Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at Santa Monica, California and other locations
Dates
study started
completion around
Principal Investigator
by Rosen Lee

Description

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.

Official Title

A Phase 2 Study of Futibatinib in Combination With PD-1 Antibody-based Standard of Care Therapy in Patients With Solid Tumors.

Details

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. Subjects will receive futibatinib in combination with pembrolizumab plus standard of care (SOC) chemotherapy during induction phase of the study and will continue on futibatinib in combination with pembrolizumab in consolidation phase.

Keywords

Locally Advanced Unresectable or Metastatic Solid Tumors Including Esophageal Cancer, Esophageal Adenocarcinoma, Esophageal Squamous Cell Cancer, Siewert Type 1 GEJ Cancer, Pancreatic Cancer, Futibatinib, Advanced esophageal cancer, Esophageal cancer, TAS-120, Immunotherapy, Esophageal squamous cell cancer (ESCC), GEJ cancer, pancreatic ductal adenocarcinoma, Adenocarcinoma, Pancreatic Neoplasms, Esophageal Neoplasms, Squamous Cell Neoplasms, Squamous Cell Carcinoma, Esophageal Squamous Cell Carcinoma, Dietary Calcium, Leucovorin, Pembrolizumab, Oxaliplatin, Irinotecan, Calcium, Levoleucovorin, Cisplatin

Eligibility

You can join if…

Open to people ages 18 years and up

  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

You CAN'T join if...

  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.

Locations

  • University of California Los Angeles UCLA - Cancer Care - Santa Monica accepting new patients
    Santa Monica California 90404 United States
  • Rocky Mountain Cancer Centers Midtown accepting new patients
    Denver Colorado 80218 United States

Lead Scientist at UCLA

  • Rosen Lee
    HS Clinical Professor, Medicine. Authored (or co-authored) 115 research publications

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Taiho Oncology, Inc.
Links
Sign up for this study
ID
NCT05945823
Phase
Phase 2 research study
Study Type
Interventional
Participants
Expecting 66 study participants
Last Updated