{"entity":{"id":"nct04430738","kind":"trial","name":"Tucatinib Plus Trastuzumab and Oxaliplatin-based Chemotherapy or Pembrolizumab-containing Combinations for HER2+ Gastrointestinal Cancers","aka":[],"tldr":"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.","status":"active","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT04430738","url":"https://clinicaltrials.gov/study/NCT04430738"}],"tags":["ctgov-ingest"],"related":[],"cancers":["gallbladder"],"sections":[],"technologies":["her2-tyrosine-kinase-inhibitors","kinase-inhibitors","monoclonal-antibody"],"targets":[],"drugs":["tucatinib","trastuzumab","capox","flot","fluorouracil","capecitabine"],"companies":["pfizer"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"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","started":"2020-09-15","startedType":"actual","yearReported":2025,"enrolled":40,"enrolledBasis":"registry","outcomes":[{"endpoint":"Number of Participants With Renal Dose-Limiting Toxicities (DLTs): Phase 1b (Cohort 1A and 1B)","primary":true,"unit":"participants","arms":[{"name":"Cohort 1A","n":3,"value":0,"note":"Figures from the ClinicalTrials.gov results section (first posted 2025-09-09), not from a publication"},{"name":"Cohort 1B","n":8,"value":1}],"source":"https://clinicaltrials.gov/study/NCT04430738?tab=results"}]},"route":"/trials/nct04430738/","neighbours":{"cancer":[{"id":"gallbladder","kind":"cancer","name":"Gallbladder cancer","route":"/cancers/gallbladder/"}],"technology":[{"id":"her2-tyrosine-kinase-inhibitors","kind":"technology","name":"HER2 tyrosine kinase inhibitors","route":"/technologies/her2-tyrosine-kinase-inhibitors/"},{"id":"monoclonal-antibody","kind":"technology","name":"Monoclonal antibodies","route":"/technologies/monoclonal-antibody/"},{"id":"kinase-inhibitors","kind":"technology","name":"Small-molecule kinase inhibitors","route":"/technologies/kinase-inhibitors/"}],"drug":[{"id":"capecitabine","kind":"drug","name":"Capecitabine","route":"/drugs/capecitabine/"},{"id":"capox","kind":"drug","name":"CAPOX (capecitabine, oxaliplatin)","route":"/drugs/capox/"},{"id":"flot","kind":"drug","name":"FLOT (5-FU, leucovorin, oxaliplatin, docetaxel)","route":"/drugs/flot/"},{"id":"fluorouracil","kind":"drug","name":"Fluorouracil (5-FU)","route":"/drugs/fluorouracil/"},{"id":"trastuzumab","kind":"drug","name":"Trastuzumab","route":"/drugs/trastuzumab/"},{"id":"tucatinib","kind":"drug","name":"Tucatinib","route":"/drugs/tucatinib/"}],"company":[{"id":"pfizer","kind":"company","name":"Pfizer (incl. Seagen)","route":"/companies/pfizer/"}]}}