Tucatinib Plus Trastuzumab and Oxaliplatin-based Chemotherapy or Pembrolizumab-containing Combinations for HER2+ Gastrointestinal Cancers

April 19, 2024 updated by: Seagen Inc.

A Phase 1b/2 Dose Escalation and Expansion Study of Tucatinib in Combination With Trastuzumab and Oxaliplatin-based Chemotherapy or Pembrolizumab-containing Combinations for HER2+ Gastrointestinal Cancers

This trial studies tucatinib to find out if it is safe when given with trastuzumab and other anti-cancer drugs (pembrolizumab, FOLFOX, and CAPOX). It will look at what side effects happen when participants take this combination of drugs. A side effect is anything the drug does other than treating cancer. It will also look at whether tucatinib works with these drugs to treat certain types of cancer.

The participants in this trial have HER2-positive (HER2+) cancer in their gut, stomach, intestines, or gallbladder (gastrointestinal cancer).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

120

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

  • Japan
    • Other
      • Chuo-ku, Other, Japan, 104-0045
        • Active, not recruiting
        • National Cancer Center Hospital
      • Kashiwa-shi, Other, Japan, 277-8577
        • Active, not recruiting
        • National Cancer Center Hospital East
      • Kawasaki-shi, Other, Japan, 2168511
        • Active, not recruiting
        • St. Marianna University School of Medicine
      • Koto-ku, Other, Japan, 135-8550
        • Active, not recruiting
        • The Cancer Institute Hospital of Japanese Foundation for Cancer Research
      • Nagoya-shi, Other, Japan, 464-8681
        • Recruiting
        • Aichi Cancer Center
        • Principal Investigator:
          • Kei Muro
      • Osaka, Other, Japan, 541-8567
        • Recruiting
        • Osaka International Cancer Institute
        • Principal Investigator:
          • Naotoshi Sugimoto
      • Osakasayama-Shi, Other, Japan, 589-8511
        • Completed
        • Kindai University Hospital
  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85054
        • Active, not recruiting
        • Mayo Clinic Arizona
    • California
      • Palo Alto, California, United States, 94304
        • Completed
        • Stanford Cancer Center / Blood and Marrow Transplant Program
    • Colorado
      • Aurora, Colorado, United States, 80045
        • Active, not recruiting
        • University of Colorado Hospital / University of Colorado
      • Lafayette, Colorado, United States, 80026
        • Completed
        • SCL Health Good Samaritan Medical Center Cancer Centers of Colorado
    • District of Columbia
      • Washington, District of Columbia, United States, 20016
        • Recruiting
        • Johns Hopkins Medical Center
        • Principal Investigator:
          • Michael Pishvaian
        • Contact:
    • Florida
      • Tampa, Florida, United States, 33612
        • Completed
        • H. Lee Moffitt Cancer Center and Research Institute
    • Illinois
      • Chicago, Illinois, United States, 60637-1470
        • Completed
        • University of Chicago Medical Center
    • Minnesota
      • Rochester, Minnesota, United States, 55903-4008
        • Completed
        • Mayo Clinic Rochester
    • Missouri
      • Saint Louis, Missouri, United States, 63110
        • Recruiting
        • Washington University in St Louis
        • Principal Investigator:
          • Patrick Grierson
        • Contact:
    • New Mexico
      • Albuquerque, New Mexico, United States, 87131
        • Recruiting
        • New Mexico Cancer Center
        • Principal Investigator:
          • Erika Maestas, MD
    • North Carolina
      • Charlotte, North Carolina, United States, 28204
        • Recruiting
        • Levine Cancer Institute
        • Contact:
        • Principal Investigator:
          • Mohamed E Salem, MD
      • Durham, North Carolina, United States, 27710
        • Active, not recruiting
        • Duke University Medical Center
    • Ohio
      • Canton, Ohio, United States, 44718
        • Completed
        • Gabrail Cancer Center Research, LLC
      • Cleveland, Ohio, United States, 44195
        • Active, not recruiting
        • Cleveland Clinic, The
    • Washington
      • Seattle, Washington, United States, 98109-1023
        • Recruiting
        • Fred Hutchinson Cancer Center / Seattle Cancer Care Alliance / University of Washington
        • Contact:
        • Principal Investigator:
          • David B Zhen

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Participants must have an unresectable or metastatic solid malignancy that is histologically or cytologically confirmed to be one of the tumor types listed below:

    • Cohorts 1A, 1B, 1C, and 1D

      • CRC
      • Gastric adenocarcinoma
      • GEJ adenocarcinoma
      • Esophageal adenocarcinoma
      • Cholangiocarcinoma
      • Gallbladder carcinoma

    • Cohorts 1E, 1F, 1G, and 2A

      • Gastric adenocarcinoma
      • GEJ adenocarcinoma
      • Esophageal adenocarcinoma

    • Cohort 2B

      • CRC
  • Participants must be candidates to receive an oxaliplatin-based regimen as part of their standard-of-care treatment for all cohorts, except Cohort 1G.
  • HER2+ disease, as determined by historic or local laboratory testing
  • Phase 1b cohorts: measurable or non-measurable disease according to RECIST v1.1 as determined by the investigator
  • Phase 2 cohorts: measurable disease according to RECIST v1.1 as determined by the investigator
  • Eastern Cooperative Oncology Group Performance Status score of 0 or 1.

Exclusion Criteria:

  • History of known hypersensitivity to planned study treatment
  • Known to be positive for Hepatitis B or C
  • For Cohorts 2A and 2B: prior anti-HER2 therapies
  • For Cohorts 1E, 1F, 1G, 2A: Prior therapy with an anti-PD-1, anti-PD-L1, or anti PD L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (eg, CTLA-4, OX 40, CD137), and was discontinued from that treatment due to a Grade 3 or higher immune-related adverse event (irAE)

There are additional inclusion criteria. The study center will determine if criteria for participations are met.

