symptoms (DRESS).
• Live vaccine administration <= 28 days prior to the first dose of study drug.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

15

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Dose Escalation: Cohort 1 Livmoniplimab; Various doses of Livmoniplimab administered during dose escalation to determine the Recommended Phase 2 Dose (RP2D).	Drug: Livmoniplimab; Liquid for intravenous infusion.; Other Names: ABBV-151
Experimental: Dose Escalation: Cohort 2 Livmoniplimab + Budigalimab; Various doses of Livmoniplimab + Budigalimab administered during dose escalation to determine the Recommended Phase 2 Dose (RP2D).	Drug: Budigalimab; Lyophilized powder for solution for intravenous infusion.; Other Names: ABBV-181; Drug: Livmoniplimab; Liquid for intravenous infusion.; Other Names: ABBV-151
Experimental: Dose Expansion: Cohort 3 Livmoniplimab + Budigalimab; Participants with programmed cell death protein 1 (PD-1)-naïve pancreatic adenocarcinoma will receive livmoniplimab at the RP2D Q2W plus budigalimab Dose A administered Q4W.	Drug: Budigalimab; Lyophilized powder for solution for intravenous infusion.; Other Names: ABBV-181; Drug: Livmoniplimab; Liquid for intravenous infusion.; Other Names: ABBV-151
Experimental: Dose Expansion: Cohort 4 Livmoniplimab + Budigalimab; Participants with PD-1-ref urothelial cancer will receive livmoniplimab at the RP2D Q2W plus budigalimab Dose A administered Q4W.	Drug: Budigalimab; Lyophilized powder for solution for intravenous infusion.; Other Names: ABBV-181; Drug: Livmoniplimab; Liquid for intravenous infusion.; Other Names: ABBV-151
Experimental: Dose Expansion: Cohort 5 Livmoniplimab + Budigalimab; Participants with PD-1-naïve hepatocellular carcinoma (HCC) will receive livmoniplimab at the RP2D Q2W plus budigalimab Dose A administered Q4W.	Drug: Budigalimab; Lyophilized powder for solution for intravenous infusion.; Other Names: ABBV-181; Drug: Livmoniplimab; Liquid for intravenous infusion.; Other Names: ABBV-151
Experimental: Dose Expansion: Cohort 6 Livmoniplimab + Budigalimab; Participants with PD-1-ref head and neck squamous cell carcinoma (HNSCC) will receive livmoniplimab at the RP2D Q2W plus budigalimab Dose A administered Q4W.	Drug: Budigalimab; Lyophilized powder for solution for intravenous infusion.; Other Names: ABBV-181; Drug: Livmoniplimab; Liquid for intravenous infusion.; Other Names: ABBV-151
Experimental: Dose Expansion: Cohort 7 Livmoniplimab + Budigalimab; Participants with PD-1-naïve microsatellite stable colorectal cancer (MSS-CRC) [unselected] will receive livmoniplimab at the RP2D Q2W plus budigalimab Dose A administered Q4W.	Drug: Budigalimab; Lyophilized powder for solution for intravenous infusion.; Other Names: ABBV-181; Drug: Livmoniplimab; Liquid for intravenous infusion.; Other Names: ABBV-151
