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 : March 7, 2023

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View this study on Beta.ClinicalTrials.gov

Sponsor:

Information provided by (Responsible Party):

Seagen Inc.

Study Description

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

Study Design

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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

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Cholangiocarcinoma

Drug Information available for: Oxaliplatin Trastuzumab Tucatinib Pembrolizumab

Genetic and Rare Diseases Information Center resources: Esophageal Cancer Stomach Cancer Bile Duct Cancer Gallbladder Cancer

U.S. FDA Resources

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures :

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

Secondary Outcome Measures :

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.
Incidence of laboratory abnormalities (Cohorts 1A and 1B) [ Time Frame: 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
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
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
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
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
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
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
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
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)
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.
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.
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
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.

Eligibility Criteria

Information from the National Library of Medicine

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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.

Contacts and Locations

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

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Contact: Seagen Trial Information Support	8663337436	clinicaltrials@seagen.com

Locations

Show 21 study locations

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United States, Arizona
Mayo Clinic Arizona	Recruiting
Phoenix, Arizona, United States, 85054
Contact: Mayo Clinic Arizona Clinical Trials Referral Office Inbox 855-776-0015
Contact: Raquel Hawkins 480-574-2602 hawkins.raquel@mayo.edu
Principal Investigator: Tanios Bekaii-Saab
United States, California
Stanford University School of Medicine	Completed
Stanford, California, United States, 94305
United States, Colorado
University of Colorado Hospital / University of Colorado	Recruiting
Aurora, Colorado, United States, 80045
Contact: Matthew Lee 720-848-0300 matthew.r.lee@cuanschutz.edu
Principal Investigator: Sunnie Kim
SCL Health Good Samaritan Medical Center Cancer Centers of Colorado	Completed
Lafayette, Colorado, United States, 80026
United States, District of Columbia
Johns Hopkins Medical Center	Recruiting
Washington, District of Columbia, United States, 20016
Contact: Carol Goldener 220-660-6500 cgolden9@jhmi.edu
Contact: Kai Hajos 202-660-6791 khajos1@jhmi.edu
Principal Investigator: Michael Pishvaian
United States, Florida
H. Lee Moffitt Cancer Center and Research Institute	Completed
Tampa, Florida, United States, 33612
United States, Illinois
University of Chicago Medical Center	Recruiting
Chicago, Illinois, United States, 60637
Contact: Alex (Ryan) El-Naggar 773-702-7763 relnaggar@medicine.bsd.uchicago.edu
Principal Investigator: Chih-Yi Liao
United States, Minnesota
Mayo Clinic Rochester	Completed
Rochester, Minnesota, United States, 55903
United States, Missouri
Washington University in St Louis	Recruiting
Saint Louis, Missouri, United States, 63110
Contact: Jordan Wynn 314-273-4913 wynn@wustl.edu
Contact: Patrick Grierson (314) 362-5740 grierson@wustl.edu
Principal Investigator: Patrick Grierson
United States, New Mexico
University of New Mexico Cancer Center	Recruiting
Albuquerque, New Mexico, United States, 87131
Principal Investigator: Ursa Brown-Glaberman
United States, North Carolina
Levine Cancer Institute	Recruiting
Charlotte, North Carolina, United States, 28204
Contact: Melani Terry 980-442-2000 Melani.terry@atriumhealth.org
Principal Investigator: Mohamed Salem, MD
Duke University Medical Center	Recruiting
Durham, North Carolina, United States, 27710
Contact: Sabina Wlazlo Cascalherio 919-613-4812 sabina.wlazlo@duke.edu
Principal Investigator: John Strickler
United States, Ohio
Gabrail Cancer Center Research, LLC	Completed
Canton, Ohio, United States, 44718
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
Contact: Madilyn Heit 206-606-6387 mheit@seattlecca.org
Principal Investigator: David Zhen
Japan
National Cancer Center Hospital	Recruiting
Chuo-ku, Other, Japan, 104-0045
Principal Investigator: Satoru Iwasa
National Cancer Center Hospital East	Recruiting
Kashiwa-shi, Other, Japan, 277-8577
Principal Investigator: Kohei Shitara
St. Marianna University School of Medicine	Recruiting
Kawasaki-shi, Other, Japan, 2168511
Principal Investigator: Yu Sunakawa
The Cancer Institute Hospital of Japanese Foundation for Cancer Research	Recruiting
Koto-ku, Other, Japan, 135-8550
Principal Investigator: Kensei Yamaguchi
Aichi Cancer Center	Recruiting
Nagoya-shi, Other, Japan, 464-8681
Principal Investigator: Kei Muro
Osaka International Cancer Institute	Recruiting
Osaka, Other, Japan, 541-8567
Principal Investigator: Naotoshi Sugimoto

Sponsors and Collaborators

Seagen Inc.

Investigators

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Study Director:	JoAl Mayor, PharmD, BCOP	Seagen Inc.

More Information

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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:	March 7, 2023
Last Verified:	March 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:	No

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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:

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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 Pembrolizumab Trastuzumab Fluorouracil Capecitabine Oxaliplatin Tucatinib Antineoplastic Agents, Immunological Antineoplastic Agents Antimetabolites Molecular Mechanisms of Pharmacological Action Antimetabolites, Antineoplastic Immunosuppressive Agents Immunologic Factors

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