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: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Cohort 1A
Tucatinib + trastuzumab + FOLFOX given in 14-day cycles
Drug: tucatinib
For Cohort 1A, 150 mg will be administered twice daily by mouth (orally) from Cycle 1 Day 8 onwards. For all other cohorts, 300 mg (or intermediate dose) will be given orally twice daily starting on Cycle 1 Day 1.
Other Names:
  • TUKYSA
Drug: trastuzumab
Cohorts 1A and 1B: a 6 mg/kg loading dose will be given into the vein (IV; intravenously) on Cycle 1 Day 1, followed by a dose of 4 mg/kg IV every 2 weeks starting on Cycle 2 Day 1. Cohorts 1C, 1D, 1E, 1F, 1G, 2A, and 2B: an 8 mg/kg loading dose will be administered IV on Cycle 1 Day 1, followed by a dose of 6 mg/kg IV every 3 weeks thereafter.
Drug: oxaliplatin
85 mg/m^2 given IV every 2 weeks for cohorts using FOLFOX. For cohorts using CAPOX regimen, 130 mg/m^2 given every 3 weeks.
Drug: leucovorin
200 (mFOLFOX7) or 400 (mFOLFOX6) mg/m^2 given IV every 2 weeks. Part of FOLFOX regimen.
Drug: fluorouracil
400 mg/m^2 (IV bolus after leucovorin) and/or 2400 mg/m^2 (continuous infusion over 46 hours). Part of FOLFOX regimen.
Experimental: Cohort 1B
Tucatinib + trastuzumab + FOLFOX given in 14-day cycles
Drug: tucatinib
For Cohort 1A, 150 mg will be administered twice daily by mouth (orally) from Cycle 1 Day 8 onwards. For all other cohorts, 300 mg (or intermediate dose) will be given orally twice daily starting on Cycle 1 Day 1.
Other Names:
  • TUKYSA
Drug: trastuzumab
Cohorts 1A and 1B: a 6 mg/kg loading dose will be given into the vein (IV; intravenously) on Cycle 1 Day 1, followed by a dose of 4 mg/kg IV every 2 weeks starting on Cycle 2 Day 1. Cohorts 1C, 1D, 1E, 1F, 1G, 2A, and 2B: an 8 mg/kg loading dose will be administered IV on Cycle 1 Day 1, followed by a dose of 6 mg/kg IV every 3 weeks thereafter.
Drug: oxaliplatin
85 mg/m^2 given IV every 2 weeks for cohorts using FOLFOX. For cohorts using CAPOX regimen, 130 mg/m^2 given every 3 weeks.
Drug: leucovorin
200 (mFOLFOX7) or 400 (mFOLFOX6) mg/m^2 given IV every 2 weeks. Part of FOLFOX regimen.
Drug: fluorouracil
400 mg/m^2 (IV bolus after leucovorin) and/or 2400 mg/m^2 (continuous infusion over 46 hours). Part of FOLFOX regimen.
Experimental: Cohort 1C
Tucatinib + trastuzumab + CAPOX given in 21-day cycles
Drug: tucatinib
For Cohort 1A, 150 mg will be administered twice daily by mouth (orally) from Cycle 1 Day 8 onwards. For all other cohorts, 300 mg (or intermediate dose) will be given orally twice daily starting on Cycle 1 Day 1.
Other Names:
  • TUKYSA
Drug: trastuzumab
Cohorts 1A and 1B: a 6 mg/kg loading dose will be given into the vein (IV; intravenously) on Cycle 1 Day 1, followed by a dose of 4 mg/kg IV every 2 weeks starting on Cycle 2 Day 1. Cohorts 1C, 1D, 1E, 1F, 1G, 2A, and 2B: an 8 mg/kg loading dose will be administered IV on Cycle 1 Day 1, followed by a dose of 6 mg/kg IV every 3 weeks thereafter.
Drug: oxaliplatin
85 mg/m^2 given IV every 2 weeks for cohorts using FOLFOX. For cohorts using CAPOX regimen, 130 mg/m^2 given every 3 weeks.
Drug: capecitabine
1000 mg/m^2 is taken twice per day orally on Days 1-14 of each 3 week cycle. Part of CAPOX regimen.
Experimental: Cohort 1D
Tucatinib + trastuzumab + FOLFOX. Tucatinib and FOLFOX given in 14-day cycles and trastuzumab given every 21 days
Drug: tucatinib
For Cohort 1A, 150 mg will be administered twice daily by mouth (orally) from Cycle 1 Day 8 onwards. For all other cohorts, 300 mg (or intermediate dose) will be given orally twice daily starting on Cycle 1 Day 1.
Other Names:
  • TUKYSA
Drug: trastuzumab
Cohorts 1A and 1B: a 6 mg/kg loading dose will be given into the vein (IV; intravenously) on Cycle 1 Day 1, followed by a dose of 4 mg/kg IV every 2 weeks starting on Cycle 2 Day 1. Cohorts 1C, 1D, 1E, 1F, 1G, 2A, and 2B: an 8 mg/kg loading dose will be administered IV on Cycle 1 Day 1, followed by a dose of 6 mg/kg IV every 3 weeks thereafter.
Drug: oxaliplatin
