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

Source: https://onco.cc/trials/nct04430738/  
OnCo record `nct04430738` (Trial). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

A phase 2 trial of Tucatinib, Trastuzumab, CAPOX in gallbladder cancer, run by Seagen, a wholly owned subsidiary of Pfizer, active and no longer recruiting.

## Summary

Tucatinib Plus Trastuzumab and Oxaliplatin-based Chemotherapy or Pembrolizumab-containing Combinations for HER2+ Gastrointestinal Cancers is a phase 2 interventional study registered as NCT04430738 by Seagen, a wholly owned subsidiary of Pfizer, with 40 participants enrolled, started 2020-09-15 and due to reach its primary completion in 2024-07-31. Interventions recorded: tucatinib, trastuzumab, oxaliplatin, leucovorin, fluorouracil. Conditions listed: Colorectal Carcinoma, Gastric Adenocarcinoma, GEJ Adenocarcinoma, Esophageal Adenocarcinoma. Results were posted on ClinicalTrials.gov in 2025; the figures recorded here are the registry's, not a publication's.

## Fields

- Kind: Trial
- Status: active
- Last checked: 2026-09-22
- Tags: ctgov-ingest
- Registry id: NCT04430738
- Phase: 2
- Setting: 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
- Sponsor: Seagen, a wholly owned subsidiary of Pfizer
- Enrolled: 40
- Outcomes: Number of Participants With Renal Dose-Limiting Toxicities (DLTs): Phase 1b (Cohort 1A and 1B): Cohort 1A 0 participants vs Cohort 1B 1 participants

## Sources

- ClinicalTrials.gov NCT04430738: https://clinicaltrials.gov/study/NCT04430738

## Connected records

- cancers: [Gallbladder cancer](https://onco.cc/cancers/gallbladder/)
- technologies: [HER2 tyrosine kinase inhibitors](https://onco.cc/technologies/her2-tyrosine-kinase-inhibitors/), [Monoclonal antibodies](https://onco.cc/technologies/monoclonal-antibody/), [Small-molecule kinase inhibitors](https://onco.cc/technologies/kinase-inhibitors/)
- drugs: [Capecitabine](https://onco.cc/drugs/capecitabine/), [CAPOX (capecitabine, oxaliplatin)](https://onco.cc/drugs/capox/), [FLOT (5-FU, leucovorin, oxaliplatin, docetaxel)](https://onco.cc/drugs/flot/), [Fluorouracil (5-FU)](https://onco.cc/drugs/fluorouracil/), [Trastuzumab](https://onco.cc/drugs/trastuzumab/), [Tucatinib](https://onco.cc/drugs/tucatinib/)
- companies: [Pfizer (incl. Seagen)](https://onco.cc/companies/pfizer/)

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