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Phase 2 Futibatinib in Combination With PD-1 Antibody Based Standard of Care in Solid Tumors

StatusActive, Not Recruiting
PhasePhase 2
Started2023-07-13
View on ClinicalTrials.gov ↗
Record status
This record was last updated September 1, 2026 (before its estimated October 1, 2026 completion). Its status may not reflect the trial's current state.
Trial flagged as At Risk
Primary completion moved at least 8 months later Jan 28, 2026 → Oct 1, 2026
See other at-risk trials from Taiho Oncology, Inc.

Amendment history

2026-08-31
Study Status v16
Primary completion pushed: 2026-01-28 → 2026-10-01
2026-04-08
Study Status v15
Primary completion moved earlier: 2026-03 → 2026-01-28
2025-12-24
2 amendments v13-v14
2 re-verifications since 2025-12-04, no change to tracked fields
2025-09-03
Study Status v12
Primary completion date2025-07-21→2026-03
2025-05-30
Study Status v11
Re-verified, no change to tracked fields
Show 10 earlier versions
2025-04-30
Study Status, Study Design v10
Enrollment targetestimated 66→confirmed 53
2025-03-05
Recruiting→Active, Not Recruiting Study Status, Contacts/Locations v9
Trial statusRecruiting→Active, Not Recruiting
Primary completion date2025-01→2025-07-21
Completion date2025-05→2027-01
Study sitesdetails revised at 22 of 22 sites
2025-01-05
Study Status v8
Re-verified, no change to tracked fields
2024-11-29
Study Status, Contacts/Locations v7
Study sitesdetails revised at 1 of 22 sites
2024-08-30
Study Status, Contacts/Locations v6
Study sitesdetails revised at 17 of 22 sites
2024-06-25
Study Status, Contacts/Locations v5
Re-verified, no change to tracked fields
2024-02-23
Study Status, Study Description, Conditions, Study Design, Arms and Interventions, Eligibility v4
Enrollment target26→66
Study arms1→2
Eligibility criteria-2 characters
Inclusion Criteria:criteria Is ≥18 years of age at the time of informed consent Cohort [...] function Able to take medications orally Exclusion Criteria: Has locally advanced disease that is resectable or potentia [...]
Study description-34 characters
[...] or mFOLFOX6), patients with PDAC will receive mFOLFIRINOX. TheSubjects will receive futibatinib in combination with pembrolizumab plus standard of care (SOC) chemotherapy during induction phase of the study and will begincontinue on futibatinib in combination with a safety lead-in period (Part 1),pembrolizumab in whichconsolidation up to 18 patients (Cohort A = up to12, Cohort B = 6 ) will be enrolledphase. In Part 2, up to 54 patients (Cohort A = up to 20, Cohort B = 34) will be enrolled and treated with the same treatment regimens.
2024-01-23
Study Status, Contacts/Locations v3
Study sites1→22
2024-01-10
Study Status, Study Description, Conditions, Arms and Interventions, Eligibility v2
Interventions5-FU (Drug), Cisplatin (Drug), Futibatinib (Drug), Leucovorin (Drug), Levoleucovorin (Drug), Oxaliplatin (Drug), Pembrolizumab (Drug)→5-FU (Drug), Cisplatin (Drug), Futibatinib (Drug), Irinotecan (Drug), Leucovorin (Drug), Levoleucovorin (Drug), Oxaliplatin (Drug)…
Eligibility criteria+75 characters
Inclusion Criteria: Is ≥18 years of age at the time of informed consent Cohort A: Histologically or cytologically confirmed, locally advanced, [...] ype 1 adenocarcinoma of the esophagogastric junction (EGJ). Cohort B: Histologically or cytologically confirmed, locally advanced, unresectable or metastatic pancreatic ductal adenocarcinoma. No prior systemic treatment for locally advanced, unresectable or metastatic esophageal carcinoma.disease Measurable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST) guidelines. Have documentation of PD-L1 CPS score. Eastern Cooperative On [...] [...]
Study description+164 characters
Patients with locally advanced, unresectable or metastatic esophageal cancer (EC) or pancreatic ductal adenocarcinoma (PDAC) will receive futibatinib in combination with pembrolizumab plus standard of care (SOC) chemotherapy. Patients with EC will receive Investigator choice of chemotherapy (FP or mFOLFOX6), patients with PDAC will receive mFOLFIRINOX. The study will begin with a safety lead-in period (Part 1), in which approximatelyup 12to 18 patients with(Cohort advancedA or= metastaticup esophagealto12, cancerCohort B = 6 ) will be enrolled. In Part 2, approximatelyup 14to EC54 patients (Co [...] [...]
2023-08-04
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v1
Trial statusNot Yet Recruiting→Recruiting
Start dateestimated 2023-07→confirmed 2023-07-13
Study sites0→1
2023-07-06
Original filing
This is a nonrandomized, uncontrolled, open-label, multicenter Phase 2 study to evaluate the efficacy, safety, and tolerability of futibatinib in combination with PD-1 antibody-based SoC therapy in adult patients with solid tumors.
Trial Details
NCT Number NCT05945823
Lead Sponsor Taiho Oncology, Inc.
Conditions Locally Advanced Unresectable or Metastatic Solid Tumors Including Esophageal Cancer, Esophageal Adenocarcinoma, Esophageal Squamous Cell Cancer, Siewert Type 1 GEJ Cancer, Pancreatic Cancer
Enrollment 53 participants
Start Date 2023-07-13
Primary Completion 2026-10-01 (estimated)
Study Completion 2027-01 (estimated)
Updated on ClinicalTrials.gov 2026-09-01