85 mg/m^2 given IV every 2 weeks for cohorts using FOLFOX. For cohorts using CAPOX regimen, 130 mg/m^2 given every 3 weeks.
Drug: leucovorin
200 (mFOLFOX7) or 400 (mFOLFOX6) mg/m^2 given IV every 2 weeks. Part of FOLFOX regimen.
Drug: fluorouracil
400 mg/m^2 (IV bolus after leucovorin) and/or 2400 mg/m^2 (continuous infusion over 46 hours). Part of FOLFOX regimen.
Experimental: Cohort 1E
Tucatinib + trastuzumab + pembrolizumab + FOLFOX. Tucatinib and FOLFOX given in 14-day cycles, trastuzumab given in 21-day cycles, and pembrolizumab given in 42-day cycles
Drug: tucatinib
For Cohort 1A, 150 mg will be administered twice daily by mouth (orally) from Cycle 1 Day 8 onwards. For all other cohorts, 300 mg (or intermediate dose) will be given orally twice daily starting on Cycle 1 Day 1.
Other Names:
  • TUKYSA
Drug: trastuzumab
Cohorts 1A and 1B: a 6 mg/kg loading dose will be given into the vein (IV; intravenously) on Cycle 1 Day 1, followed by a dose of 4 mg/kg IV every 2 weeks starting on Cycle 2 Day 1. Cohorts 1C, 1D, 1E, 1F, 1G, 2A, and 2B: an 8 mg/kg loading dose will be administered IV on Cycle 1 Day 1, followed by a dose of 6 mg/kg IV every 3 weeks thereafter.
Drug: oxaliplatin
85 mg/m^2 given IV every 2 weeks for cohorts using FOLFOX. For cohorts using CAPOX regimen, 130 mg/m^2 given every 3 weeks.
Drug: leucovorin
200 (mFOLFOX7) or 400 (mFOLFOX6) mg/m^2 given IV every 2 weeks. Part of FOLFOX regimen.
Drug: fluorouracil
400 mg/m^2 (IV bolus after leucovorin) and/or 2400 mg/m^2 (continuous infusion over 46 hours). Part of FOLFOX regimen.
Drug: pembrolizumab
400 mg given by IV on day 1 of cycle 1, then every 6 weeks.
Other Names:
  • KEYTRUDA
Experimental: Cohort 1F
Tucatinib + trastuzumab + pembrolizumab + CAPOX. Tucatinib, trastuzumab, and CAPOX given in 21-day cycles and pembrolizumab given in 42-day cycles.
Drug: tucatinib
For Cohort 1A, 150 mg will be administered twice daily by mouth (orally) from Cycle 1 Day 8 onwards. For all other cohorts, 300 mg (or intermediate dose) will be given orally twice daily starting on Cycle 1 Day 1.
Other Names:
  • TUKYSA
Drug: trastuzumab
Cohorts 1A and 1B: a 6 mg/kg loading dose will be given into the vein (IV; intravenously) on Cycle 1 Day 1, followed by a dose of 4 mg/kg IV every 2 weeks starting on Cycle 2 Day 1. Cohorts 1C, 1D, 1E, 1F, 1G, 2A, and 2B: an 8 mg/kg loading dose will be administered IV on Cycle 1 Day 1, followed by a dose of 6 mg/kg IV every 3 weeks thereafter.
Drug: oxaliplatin
85 mg/m^2 given IV every 2 weeks for cohorts using FOLFOX. For cohorts using CAPOX regimen, 130 mg/m^2 given every 3 weeks.
Drug: capecitabine
1000 mg/m^2 is taken twice per day orally on Days 1-14 of each 3 week cycle. Part of CAPOX regimen.
Drug: pembrolizumab
400 mg given by IV on day 1 of cycle 1, then every 6 weeks.
Other Names:
  • KEYTRUDA
Experimental: Cohort 1G
Tucatinib + trastuzumab + pembrolizumab. Tucatinib and trastuzumab given in 21-day cycles and pembrolizumab given in 42-day cycles.
Drug: tucatinib
For Cohort 1A, 150 mg will be administered twice daily by mouth (orally) from Cycle 1 Day 8 onwards. For all other cohorts, 300 mg (or intermediate dose) will be given orally twice daily starting on Cycle 1 Day 1.
Other Names:
  • TUKYSA
Drug: trastuzumab
Cohorts 1A and 1B: a 6 mg/kg loading dose will be given into the vein (IV; intravenously) on Cycle 1 Day 1, followed by a dose of 4 mg/kg IV every 2 weeks starting on Cycle 2 Day 1. Cohorts 1C, 1D, 1E, 1F, 1G, 2A, and 2B: an 8 mg/kg loading dose will be administered IV on Cycle 1 Day 1, followed by a dose of 6 mg/kg IV every 3 weeks thereafter.
Drug: pembrolizumab
400 mg given by IV on day 1 of cycle 1, then every 6 weeks.
Other Names:
  • KEYTRUDA
Experimental: Cohort 2A
Tucatinib + trastuzumab + pembrolizumab + (FOLFOX or CAPOX). Either (1) tucatinib and FOLFOX given in 14-day cycles or (2) tucatinib and CAPOX given in 21-day cycles. Trastuzumab given in 21-day cycles and pembrolizumab given in 42-day cycles.
Drug: tucatinib
For Cohort 1A, 150 mg will be administered twice daily by mouth (orally) from Cycle 1 Day 8 onwards. For all other cohorts, 300 mg (or intermediate dose) will be given orally twice daily starting on Cycle 1 Day 1.
