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New drug cocktail shows promise for Hard-to-Treat gut cancers

NCT ID NCT04430738

Disease control Sponsor: Seagen, a wholly owned subsidiary of Pfizer Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study is testing a drug called tucatinib combined with other cancer medicines (trastuzumab, chemotherapy, and pembrolizumab) in people with HER2-positive cancers of the digestive system. The main goals are to find safe doses and see what side effects occur. About 40 adults with advanced stomach, bowel, or gallbladder cancer are taking part.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

40 people

The number who actually took part.

Started

Sep 2020

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

Adenocarcinoma Of Esophagus cholangiocarcinoma colorectal carcinoma colorectal neoplasm esophageal adenocarcinoma Esophageal Neoplasms gallbladder carcinoma gallbladder neoplasm gastric adenocarcinoma gastric neoplasm gastroesophageal junction adenocarcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Cholangiocarcinoma Colorectal carcinoma Esophageal adenocarcinoma Gallbladder carcinoma Gastric adenocarcinoma Gej adenocarcinoma

Contacts and locations

Locations

  • Aichi Cancer Center Hospital

    Nagoya, Aichi-ken, 464-8681, Japan

  • Barnes-Jewish Hospital

    St Louis, Missouri, 63110, United States

  • Cancer Institute Hospital of Japanese Foundation for Cancer Research.

    Koto-ku, Tokyo, 135-8550, Japan

  • Cleveland Clinic

    Cleveland, Ohio, 44195, United States

  • Duke University Medical Center

    Durham, North Carolina, 27710, United States

  • Duke University Medical Center, Duke Cancer Center

    Durham, North Carolina, 27710, United States

  • Fred Hutchinson Cancer Center

    Seattle, Washington, 98109, United States

  • Mayo Clinic

    Scottsdale, Arizona, 85259, United States

  • Mayo Clinic Hospital

    Phoenix, Arizona, 85054, United States

  • National Cancer Center Hospital

    Chuo-ku, Tokyo, 104-0045, Japan

  • National Cancer Center Hospital East

    Kashiwa-shi, Chiba, 277-8577, Japan

  • Osaka International Cancer Institute

    Osaka, Osaka, 541-8567, Japan

  • PCM Trials

    Denver, Colorado, 80218, United States

  • Sibley Memorial Hospital

    Washington D.C., District of Columbia, 20016, United States

  • Siteman Cancer Center

    St Louis, Missouri, 63108, United States

  • Siteman Cancer Center - North County

    Florissant, Missouri, 63031, United States

  • Siteman Cancer Center - South County

    St Louis, Missouri, 63129, United States

  • Siteman Cancer Center - St Peters

    City of Saint Peters, Missouri, 63376, United States

  • Siteman Cancer Center - West County

    Creve Coeur, Missouri, 63141, United States

  • St. Marianna University Hospital

    Kawasaki, Kanagawa, 216-8511, Japan

  • University of Colorado Denver CTO(CTRC)

    Aurora, Colorado, 80045, United States

  • University of Colorado Hospital - Anschutz Cancer Pavilion (ACP)

    Aurora, Colorado, 80045, United States

  • University of Colorado Hospital - Anschutz Inpatient Pavilion (AIP)

    Aurora, Colorado, 80045, United States

  • University of Colorado Hospital - Anschutz Outpatient Pavilion (AOP)

    Aurora, Colorado, 80045, United States

  • University of New Mexico Comprehensive Cancer Center

    Albuquerque, New Mexico, 87131, United States

  • University of Washington Medical Center

    Seattle, Washington, 98195, United States

  • Washington University School of Medicine

    St Louis, Missouri, 63110, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.