Tucatinib Plus Trastuzumab and Oxaliplatin-based Chemotherapy or Pembrolizumab-containing Combinations for HER2+ Gastrointestinal Cancers
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Phase
Phase 2
Status
Active, not recruiting
Study type
Interventional
Design
Non randomized · None · Treatment
Enrollment
40actual
Sites
27
Countries
Japan, United States
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2020-09-15 | actual | When the study began enrolling |
| Primary completion | 2024-07-31 | actual | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2026-12-31 | estimated | The whole study's end, after follow-up |
| First posted | 2020-06-12 | actual | When this record first appeared on the registry |
| Results posted | 2025-09-09 | actual | When the sponsor posted results to the registry |
| Record updated | 2026-02-24 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Conditions
- Colorectal Carcinoma
- Gastric Adenocarcinoma
- GEJ Adenocarcinoma
- Esophageal Adenocarcinoma
- Cholangiocarcinoma
- Gallbladder Carcinoma
Interventions
- Drug: tucatinib — also filed as TUKYSA
- Drug: trastuzumab
- Drug: oxaliplatin
- Drug: leucovorin
- Drug: fluorouracil
- Drug: capecitabine
- Drug: pembrolizumab — also filed as KEYTRUDA
Primary outcomes
what the primary-completion date above is the date OFNumber of Participants With Renal Dose-Limiting Toxicities (DLTs): Phase 1b (Cohort 1A and 1B)
measured From first dose of tucatinib until end of Cycle 3 (up to 42 days)
Number of Participants With Treatment Emergent Adverse Events (TEAEs): Phase 1b (Cohort 1E and 1F)
measured From first dose of the study treatment (Day 1) up to 30 days after the last dose of study treatment, end of study date, death date, or data cutoff date, whichever was earlier (maximum of 20.7 months)
Number of Participants With Treatment Related TEAEs: Phase 1b (Cohort 1E and 1F)
measured From first dose of the study treatment (Day 1) up to 30 days after the last dose of study treatment, end of study date, death date, or data cutoff date, whichever was earlier (maximum of 20.7 months)
Number of Participants With Greater Than or Equal to (>=) Grade 3 TEAEs: Phase 1b (Cohort 1E and 1F)
measured From first dose of the study treatment (Day 1) up to 30 days after the last dose of study treatment, end of study date, death date, or data cutoff date, whichever was earlier (maximum of 20.7 months)
Number of Participants With >= Grade 3 Treatment Related TEAEs: Phase 1b (Cohort 1E and 1F)
measured From first dose of the study treatment (Day 1) up to 30 days after the last dose of study treatment, end of study date, death date, or data cutoff date, whichever was earlier (maximum of 20.7 months)
Number of Participants With Any Serious Adverse Event (SAE): Phase 1b (Cohort 1E and 1F)
measured From first dose of the study treatment (Day 1) up to 30 days after the last dose of study treatment, end of study date, death date, or data cutoff date, whichever was earlier (maximum of 20.7 months)
Number of Participants With Any Treatment Related SAE: Phase 1b (Cohort 1E and 1F)
measured From first dose of the study treatment (Day 1) up to 30 days after the last dose of study treatment, end of study date, death date, or data cutoff date, whichever was earlier (maximum of 20.7 months)
Number of Participants With DLTs: Phase 1b (Cohort 1E)
measured Cycle 1 (Up to 21 days)
Number of Participants With DLTs: Phase 1b (Cohort 1F)
measured Cycle 1 (Up to 28 days)
Number of Participants With Treatment Emergent Hematological Laboratory Abnormalities: Phase 1b (Cohort 1E and 1F)
measured From first dose of the study treatment (Day 1) up to 30 days after the last dose of study treatment, end of study date, death date, or data cutoff date, whichever was earlier (maximum of 20.7 months)
Number of Participants With Treatment Emergent Chemistry Laboratory Abnormalities: Phase 1b (Cohort 1E and 1F)
measured From first dose of the study treatment (Day 1) up to 30 days after the last dose of study treatment, end of study date, death date, or data cutoff date, whichever was earlier (maximum of 20.7 months)
Number of Participants With Clinically Significant Post-Baseline Vital Signs: Phase 1b (Cohort 1E and 1F)
measured From first dose of the study treatment (Day 1) up to 30 days after the last dose of study treatment, end of study date, death date, or data cutoff date, whichever was earlier (maximum of 20.7 months)
Number of Participants With TEAEs: Phase 1b (Cohort 1D)
measured From first dose of the study treatment (Day 1) up to 30 days after the last dose of study treatment, end of study date, death date, or data cutoff date, whichever was earlier (maximum of 21 months)
Number of Participants With Treatment Related TEAEs: Phase 1b (Cohort 1D)
measured From first dose of the study treatment (Day 1) up to 30 days after the last dose of study treatment, end of study date, death date, or data cutoff date, whichever was earlier (maximum of 21 months)
Number of Participants With >= Grade 3 TEAEs: Phase 1b (Cohort 1D)
measured From first dose of the study treatment (Day 1) up to 30 days after the last dose of study treatment, end of study date, death date, or data cutoff date, whichever was earlier (maximum of 21 months)
Number of Participants With >= Grade 3 Treatment Related TEAEs: Phase 1b (Cohort 1D)
