Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04430738
Recruitment Status : Recruiting
First Posted : June 12, 2020
Last Update Posted : October 15, 2021
Sponsor:
Information provided by (Responsible Party):
Seagen Inc.

Brief Summary:

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).


Condition or disease Intervention/treatment Phase
Colorectal Carcinoma Gastric Adenocarcinoma GEJ Adenocarcinoma Esophageal Adenocarcinoma Cholangiocarcinoma Gallbladder Carcinoma Drug: tucatinib Drug: trastuzumab Drug: oxaliplatin Drug: leucovorin Drug: fluorouracil Drug: capecitabine Drug: pembrolizumab Phase 1 Phase 2

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : September 15, 2020
Estimated Primary Completion Date : May 30, 2024
Estimated Study Completion Date : October 31, 2025


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 Name: 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 Name: 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 Name: 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 Name: 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 Name: 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 Name: 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 Name: 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 Name: 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 Name: 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 Name: 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 Name: 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 Name: 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 Name: 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.




Primary Outcome Measures :
  1. 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) ]
  2. 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.

  3. Incidence of laboratory abnormalities (Cohorts 1C, 1D, 1E, 1F, 1G, 2A, and 2B) [ Time Frame: Up to approximately 12 months ]
  4. Incidence of DLTs (Cohorts 1C, 1D, 1E, 1F, and 1G) [ Time Frame: Up to approximately 12 months ]
  5. Incidence of dose alterations (Cohort 1D) [ Time Frame: Up to approximately 12 months ]

Secondary Outcome Measures :
  1. 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.

  2. Incidence of laboratory abnormalities (Cohorts 1A and 1B) [ Time Frame: Up to approximately 12 months ]
  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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

  9. 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

  10. 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

  11. 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)

  12. 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.

  13. 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.

  14. 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

  15. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04430738


Contacts
Layout table for location contacts
Contact: Seagen Trial Information Support 8663337436 clinicaltrials@seagen.com

Locations
Layout table for location information
United States, Arizona
Mayo Clinic Arizona Recruiting
Phoenix, Arizona, United States, 85054
Contact: Mayo Clinic Clinical Trials Referral Office Inbox    855-776-0015      
Principal Investigator: Tanios Bekaii-Saab         
United States, California
Stanford University School of Medicine Recruiting
Stanford, California, United States, 94305
Contact: Smruti Rahalkar    650-498-5186      
Principal Investigator: James M Ford         
Principal Investigator: Christopher T Chen         
United States, Colorado
University of Colorado Hospital / University of Colorado Recruiting
Aurora, Colorado, United States, 80045
Contact: Matthew R Lee    720-848-0300    matthew.r.lee@cuanschutz.edu   
Principal Investigator: Sunnie Kim         
United States, District of Columbia
Johns Hopkins Medical Center Recruiting
Washington, District of Columbia, United States, 20016
Contact: Carol Goldener, RN    220-660-6500      
Principal Investigator: Michael Pishvaian         
United States, Illinois
University of Chicago Medical Center Recruiting
Chicago, Illinois, United States, 60637-1470
Contact: Alex (Ryan) El-Naggar    773-702-7763      
Principal Investigator: Daniel Catenacci         
United States, Missouri
Washington University in St Louis Recruiting
Saint Louis, Missouri, United States, 63110
Contact: Viktoriia Hicks    314-362-3515    viktoriia.hicks@wustl.edu   
Contact: Jesse Huffman    314-362-3515    jessehuffman@wustl.edu   
Principal Investigator: Haeseong Park, MD         
United States, North Carolina
Duke University Medical Center Recruiting
Durham, North Carolina, United States, 27710
Contact: Ireka Burrus    919-668-1861    ireka.burrus@duke.edu   
Principal Investigator: John H Strickler, MD         
United States, Ohio
Gabrail Cancer Center Research, LLC Recruiting
Canton, Ohio, United States, 44718
Contact: Carrie Smith    330-492-3345      
Principal Investigator: Nashat Gabrail         
Cleveland Clinic, The Recruiting
Cleveland, Ohio, United States, 44195
Contact: Suneel Kamath    216-445-9451    kamaths@ccf.org   
Principal Investigator: Suneel Kamath         
United States, Washington
Seattle Cancer Care Alliance / University of Washington Recruiting
Seattle, Washington, United States, 98109-1023
Contact: Sean Park    206-606-6439      
Principal Investigator: David B Zhen         
Sponsors and Collaborators
Seagen Inc.
Investigators
Layout table for investigator information
Study Director: JoAl Mayor, PharmD, BCOP Seagen Inc.
Layout table for additonal information
Responsible Party: Seagen Inc.
ClinicalTrials.gov Identifier: NCT04430738    
Other Study ID Numbers: SGNTUC-024
First Posted: June 12, 2020    Key Record Dates
Last Update Posted: October 15, 2021
Last Verified: October 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Seagen Inc.:
HER2+
HER2-positive
CRC
Gastric cancer
Esophageal cancer
Seattle Genetics
Additional relevant MeSH terms:
Layout table for MeSH terms
Carcinoma
Adenocarcinoma
Cholangiocarcinoma
Colorectal Neoplasms
Gastrointestinal Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Intestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Leucovorin
Fluorouracil
Capecitabine
Oxaliplatin
Pembrolizumab
Trastuzumab
Tucatinib
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Antineoplastic Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs