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

Running, not enrolling · Phase 2

Conditions studied: Colorectal Carcinoma, Gastric Adenocarcinoma, GEJ Adenocarcinoma, Esophageal Adenocarcinoma, Cholangiocarcinoma, Gallbladder Carcinoma

In brief

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).

Key facts

Study ID

NCT04430738

Run by

Seagen, a wholly owned subsidiary of Pfizer

People needed

40

Starts

2020-09-15

Expected to finish

2026-12-31

Last updated by the study team

2026-02-24

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Mayo Clinic Hospital — Phoenix, Arizona, United States
• Mayo Clinic — Scottsdale, Arizona, United States
• University of Colorado Denver CTO(CTRC) — Aurora, Colorado, United States
• University of Colorado Hospital - Anschutz Cancer Pavilion (ACP) — Aurora, Colorado, United States
• University of Colorado Hospital - Anschutz Inpatient Pavilion (AIP) — Aurora, Colorado, United States
• University of Colorado Hospital - Anschutz Outpatient Pavilion (AOP) — Aurora, Colorado, United States
• PCM Trials — Denver, Colorado, United States
• Sibley Memorial Hospital — Washington D.C., District of Columbia, United States
• Siteman Cancer Center - St Peters — City of Saint Peters, Missouri, United States
• Siteman Cancer Center - West County — Creve Coeur, Missouri, United States
• Siteman Cancer Center - North County — Florissant, Missouri, United States
• Siteman Cancer Center — St Louis, Missouri, United States
• Barnes-Jewish Hospital — St Louis, Missouri, United States
• Washington University School of Medicine — St Louis, Missouri, United States
• Siteman Cancer Center - South County — St Louis, Missouri, United States
• University of New Mexico Comprehensive Cancer Center — Albuquerque, New Mexico, United States
• Duke University Medical Center, Duke Cancer Center — Durham, North Carolina, United States
• Duke University Medical Center — Durham, North Carolina, United States
• Cleveland Clinic — Cleveland, Ohio, United States
• Fred Hutchinson Cancer Center — Seattle, Washington, United States
• University of Washington Medical Center — Seattle, Washington, United States
• Aichi Cancer Center Hospital — Nagoya, Aichi-ken, Japan
• National Cancer Center Hospital East — Kashiwa-shi, Chiba, Japan
• St. Marianna University Hospital — Kawasaki, Kanagawa, Japan
• Osaka International Cancer Institute — Osaka, Osaka, Japan

Full record on ClinicalTrials.gov

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