Other Names:
  • TUKYSA
Drug: trastuzumab
Cohorts 1A and 1B: a 6 mg/kg loading dose will be given into the vein (IV; intravenously) on Cycle 1 Day 1, followed by a dose of 4 mg/kg IV every 2 weeks starting on Cycle 2 Day 1. Cohorts 1C, 1D, 1E, 1F, 1G, 2A, and 2B: an 8 mg/kg loading dose will be administered IV on Cycle 1 Day 1, followed by a dose of 6 mg/kg IV every 3 weeks thereafter.
Drug: oxaliplatin
85 mg/m^2 given IV every 2 weeks for cohorts using FOLFOX. For cohorts using CAPOX regimen, 130 mg/m^2 given every 3 weeks.
Drug: leucovorin
200 (mFOLFOX7) or 400 (mFOLFOX6) mg/m^2 given IV every 2 weeks. Part of FOLFOX regimen.
Drug: fluorouracil
400 mg/m^2 (IV bolus after leucovorin) and/or 2400 mg/m^2 (continuous infusion over 46 hours). Part of FOLFOX regimen.
Drug: capecitabine
1000 mg/m^2 is taken twice per day orally on Days 1-14 of each 3 week cycle. Part of CAPOX regimen.
Drug: pembrolizumab
400 mg given by IV on day 1 of cycle 1, then every 6 weeks.
Other Names:
  • KEYTRUDA
Experimental: Cohort 2B
Tucatinib + trastuzumab + FOLFOX given in 14-day cycles.
Drug: tucatinib
For Cohort 1A, 150 mg will be administered twice daily by mouth (orally) from Cycle 1 Day 8 onwards. For all other cohorts, 300 mg (or intermediate dose) will be given orally twice daily starting on Cycle 1 Day 1.
Other Names:
  • TUKYSA
Drug: trastuzumab
Cohorts 1A and 1B: a 6 mg/kg loading dose will be given into the vein (IV; intravenously) on Cycle 1 Day 1, followed by a dose of 4 mg/kg IV every 2 weeks starting on Cycle 2 Day 1. Cohorts 1C, 1D, 1E, 1F, 1G, 2A, and 2B: an 8 mg/kg loading dose will be administered IV on Cycle 1 Day 1, followed by a dose of 6 mg/kg IV every 3 weeks thereafter.
Drug: oxaliplatin
85 mg/m^2 given IV every 2 weeks for cohorts using FOLFOX. For cohorts using CAPOX regimen, 130 mg/m^2 given every 3 weeks.
Drug: leucovorin
200 (mFOLFOX7) or 400 (mFOLFOX6) mg/m^2 given IV every 2 weeks. Part of FOLFOX regimen.
Drug: fluorouracil
400 mg/m^2 (IV bolus after leucovorin) and/or 2400 mg/m^2 (continuous infusion over 46 hours). Part of FOLFOX regimen.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of renal dose-limiting toxicities (DLTs) (Cohorts 1A and 1B)
Time Frame: Up to one month; 2 cycles after receiving all study treatment (each cycle is 14 days)
Up to one month; 2 cycles after receiving all study treatment (each cycle is 14 days)
Incidence of adverse events (AEs) (Cohorts 1C, 1D, 1E, 1F, 1G, 2A, and 2B)
Time Frame: Up to approximately 12 months
An AE is defined as any untoward medical occurrence in a clinical investigational participant administered a medicinal product and which does not necessarily have a causal relationship with this treatment.
Up to approximately 12 months
Incidence of laboratory abnormalities (Cohorts 1C, 1D, 1E, 1F, 1G, 2A, and 2B)
Time Frame: Up to approximately 12 months
Up to approximately 12 months
Incidence of DLTs (Cohorts 1C, 1D, 1E, 1F, and 1G)
Time Frame: Up to approximately 12 months
Up to approximately 12 months
Incidence of dose alterations (Cohort 1D)
Time Frame: Up to approximately 12 months
Up to approximately 12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of AEs (Cohorts 1A and 1B)
Time Frame: Up to approximately 12 months
An AE is defined as any untoward medical occurrence in a clinical investigational participant administered a medicinal product and which does not necessarily have a causal relationship with this treatment.
Up to approximately 12 months
Incidence of laboratory abnormalities (Cohorts 1A and 1B)
Time Frame: Up to approximately 12 months
Up to approximately 12 months
Change in glomerular filtration rate (GFR) from baseline through 2 cycles of combination therapy (Cohorts 1A and 1B)
Time Frame: Up to approximately 6 weeks
To be summarized using descriptive statistics
Up to approximately 6 weeks
Pharmacokinetic (PK) parameter of tucatinib - AUClast (Cohorts 1A and 1B)
