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Clinical Trials in Germany / NCT05945823
Active, not recruiting Phase 2

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

NCT05945823 · tracked via the Priya Life Science Germany tracker
Phase
Phase 2
Started
2023-07-13
Last updated
2026-09-01

Condition(s) studied

Locally Advanced Unresectable or Metastatic Solid Tumors Including Esophageal CancerEsophageal AdenocarcinomaEsophageal Squamous Cell CancerSiewert Type 1 GEJ CancerPancreatic Cancer

Investigational drug(s) / intervention(s)

Futibatinib →Pembrolizumab →Cisplatin →5-FU →Oxaliplatin →Leucovorin →Levoleucovorin →Irinotecan →

Futibatinib: TAS-120 20 mg tablets, oral; once daily

Pembrolizumab: 400 mg once every 6-week-cycle, via IV infusion.

Cisplatin: 80 mg/m\^2 Q3W via IV infusion, as part of investigator's choice FP chemotherapy

5-FU: 4000 mg/m\^2 Q3W via IV infusion, as part of investigator's choice FP chemotherapy or 400 mg/m\^2 Q2W via bolus IV infusion followed by 2400 mg/m\^2 Q2W via continuous IV infusion, as part of investigator's choice mFOLFOX6 chemotherapy. 2400 mg/m\^2 Q2W via continuous IV infusion, as part of investigator's choice mFOLFOX6 chemotherapy. 2400 mg/m\^2 Q2W via continuous IV infusion, as part of mFOLFIRINOX chemotherapy.

Oxaliplatin: 85 mg/m\^2 Q2W via IV infusion, as part of mFOLFIRINOX or mFOLFOX6 chemotherapy. 2400 mg/m\^2 Q2W via continuous IV infusion, as part of mFOLFIRINOX chemotherapy.

Leucovorin: 400 mg/m\^2 Q2W as part of mFOLFIRINOX or mFOLFOX6 chemotherapy.

Levoleucovorin: 200 mg/m\^2 Q2W as part of investigator's choice mFOLFOX6 chemotherapy.

Irinotecan: 150 mg/m\^2 Q2W as part of mFOLFIRINOX chemotherapy.

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion criteria 1. Is ≥18 years of age at the time of informed consent 2. Cohort A: Histologically or cytologically confirmed, locally advanced, unresectable or metastatic adenocarcinoma or squamous cell carcinoma of the esophagus or advanced/metastatic Siewert type 1 adenocarcinoma of the esophagogastric junction (EGJ). 3. Cohort B: Histologically or cytologically confirmed, locally advanced, unresectable or metastatic pancreatic ductal adenocarcinoma. 4. No prior systemic treatment for locally advanced, unresectable or metastatic disease 5. Measurable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST) guidelines. 6. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 7. Adequate organ function 8. Able to take medications orally Exclusion Criteria 1. Has locally advanced disease that is resectable or potentially curable with radiation therapy (as determined by local investigator). 2. Has an adenocarcinoma histology and is eligible to receive approved targeted therapy (eg, HER-2 positive patients). 3. Has received prior treatment with an anti-PD-1/PD-L1 or FGF/FGFR targeting drug, or any other agent directed to stimulatory or co-stimulatory T-cell receptor. 4. Has known additional malignancy that is progressing or requires active treatment. 5. History or current evidence of calcium and phosphate homeostasis disorder 6. Current evidence of clinically significant retinal disorder 7. Pregnant or lactating female. 8. Has known hypersensitivity or severe reaction to any of the study drugs or their excipients. 9. Has a diagnosis of immunodeficiency. 10. Has known human immunodeficiency virus (HIV) and/or history of Hepatitis B or C infections, or known to be positive for Hepatitis B antigen (HBsAg)/ Hepatitis B virus (HBV) DNA or Hepatitis C antibody or RNA. 11. Has an active autoimmune disease that has required systemic treatment in the past 2 years 12. Has a history of (noninfectious) pneumonitis that required steroids or has current pneumonitis. 13. Has had an allogenic tissue/organ transplant.

Primary outcome measure(s)

Trial sites (22)

FacilityCityRegionStatus
University of California Los Angeles UCLA - Cancer Care - Santa Monica Santa Monica California
Rocky Mountain Cancer Centers Midtown Denver Colorado
Mount Sinai Comprehensive Cancer Center Miami Beach Florida
Moffitt Cancer Center and Research Institute Tampa Florida
Henry Ford Health System Detroit Michigan
The Minniti Center - Medical Oncology and Hematology Mickleton New Jersey
Roswell Park Comprehensive Cancer Center (RPCCC) (Roswell Park Cancer Institute (RPCI)) Buffalo New York
NYU Langone New York New York
Gabrail Cancer Center Research LLC Canton Ohio
Alliance Cancer Specialists Horsham Pennsylvania
Vanderbilt University Medical Center Nashville Tennessee
Dallas VA Medical Center Dallas Texas
Inova Schar Cancer Institute Fairfax Virginia
Blue Ridge Cancer Care Roanoke Virginia
Virginia Mason Medical Center Seattle Washington
Gundersen Lutheran Health System La Crosse Wisconsin
Centre Hospitalier Regional Universitaire de Lille Lille France
Centre Hospitalier Regional Universitaire Poitiers Poitiers France
Krankenhaus Nordwest gGmbH Frankfurt Germany
Universitaetsmedizin Mainz Mainz Germany
Hospital Universitari Vall d'Hebron Barcelona Spain
Hospital Universitario 12 de Octubre Madrid Spain

On this site

📄 Keytruda (pembrolizumab) drug profile →

More Taiho Oncology, Inc. trials in Germany

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05945823 on ClinicalTrials.gov ↗ ← All trials in Germany