Tucatinib Plus Trastuzumab and Oxaliplatin-based Chemotherapy or Pembrolizumab-containing Combinations for HER2+ Gastrointestinal Cancers
Public ClinicalTrials.gov record NCT04430738. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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).
Study identification
- NCT ID
- NCT04430738
- Recruitment status
- Active, not recruiting
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 40 participants
Conditions and interventions
Conditions
Interventions
- tucatinib Drug
- trastuzumab Drug
- oxaliplatin Drug
- leucovorin Drug
- fluorouracil Drug
- capecitabine Drug
- pembrolizumab Drug
Drug
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Sep 15, 2020 (Actual)
- Primary completion
- Jul 31, 2024 (Actual)
- Completion
- Dec 31, 2026 (Estimated)
- Last update posted
- Feb 24, 2026
2020 – 2026
United States locations
- U.S. sites
- 21
- U.S. states
- 8
- U.S. cities
- 13
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Mayo Clinic Hospital | Phoenix | Arizona | 85054 | — |
| Mayo Clinic | Scottsdale | Arizona | 85259 | — |
| University of Colorado Denver CTO(CTRC) | Aurora | Colorado | 80045 | — |
| University of Colorado Hospital - Anschutz Cancer Pavilion (ACP) | Aurora | Colorado | 80045 | — |
| University of Colorado Hospital - Anschutz Inpatient Pavilion (AIP) | Aurora | Colorado | 80045 | — |
| University of Colorado Hospital - Anschutz Outpatient Pavilion (AOP) | Aurora | Colorado | 80045 | — |
| PCM Trials | Denver | Colorado | 80218 | — |
| Sibley Memorial Hospital | Washington D.C. | District of Columbia | 20016 | — |
| Siteman Cancer Center - St Peters | City of Saint Peters | Missouri | 63376 | — |
| Siteman Cancer Center - West County | Creve Coeur | Missouri | 63141 | — |
| Siteman Cancer Center - North County | Florissant | Missouri | 63031 | — |
| Siteman Cancer Center | St Louis | Missouri | 63108 | — |
| Barnes-Jewish Hospital | St Louis | Missouri | 63110 | — |
| Washington University School of Medicine | St Louis | Missouri | 63110 | — |
| Siteman Cancer Center - South County | St Louis | Missouri | 63129 | — |
| University of New Mexico Comprehensive Cancer Center | Albuquerque | New Mexico | 87131 | — |
| Duke University Medical Center, Duke Cancer Center | Durham | North Carolina | 27710 | — |
| Duke University Medical Center | Durham | North Carolina | 27710 | — |
| Cleveland Clinic | Cleveland | Ohio | 44195 | — |
| Fred Hutchinson Cancer Center | Seattle | Washington | 98109 | — |
| University of Washington Medical Center | Seattle | Washington | 98195 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 6 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04430738, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Feb 24, 2026 · Synced Oct 25, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT04430738 live on ClinicalTrials.gov.