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

Pancreatic Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05945823
• Other study ID #: TAS-120-206
• Status: Recruiting
• Phase: Phase 2
• Start date: July 13, 2023
• Est. completion date: May 2025

Study information

• Verified date: February 2024
• Source: Taiho Oncology, Inc.
• Contact: Taiho Oncology, Inc
• Phone: 609-250-7336
• Email: clinicaltrialinfo[@]taihooncology.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 66
• Est. completion date: May 2025
• Est. primary completion date: January 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Adenocarcinoma
• Carcinoma, Squamous Cell
• Esophageal Adenocarcinoma
• Esophageal Neoplasms
• Esophageal Squamous Cell Cancer
• Esophageal Squamous Cell Carcinoma
• Neoplasms, Squamous Cell
• Pancreatic Cancer
• Pancreatic Neoplasms

Intervention

Drug:
• 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.

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Taiho Oncology, Inc.

Countries where clinical trial is conducted

United States,  France,  Germany,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	ORR by investigator assessment	Defined as the proportion of patients experiencing a best overall response of partial response (PR) or complete response (CR) (per RECIST 1.1), based on investigator assessment	12 months
Secondary	Treatment-emergent adverse events (TEAEs) as assessed by CTCAE v5.0	Safety will be assessed based on reported AEs (including SAEs), graded by CTCAE V5.0., and dose modifications.	12 months
Secondary	DoR per investigator assessment	defined as time from the first documentation of response to the first documentation of objective tumor progression or death due to any cause, whichever occurs first	12 months
Secondary	DCR per investigator assessment	defined as percentage of patients who achieve complete response, partial response or stable disease per RECIST 1.1 by investigator assessment	12 months
Secondary	PFS per investigator assessment	defined as the time from date of enrollment to the date of disease progression based on Investigator assessment of radiographic images or death, whichever occurs first	12 months
Secondary	6-month PFS rate	defined as percentage of patients without disease progression within 6 months of enrollment	12 months