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ACTIVE NOT RECRUITING Phase 2

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

NCT05945823 · View on ClinicalTrials.gov ↗

Study Summary

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.

Interventions

  • DRUG Pembrolizumab
  • DRUG Cisplatin
  • DRUG Oxaliplatin
  • DRUG 5-FU
  • DRUG Futibatinib

Study Locations (20)

Other

  • Centre Hospitalier Regional Universitaire de Lille — Lille
  • Centre Hospitalier Regional Universitaire Poitiers — Poitiers
  • Krankenhaus Nordwest gGmbH — Frankfurt
  • Universitaetsmedizin Mainz — Mainz

Florida

  • Mount Sinai Comprehensive Cancer Center — Miami Beach
  • Moffitt Cancer Center and Research Institute — Tampa

New York

  • Roswell Park Comprehensive Cancer Center (RPCCC) (Roswell Park Cancer Institute (RPCI)) — Buffalo
  • NYU Langone — New York

Virginia

  • Inova Schar Cancer Institute — Fairfax
  • Blue Ridge Cancer Care — Roanoke

California

  • University of California Los Angeles UCLA - Cancer Care - Santa Monica — Santa Monica

Colorado

  • Rocky Mountain Cancer Centers Midtown — Denver

Michigan

  • Henry Ford Health System — Detroit

New Jersey

  • The Minniti Center - Medical Oncology and Hematology — Mickleton

Trial Details

FieldValue
Enrollment Target 53 participants
Start Date 2023-07-13
Est. Completion 2027-01
Phase Phase 2

Sponsor

Taiho Oncology

46 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT05945823

The ClinicalTrials.gov registry entry for NCT05945823 describes a study currently listed as active not recruiting. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 53 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Taiho Oncology, which has 46 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 5 conditions, with Pancreatic Cancer appearing as the primary indexed condition, and to 5 interventions — of which Pembrolizumab is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT05945823 reports 20 study locations spanning 14 distinct geographic areas — top geographies include Other, Florida, New York. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT05945823 about?

NCT05945823 is a clinical study titled "Phase 2 Futibatinib in Combination With PD-1 Antibody Based Standard of Care in Solid Tumors". 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.

What is the current status of trial NCT05945823?

This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 53 participants. The study started on 2023-07-13. Estimated completion is 2027-01.

What conditions does trial NCT05945823 study?

This clinical trial studies the following conditions: Pancreatic Cancer, Esophageal Adenocarcinoma, Esophageal Squamous Cell Cancer, Locally Advanced Unresectable or Metastatic Solid Tumors Including Esophageal Cancer, Siewert Type 1 GEJ Cancer. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT05945823?

The interventions under investigation include: Pembrolizumab (DRUG), Cisplatin (DRUG), Oxaliplatin (DRUG), 5-FU (DRUG), Futibatinib (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT05945823?

This trial is sponsored by Taiho Oncology, which has 46 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT05945823 being conducted?

This trial has 20 study locations across California, Colorado, Florida, Michigan, New Jersey. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial