Status:
ACTIVE_NOT_RECRUITING
Tucatinib Plus Trastuzumab and Oxaliplatin-based Chemotherapy or Pembrolizumab-containing Combinations for HER2+ Gastrointestinal Cancers
Lead Sponsor:
Seagen, a wholly owned subsidiary of Pfizer
Conditions:
Colorectal Carcinoma
Gastric Adenocarcinoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
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 partici...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 15 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2025
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT04430738
Start Date
September 15 2020
End Date
December 31 2025
Last Update
December 11 2025
Active Locations (27)
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1
Mayo Clinic Hospital
Phoenix, Arizona, United States, 85054
2
Mayo Clinic
Scottsdale, Arizona, United States, 85259
3
University of Colorado Denver CTO(CTRC)
Aurora, Colorado, United States, 80045
4
University of Colorado Hospital - Anschutz Cancer Pavilion (ACP)
Aurora, Colorado, United States, 80045