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

  • End date
    Oct 31, 2025
  • participants needed
  • sponsor
    Seagen Inc.
Updated on 13 October 2022
measurable disease
growth factor
gastric adenocarcinoma
esophageal adenocarcinoma
folfox regimen
gallbladder carcinoma


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 Colorectal Carcinoma, Gastric Adenocarcinoma, GEJ Adenocarcinoma, Esophageal Adenocarcinoma, Cholangiocarcinoma, Gallbladder Carcinoma
Treatment Capecitabine, fluorouracil, Trastuzumab, Pembrolizumab, Oxaliplatin, Leucovorin, Tucatinib
Clinical Study IdentifierNCT04430738
SponsorSeagen Inc.
Last Modified on13 October 2022


Yes No Not Sure

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
Gastric adenocarcinoma
GEJ adenocarcinoma
Esophageal adenocarcinoma
Gallbladder carcinoma
Cohorts 1E, 1F, 1G, and 2A
Gastric adenocarcinoma
GEJ adenocarcinoma
Esophageal adenocarcinoma
Cohort 2B
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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How to participate?

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What happens next?
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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