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PFESeagen, a wholly owned subsidiary of PfizerRunning, no new patients

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

Colorectal Carcinoma · Gastric Adenocarcinoma · GEJ Adenocarcinoma · Esophageal Adenocarcinoma · Cholangiocarcinoma · Gallbladder Carcinoma

0Calmworry score, out of 100

No strong warning signs right now. The score counts warning signs; it is not a prediction.

Why this score

No warning signs right now. That's why the score is 0.

Score over time

Stage
Phase 2
Patients
40 (final count)
Started
Sep 15, 2020
Main results expected
Jul 31, 2024
Fully finished
Dec 31, 2026
Results posted
Sep 9, 2025

What counts as success

The trial's main goal(s), called the “primary outcome.”

  • Number of Participants With Renal Dose-Limiting Toxicities (DLTs): Phase 1b (Cohort 1A and 1B)

    Measured over: 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 over: 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 over: 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 over: 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 over: 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 over: 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 over: 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)

Changes Tremor has spotted

No changes since Tremor started watching this trial.
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Trial ID NCT04430738 · record last updated 2026-02-24 · checked 2026-11-09 15:47 UTC

See the official record on ClinicalTrials.gov (NCT04430738) ↗

Measured over: Cycle 1 (Up to 21 days)

  • Number of Participants With DLTs: Phase 1b (Cohort 1F)

    Measured over: Cycle 1 (Up to 28 days)

  • Number of Participants With Treatment Emergent Hematological Laboratory Abnormalities: Phase 1b (Cohort 1E and 1F)

    Measured over: 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 over: 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 over: 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 over: 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 over: 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 over: 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 over: 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 over: 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 over: 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 over: Cycle 1 (Up to 28 days)

  • Number of Participants With Treatment Emergent Hematological Laboratory Abnormalities: Phase 1b (Cohort 1D)

    Measured over: 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 over: 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 over: 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 over: 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 over: 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 over: 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 over: 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 over: 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 over: 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 over: 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 over: 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 over: 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 over: 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 over: 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 over: 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)