Phase 2 Futibatinib in Combination With PD-1 Antibody Based Standard of Care in Solid Tumors (NCT05945823) | Clinical Trial Compass
Active — Not RecruitingPhase 2
Phase 2 Futibatinib in Combination With PD-1 Antibody Based Standard of Care in Solid Tumors
United States53 participantsStarted 2023-07-13
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Is ≥18 years of age at the time of informed consent
✓. 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).
✓. Cohort B: Histologically or cytologically confirmed, locally advanced, unresectable or metastatic pancreatic ductal adenocarcinoma.
✓. No prior systemic treatment for locally advanced, unresectable or metastatic disease
✓. Measurable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST) guidelines.
✓. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
✓. Adequate organ function
✓. Able to take medications orally
Exclusion criteria
✕. Has locally advanced disease that is resectable or potentially curable with radiation therapy (as determined by local investigator).
✕. Has an adenocarcinoma histology and is eligible to receive approved targeted therapy (eg, HER-2 positive patients).
✕. 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.