Time Frame: Up to approximately 2.5 months; through predose of Cycle 2, Day 1 (each cycle is 14 days)
To be summarized using descriptive statistics
Up to approximately 2.5 months; through predose of Cycle 2, Day 1 (each cycle is 14 days)
PK parameter of tucatinib - Cmax (Cohorts 1A and 1B)
Time Frame: Up to approximately 2.5 months; through predose of Cycle 2, Day 1 (each cycle is 14 days)
To be summarized using descriptive statistics
Up to approximately 2.5 months; through predose of Cycle 2, Day 1 (each cycle is 14 days)
PK parameter of tucatinib - Ctrough (Cohorts 1A, 1B, 1C, 1E, 1F, and 1G)
Time Frame: Up to approximately 2.5 months; through predose of Cycle 6, Day 1
To be summarized using descriptive statistics
Up to approximately 2.5 months; through predose of Cycle 6, Day 1
PK parameter of tucatinib - Tmax (Cohorts 1A and 1B)
Time Frame: Up to approximately 2.5 months; through predose of Cycle 2, Day 1 (each cycle is 14 days)
To be summarized using descriptive statistics
Up to approximately 2.5 months; through predose of Cycle 2, Day 1 (each cycle is 14 days)
PK parameter of oxaliplatin - AUClast (Cohorts 1A and 1B)
Time Frame: Up to 15 days; through Cycle 2, Day 1 (each cycle is 14 days)
To be summarized using descriptive statistics
Up to 15 days; through Cycle 2, Day 1 (each cycle is 14 days)
PK parameter of oxaliplatin - Cmax (Cohorts 1A and 1B)
Time Frame: Up to 15 days; through Cycle 2, Day 1 (each cycle is 14 days)
To be summarized using descriptive statistics
Up to 15 days; through Cycle 2, Day 1 (each cycle is 14 days)
PK parameter of oxaliplatin - Tmax (Cohorts 1A and 1B)
Time Frame: Up to 15 days; through Cycle 2, Day 1 (each cycle is 14 days)
To be summarized using descriptive statistics
Up to 15 days; through Cycle 2, Day 1 (each cycle is 14 days)
Confirmed objective response rate (cORR) according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 per investigator assessment (INV) (Cohort 2A)
Time Frame: Up to approximately 2.5 years
cORR is defined as the proportion of participants with confirmed complete response (CR) or partial response (PR)
Up to approximately 2.5 years
Duration of response (DOR) according to RECIST v1.1 per INV (Cohorts 1C, 1E, 1F, 1G, and 2A)
Time Frame: Up to approximately 2.5 years
DOR is defined as the time from first documentation of objective response of confirmed CR or confirmed PR to the first documentation of disease progression or death from any cause, whichever occurs first.
Up to approximately 2.5 years
Progression-free survival (PFS) according to RECIST v1.1 per INV (Cohorts 1C, 1E, 1F, 1G, and 2A)
Time Frame: Up to approximately 2.5 years
PFS is defined as the time from the date of treatment initiation to the date of disease progression or death from any cause, which occurs first.
Up to approximately 2.5 years
Overall survival (OS) (Cohort 1C, 1E, 1F, 1G, and 2A)
Time Frame: Up to approximately 2.5 years
OS is defined as the time from treatment initiation to death due to any cause
Up to approximately 2.5 years
Objective response rate (ORR) (Cohorts 1C, 1E, 1F, and 1G)
Time Frame: Up to approximately 2.5 years
ORR is defined as the proportion of subjects with confirmed CR or PR, according to RECIST v1.1.
Up to approximately 2.5 years

Collaborators and Investigators

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

Sponsor

Seagen Inc.

Investigators

  • Study Director: Medical Monitor, Seagen Inc.

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)

September 15, 2020

Primary Completion (Estimated)

May 30, 2024

Study Completion (Estimated)

October 31, 2025

Study Registration Dates

First Submitted

June 10, 2020

First Submitted That Met QC Criteria

June 11, 2020

First Posted (Actual)

June 12, 2020

Study Record Updates

Last Update Posted (Actual)

April 23, 2024

Last Update Submitted That Met QC Criteria

April 19, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SGNTUC-024

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

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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