Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at UCLA
Dates
study started
completion around
Principal Investigator
by Rosen Lee (ucla)

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. The study will begin with a safety lead-in period (Part 1), in which up to 18 patients (Cohort A = up to12, Cohort B = 6 ) will be enrolled. In Part 2, up to 54 patients (Cohort A = up to 20, Cohort B = 34) will be enrolled and treated with the same treatment regimens.

Keywords

Locally Advanced, Unresectable, or Metastatic Solid Tumors, Including Esophageal and Pancreatic Cancer, Futibatinib, Advanced esophageal cancer, Esophageal cancer, TAS-120, Immunotherapy, Esophageal squamous cell cancer (ESCC), GEJ cancer, pancreatic ductal adenocarcinoma, pancreatic cancer, Pancreatic Neoplasms, Dietary Calcium, Leucovorin, Pembrolizumab, Oxaliplatin, Irinotecan, Calcium, Levoleucovorin, Cisplatin, futibatinib + pembrolizumab + chemotherapy

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 not yet accepting patients
    Santa Monica California 90404 United States
  • Virginia Mason Medical Center not yet accepting patients
    Seattle Washington 98101 United States
  • Gundersen Lutheran Health System accepting new patients
    La Crosse Wisconsin 54601 United States
  • Gabrail Cancer Center Research LLC accepting new patients
    Canton Ohio 44718 United States

Lead Scientist at University of California Health

Details

Status
accepting new patients at some sites,
but this study is not currently recruiting here
Start Date
Completion Date
(estimated)
Sponsor
Taiho Oncology, Inc.
ID
NCT05945823
Phase
Phase 2 research study
Study Type
Interventional
Participants
Expecting 26 study participants
Last Updated