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

Primary Purpose

Locally Advanced Unresectable or Metastatic Esophageal Cancer

Status
Recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Futibatinib
Pembrolizumab
Cisplatin
5-FU
Oxaliplatin
Leucovorin
Levoleucovorin
Sponsored by
Taiho Oncology, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Locally Advanced Unresectable or Metastatic Esophageal Cancer focused on measuring Futibatinib, Advanced esophageal cancer, Esophageal cancer, TAS-120, Immunotherapy, Esophageal squamous cell cancer (ESCC), GEJ cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Is ≥18 years of age at the time of informed consent 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). No prior systemic treatment for locally advanced, unresectable or metastatic esophageal carcinoma. Measurable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST) guidelines. Have documentation of PD-L1 CPS score. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 Adequate organ function Able to take medications orally Exclusion Criteria: Has locally advanced esophageal carcinoma 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. Has known additional malignancy that is progressing or requires active treatment . History or current evidence of calcium and phosphate homeostasis disorder Current evidence of clinically significant retinal disorder Pregnant or lactating female. Has known hypersensitivity or severe reaction to any of the study drugs or their excipients. Has a diagnosis of immunodeficiency. 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. Has an active autoimmune disease that has required systemic treatment in the past 2 years Has a history of (noninfectious) pneumonitis that required steroids or has current pneumonitis. Has had an allogenic tissue/organ transplant.

Sites / Locations

  • Gabrail Cancer Center Research LLCRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

futibatinib + pembrolizumab + chemotherapy

Arm Description

Futibatinib will be administered once daily on a continuous dosing regimen in combination with pembrolizumab plus investigator choice of SoC chemotherapy of FP or mFOLFOX6 induction phase followed by a Futibatinib Plus Pembrolizumab consolidation phase.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.
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
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
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
6-month PFS rate
defined as percentage of patients without disease progression within 6 months of enrollment

Full Information

First Posted
July 6, 2023
Last Updated
August 4, 2023
Sponsor
Taiho Oncology, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT05945823
Brief Title
Phase 2 Futibatinib in Combination With PD-1 Antibody Based Standard of Care in 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.
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 13, 2023 (Actual)
Primary Completion Date
January 2025 (Anticipated)
Study Completion Date
May 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Taiho Oncology, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.
Detailed Description
Patients with locally advanced, unresectable or metastatic esophageal cancer (EC) will receive futibatinib in combination with pembrolizumab plus Investigator choice of chemotherapy (FP or mFOLFOX6). The study will begin with a safety lead-in period (Part 1), in which approximately 12 patients with advanced or metastatic esophageal cancer will be enrolled. In Part 2, approximately 14 EC patients will be enrolled and treated with the same treatment regimen.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Locally Advanced Unresectable or Metastatic Esophageal Cancer
Keywords
Futibatinib, Advanced esophageal cancer, Esophageal cancer, TAS-120, Immunotherapy, Esophageal squamous cell cancer (ESCC), GEJ cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
26 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
futibatinib + pembrolizumab + chemotherapy
Arm Type
Experimental
Arm Description
Futibatinib will be administered once daily on a continuous dosing regimen in combination with pembrolizumab plus investigator choice of SoC chemotherapy of FP or mFOLFOX6 induction phase followed by a Futibatinib Plus Pembrolizumab consolidation phase.
Intervention Type
Drug
Intervention Name(s)
Futibatinib
Other Intervention Name(s)
TAS-120
Intervention Description
TAS-120 20 mg tablets, oral; once daily
Intervention Type
Drug
Intervention Name(s)
Pembrolizumab
Other Intervention Name(s)
MK-3475, KEYTRUDA®
Intervention Description
400 mg once every 6-week-cycle, via IV infusion.
Intervention Type
Drug
Intervention Name(s)
Cisplatin
Other Intervention Name(s)
PLATINOL®
Intervention Description
80 mg/m^2 Q3W via IV infusion, as part of investigator's choice FP chemotherapy
Intervention Type
Drug
Intervention Name(s)
5-FU
Other Intervention Name(s)
ADRUCIL®
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Oxaliplatin
Other Intervention Name(s)
ELOXATIN®
Intervention Description
85 mg/m^2 Q2W via IV infusion, as part of investigator's choice mFOLFOX6 chemotherapy.
Intervention Type
Drug
Intervention Name(s)
Leucovorin
Other Intervention Name(s)
Calcium folinate, Folinic acid, WELLCOVORIN®
Intervention Description
400 mg/m^2 Q2W as part of investigator's choice mFOLFOX6 chemotherapy
Intervention Type
Drug
Intervention Name(s)
Levoleucovorin
Other Intervention Name(s)
calcium levofolinate, levofolinic acid, FUSILEV®
Intervention Description
200 mg/m^2 Q2W as part of investigator's choice mFOLFOX6 chemotherapy.
Primary Outcome Measure Information:
Title
ORR by investigator assessment
Description
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
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Treatment-emergent adverse events (TEAEs) as assessed by CTCAE v5.0
Description
Safety will be assessed based on reported AEs (including SAEs), graded by CTCAE V5.0., and dose modifications.
Time Frame
12 months
Title
DoR per investigator assessment
Description
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
Time Frame
12 months
Title
DCR per investigator assessment
Description
defined as percentage of patients who achieve complete response, partial response or stable disease per RECIST 1.1 by investigator assessment
Time Frame
12 months
Title
PFS per investigator assessment
Description
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
Time Frame
12 months
Title
6-month PFS rate
Description
defined as percentage of patients without disease progression within 6 months of enrollment
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Is ≥18 years of age at the time of informed consent 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). No prior systemic treatment for locally advanced, unresectable or metastatic esophageal carcinoma. Measurable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST) guidelines. Have documentation of PD-L1 CPS score. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 Adequate organ function Able to take medications orally Exclusion Criteria: Has locally advanced esophageal carcinoma 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. Has known additional malignancy that is progressing or requires active treatment . History or current evidence of calcium and phosphate homeostasis disorder Current evidence of clinically significant retinal disorder Pregnant or lactating female. Has known hypersensitivity or severe reaction to any of the study drugs or their excipients. Has a diagnosis of immunodeficiency. 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. Has an active autoimmune disease that has required systemic treatment in the past 2 years Has a history of (noninfectious) pneumonitis that required steroids or has current pneumonitis. Has had an allogenic tissue/organ transplant.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Taiho Oncology, Inc
Phone
609-250-7336
Email
clinicaltrialinfo@taihooncology.com
Facility Information:
Facility Name
Gabrail Cancer Center Research LLC
City
Canton
State/Province
Ohio
ZIP/Postal Code
44718
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
330-492-3345
Email
csmith@gabrailcancercenter.com

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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