Experimental: Dose Expansion: Cohort 8 Livmoniplimab + Budigalimab; Participants with non-small cell lung cancer (NSCLC) [programmed death ligand 1 (PDL1) relapsed/refractory (R/R)] will receive livmoniplimab at the RP2D Q2W plus budigalimab Dose A administered Q4W.	Drug: Budigalimab; Lyophilized powder for solution for intravenous infusion.; Other Names: ABBV-181; Drug: Livmoniplimab; Liquid for intravenous infusion.; Other Names: ABBV-151
Experimental: Dose Expansion: Cohort 10A Livmoniplimab + Budigalimab; Participants with microsatellite stable colorectal cancer (MSS-CRC) [consensus molecular subtype 4 (CMS4) enriched] will receive livmoniplimab at the dose B Q3W plus budigalimab Dose B administered Q3W.	Drug: Budigalimab; Lyophilized powder for solution for intravenous infusion.; Other Names: ABBV-181; Drug: Livmoniplimab; Liquid for intravenous infusion.; Other Names: ABBV-151
Experimental: Dose Expansion: Cohort 10B Livmoniplimab + Budigalimab; Participants with MSS-CRC (CMS4 enriched) will receive livmoniplimab at the dose C Q3W plus budigalimab Dose B administered Q3W.	Drug: Budigalimab; Lyophilized powder for solution for intravenous infusion.; Other Names: ABBV-181; Drug: Livmoniplimab; Liquid for intravenous infusion.; Other Names: ABBV-151
Experimental: Dose Expansion: Cohort 11A Livmoniplimab + Budigalimab; Participants with PD-1-ref urothelial cancer will receive livmoniplimab at the Dose B Q3W plus budigalimab Dose B administered Q3W.	Drug: Budigalimab; Lyophilized powder for solution for intravenous infusion.; Other Names: ABBV-181; Drug: Livmoniplimab; Liquid for intravenous infusion.; Other Names: ABBV-151
Experimental: Dose Expansion: Cohort 11B Livmoniplimab + Budigalimab; Participants with PD-1-ref urothelial cancer will receive livmoniplimab at the Dose C Q3W plus budigalimab Dose B administered Q3W.	Drug: Budigalimab; Lyophilized powder for solution for intravenous infusion.; Other Names: ABBV-181; Drug: Livmoniplimab; Liquid for intravenous infusion.; Other Names: ABBV-151
Experimental: Dose Expansion: Cohort 11C Budigalimab; Participants with PD-1-ref urothelial cancer will receive budigalimab Dose B administered Q3W.	Drug: Budigalimab; Lyophilized powder for solution for intravenous infusion.; Other Names: ABBV-181
Experimental: Dose Expansion: Cohort 12A Livmoniplimab + Budigalimab; Participants with PD-1-naïve ovarian granulosa (OG) cell tumors will receive livmoniplimab at the Dose B Q3W plus budigalimab Dose B administered Q3W.	Drug: Budigalimab; Lyophilized powder for solution for intravenous infusion.; Other Names: ABBV-181; Drug: Livmoniplimab; Liquid for intravenous infusion.; Other Names: ABBV-151
Experimental: Dose Expansion: Cohort 12B Livmoniplimab + Budigalimab; Participants with PD-1-naïve ovarian granulosa (OG) cell tumors will receive livmoniplimab at the Dose C Q3W plus budigalimab Dose B administered Q3W.	Drug: Budigalimab; Lyophilized powder for solution for intravenous infusion.; Other Names: ABBV-181; Drug: Livmoniplimab; Liquid for intravenous infusion.; Other Names: ABBV-151