measured From first dose of the study treatment (Day 1) up to 30 days after the last dose of study treatment, end of study date, death date, or data cutoff date, whichever was earlier (maximum of 21 months)
Number of Participants With Any SAE: Phase 1b (Cohort 1D)
measured From first dose of the study treatment (Day 1) up to 30 days after the last dose of study treatment, end of study date, death date, or data cutoff date, whichever was earlier (maximum of 21 months)
Number of Participants With Any Treatment Related SAE: Phase 1b (Cohort 1D)
measured From first dose of the study treatment (Day 1) up to 30 days after the last dose of study treatment, end of study date, death date, or data cutoff date, whichever was earlier (maximum of 21 months)
Number of Participants With DLTs: Phase 1b (Cohort 1D)
measured Cycle 1 (Up to 28 days)
Number of Participants With Treatment Emergent Hematological Laboratory Abnormalities: Phase 1b (Cohort 1D)
measured From first dose of the study treatment (Day 1) up to 30 days after the last dose of study treatment, end of study date, death date, or data cutoff date, whichever was earlier (maximum of 21 months)
Number of Participants With Treatment Emergent Chemistry Laboratory Abnormalities: Phase 1b (Cohort 1D)
measured From first dose of the study treatment (Day 1) up to 30 days after the last dose of study treatment, end of study date, death date, or data cutoff date, whichever was earlier (maximum of 21 months)
Number of Participants With Clinically Significant Post-Baseline Vital Signs: Phase 1b (Cohort 1D)
measured From first dose of the study treatment (Day 1) up to 30 days after the last dose of study treatment, end of study date, death date, or data cutoff date, whichever was earlier (maximum of 21 months)
Number of Participants With TEAEs Leading to Dose Holds: Phase 1b (Cohort 1D)
measured From first dose of the study treatment (Day 1) up to 30 days after the last dose of study treatment, end of study date, death date, or data cutoff date, whichever was earlier (maximum of 21 months)
Number of Participants With TEAEs Leading to Dose Reductions: Phase 1b (Cohort 1D)
measured From first dose of the study treatment (Day 1) up to 30 days after the last dose of study treatment, end of study date, death date, or data cutoff date, whichever was earlier (maximum of 21 months)
Number of Participants With TEAEs Leading to Dose Discontinuations: Phase 1b (Cohort 1D)
measured From first dose of the study treatment (Day 1) up to 30 days after the last dose of study treatment, end of study date, death date, or data cutoff date, whichever was earlier (maximum of 21 months)
Number of Participants With TEAEs: Phase 2 (Cohort 2B)
measured From first dose of the study treatment (Day 1) up to 30 days after the last dose of study treatment, end of study date, death date, or data cutoff date, whichever was earlier (maximum of 20.9 months)
Number of Participants With Treatment Related TEAEs: Phase 2 (Cohort 2B)
measured From first dose of the study treatment (Day 1) up to 30 days after the last dose of study treatment, end of study date, death date, or data cutoff date, whichever was earlier (maximum of 20.9 months)
Number of Participants With >= Grade 3 TEAEs: Phase 2 (Cohort 2B)
measured From first dose of the study treatment (Day 1) up to 30 days after the last dose of study treatment, end of study date, death date, or data cutoff date, whichever was earlier (maximum of 20.9 months)
Number of Participants With >= Grade 3 Treatment Related TEAEs: Phase 2 (Cohort 2B)
measured From first dose of the study treatment (Day 1) up to 30 days after the last dose of study treatment, end of study date, death date, or data cutoff date, whichever was earlier (maximum of 20.9 months)
Number of Participants With Any SAE: Phase 2 (Cohort 2B)
measured From first dose of the study treatment (Day 1) up to 30 days after the last dose of study treatment, end of study date, death date, or data cutoff date, whichever was earlier (maximum of 20.9 months)
Number of Participants With Any Treatment Related SAE: Phase 2 (Cohort 2B)
measured From first dose of the study treatment (Day 1) up to 30 days after the last dose of study treatment, end of study date, death date, or data cutoff date, whichever was earlier (maximum of 20.9 months)
Number of Participants With Treatment Emergent Hematological Laboratory Abnormalities: Phase 2 (Cohort 2B)
measured From first dose of the study treatment (Day 1) up to 30 days after the last dose of study treatment, end of study date, death date, or data cutoff date, whichever was earlier (maximum of 20.9 months)
Number of Participants With Treatment Emergent Chemistry Laboratory Abnormalities: Phase 2 (Cohort 2B)
measured From first dose of the study treatment (Day 1) up to 30 days after the last dose of study treatment, end of study date, death date, or data cutoff date, whichever was earlier (maximum of 20.9 months)
Number of Participants With Clinically Significant Post-Baseline Vital Signs: Phase 2 (Cohort 2B)
measured From first dose of the study treatment (Day 1) up to 30 days after the last dose of study treatment, end of study date, death date, or data cutoff date, whichever was earlier (maximum of 20.9 months)
Posted documents
hosted by the registry — we link, never re-serveStudy Protocolposted 2024-11-06 · 25.4 MB · Prot_000.pdf
Statistical Analysis Planposted 2024-04-29 · 3.0 MB · SAP_001.pdf
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