Phase 2 Study of Futibatinib with PD-1 Antibody Therapy for Solid Tumors

Sponsor: Taiho Oncology, Inc.

Sponsor score: 40
Inactive

ClinicalTrials ID:NCT05945823

Provider View

This clinical trial is testing the combination of futibatinib and a PD-1 antibody therapy with standard chemotherapy in adults with certain advanced solid tumors, such as esophageal cancer and pancreatic cancer, to evaluate its effectiveness and safety.

Patient Parameters

Program Overview

This study is exploring the use of futibatinib combined with a PD-1 antibody therapy and standard chemotherapy in adults with advanced solid tumors, specifically esophageal cancer and pancreatic cancer. The trial aims to assess how well this combination works and how safe it is for patients.

Description

In this study, patients with advanced esophageal cancer or pancreatic cancer that cannot be surgically removed or has spread to other parts of the body will receive a combination of treatments. For esophageal cancer, patients will receive futibatinib along with pembrolizumab and a choice of standard chemotherapy (either FP or mFOLFOX6). For pancreatic cancer, patients will receive futibatinib with pembrolizumab and mFOLFIRINOX chemotherapy. The treatment is divided into two phases: an induction phase where patients receive the full combination of drugs, and a consolidation phase where they continue with futibatinib and pembrolizumab. The study will monitor the effectiveness and safety of this treatment approach.

Eligibility Criteria

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.

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