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Dose Expansion: Objective Response Rate (ORR)	ORR defined as the percentage of participants with a confirmed complete response (CR) or partial response (PR) based on Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.	Up to approximately 6 months after the first dose date of last participant in Dose Expansion
Dose Escalation: Recommended Phase 2 Dose (RP2D) Livmoniplimab Monotherapy	The RP2D is defined as the dose level chosen by the sponsor (in consultation with the investigators) for the dose expansion arms, based on safety, tolerability, efficacy, PK, and PD data collected during the dose escalation portion of the study.	Up to 28 days after the first dose of Livmoniplimab monotherapy
Dose Escalation: RP2D Livmoniplimab + Budigalimab Combination Therapy	The RP2D is defined as the dose level chosen by the sponsor (in consultation with the investigators) for the dose expansion arms, based on safety, tolerability, efficacy, pharmacokinetics (PK), and pharmacodynamic (PD) data collected during the dose escalation portion of the study.	Up to 28 days after the first dose of Livmoniplimab and Budigalimab combination therapy

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Dose Expansion: Duration of Response (DOR)	The DOR for a responder is defined as the time from the participant's initial objective response to the first date of either disease progression or death, whichever occurs first.	Up to approximately 6 months after the first dose date of last participant in Dose Expansion
Maximum Observed Serum Concentration (Cmax) of Budigalimab	Maximum Serum Concentration (Cmax) of budigalimab.	Up to approximately 70 days after initial dose of study drug
Time to Maximum Observed Serum Concentration (Tmax) of Budigalimab	Time to maximum serum concentration (Tmax) of budigalimab.	Up to approximately 70 days after initial dose of study drug
Area Under the Plasma Concentration-time Curve over time from 0 to last measurable concentration (AUCτ) of Budigalimab	Area under the serum concentration-time curve from time 0 to the time of the last measurable concentration (AUCτ) of budigalimab.	Up to approximately 70 days after initial dose of study drug
Terminal-phase Elimination Rate Constant (β) of Budigalimab	Apparent terminal phase elimination rate constant (β or Beta) of budigalimab.	Up to approximately 70 days after initial dose of study drug
Terminal Phase Elimination Half-life (t1/2) of Budigalimab	Terminal phase elimination half-life (t1/2) of budigalimab.	Up to approximately 70 days after initial dose of study drug
Number of Participants With Adverse Events (AEs)	An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. The investigator assesses the relationship of each event to the use of study. A serious adverse event (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the participant and may require medical or surgical intervention to prevent any of the outcomes listed above.	Up to approximately 9 months after the first dose date of last participant
Change in Vital Signs	Number of participants with clinically significant change from baseline in vital signs like systolic and diastolic blood pressure will be reported.	Up to approximately 6 months after the first dose date of last participant
Change in Laboratory Parameters	Number of participants with clinically significant change from baseline in clinical laboratory test results like hematology will be reported.	Up to approximately 6 months after the first dose date of last participant
Change in Electrocardiogram (ECG)	12-lead resting ECGs will be recorded. Parameters include RR interval, PR interval, QT interval, and QRS duration.	Up to approximately 6 months after the first dose date of last participant
Incidence of Anti-drug Antibody (ADA)	The number of participants with anti-drug antibodies.	Up to approximately 6 months after the first dose date of last participant
Dose Expansion: Progression-free Survival (PFS)	Progression-free survival is defined as the time from the participant's first dose of study treatment (livmoniplimab or budigalimab) to the first date of either disease progression or death, whichever occurs first.	Up to approximately 6 months after the first dose date of last participant in Dose Expansion
Maximum Observed Serum Concentration (Cmax) of Livmoniplimab	Maximum Serum Concentration (Cmax) of livmoniplimab.	Up to approximately 70 days after initial dose of study drug
Time to Maximum Observed Serum Concentration (Tmax) of Livmoniplimab	Time to maximum serum concentration (Tmax) of livmoniplimab.	Up to approximately 70 days after initial dose of study drug
Area Under the Plasma Concentration-time Curve over time from 0 to last measurable concentration (AUCτ) of Livmoniplimab	Area under the serum concentration-time curve from time 0 to the time of the last measurable concentration (AUCτ) of livmoniplimab.	Up to approximately 70 days after initial dose of study drug
Terminal-phase Elimination Rate Constant (β) of Livmoniplimab	Apparent terminal phase elimination rate constant (β or Beta) of livmoniplimab.	Up to approximately 70 days after initial dose of study drug
Terminal Phase Elimination Half-life (t1/2) of Livmoniplimab	Terminal phase elimination half-life (t1/2) of livmoniplimab.	Up to approximately 70 days after initial dose of study drug
Dose Expansion Cohorts 10 to 12: Overall Survival (OS)	OS is defined as time from first study treatment to death due to any cause.	Up to approximately 6 months after the first dose date of last participant in Cohorts 10 to 12

Collaborators and Investigators

• Sponsor: AbbVie
• Investigators: Study Director: ABBVIE INC., AbbVie

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start (Actual): February 21, 2019
• Primary Completion (Estimated): June 23, 2027
• Study Completion (Estimated): June 23, 2027

Study Registration Dates

• First Submitted: January 28, 2019
• First Submitted That Met QC Criteria: January 28, 2019
• First Posted (Actual): January 30, 2019

Study Record Updates

• Last Update Posted (Actual): April 22, 2024
• Last Update Submitted That Met QC Criteria: April 18, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: pancreatic adenocarcinoma; cancer; Colorectal cancer; combination therapy; urothelial cancer; metastatic; Solid Tumors; Advanced Solid Tumors Cancer; monotherapy; triple negative breast cancer (TNBC); hepatocellular carcinoma (HCC); head and neck squamous cell carcinoma (HNSCC); Ovarian granulosa cell tumors
• Additional Relevant MeSH Terms: Neoplasms
• Other Study ID Numbers: M19-345; 2023-508281-15-00 (Other Identifier: EU CT)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes