Trial Title:
Phase 2 Futibatinib in Combination With PD-1 Antibody Based Standard of Care in Solid Tumors
NCT ID:
NCT05945823
Condition:
Locally Advanced Unresectable or Metastatic Solid Tumors Including Esophageal Cancer
Esophageal Adenocarcinoma
Esophageal Squamous Cell Cancer
Siewert Type 1 GEJ Cancer
Pancreatic Cancer
Conditions: Official terms:
Adenocarcinoma
Pancreatic Neoplasms
Esophageal Neoplasms
Neoplasms, Squamous Cell
Carcinoma, Squamous Cell
Esophageal Squamous Cell Carcinoma
Calcium, Dietary
Leucovorin
Pembrolizumab
Oxaliplatin
Irinotecan
Futibatinib
Calcium
Levoleucovorin
Conditions: Keywords:
Futibatinib
Advanced esophageal cancer
Esophageal cancer
TAS-120
Immunotherapy
Esophageal squamous cell cancer (ESCC)
GEJ cancer
pancreatic ductal adenocarcinoma
pancreatic cancer
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Futibatinib
Description:
TAS-120 20 mg tablets, oral; once daily
Arm group label:
Cohort A
Arm group label:
Cohort B
Other name:
TAS-120
Intervention type:
Drug
Intervention name:
Pembrolizumab
Description:
400 mg once every 6-week-cycle, via IV infusion.
Arm group label:
Cohort A
Arm group label:
Cohort B
Other name:
MK-3475
Other name:
KEYTRUDA®
Intervention type:
Drug
Intervention name:
Cisplatin
Description:
80 mg/m^2 Q3W via IV infusion, as part of investigator's choice FP chemotherapy
Arm group label:
Cohort A
Other name:
PLATINOL®
Intervention type:
Drug
Intervention name:
5-FU
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.
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.
Arm group label:
Cohort A
Arm group label:
Cohort B
Other name:
ADRUCIL®
Intervention type:
Drug
Intervention name:
Oxaliplatin
Description:
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.
Arm group label:
Cohort A
Arm group label:
Cohort B
Other name:
ELOXATIN®
Intervention type:
Drug
Intervention name:
Leucovorin
Description:
400 mg/m^2 Q2W as part of mFOLFIRINOX or mFOLFOX6 chemotherapy.
Arm group label:
Cohort A
Arm group label:
Cohort B
Other name:
calcium folinate
Other name:
folinic acid
Other name:
WELLCOVORIN®
Intervention type:
Drug
Intervention name:
Levoleucovorin
Description:
200 mg/m^2 Q2W as part of investigator's choice mFOLFOX6 chemotherapy.
Arm group label:
Cohort A
Arm group label:
Cohort B
Other name:
calcium levofolinate
Other name:
levofolinic acid
Other name:
FUSILEV®
Intervention type:
Drug
Intervention name:
Irinotecan
Description:
150 mg/m^2 Q2W as part of mFOLFIRINOX chemotherapy.
Arm group label:
Cohort B
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) 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.
Criteria for 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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
University of California Los Angeles UCLA - Cancer Care - Santa Monica
Address:
City:
Santa Monica
Zip:
90404
Country:
United States
Status:
Recruiting
Contact:
Phone:
310-633-8400
Email:
lrosen@mednet.ucla.edu
Investigator:
Last name:
Rosen Lee
Email:
Principal Investigator
Facility:
Name:
Rocky Mountain Cancer Centers Midtown
Address:
City:
Denver
Zip:
80218
Country:
United States
Status:
Recruiting
Contact:
Phone:
303-388-4876
Email:
allen.cohn@usoncology.com
Investigator:
Last name:
Allen Cohn
Email:
Principal Investigator
Facility:
Name:
Mount Sinai Comprehensive Cancer Center
Address:
City:
Miami Beach
Zip:
33140
Country:
United States
Status:
Recruiting
Contact:
Phone:
305-535-3300
Email:
mike.cusnir@msmc.com
Investigator:
Last name:
Mike Cusnir
Email:
Principal Investigator
Facility:
Name:
Moffitt Cancer Center and Research Institute
Address:
City:
Tampa
Zip:
33612
Country:
United States
Status:
Not yet recruiting
Contact:
Phone:
813-745-4673
Email:
rutika.mehta@moffitt.org
Investigator:
Last name:
Rutika Mehta
Email:
Principal Investigator
Facility:
Name:
Henry Ford Health System
Address:
City:
Detroit
Zip:
48202
Country:
United States
Status:
Recruiting
Contact:
Phone:
888-734-5322
Email:
GKHAN1@hfhs.org
Investigator:
Last name:
Gazala Khan
Email:
Principal Investigator
Facility:
Name:
The Minniti Center - Medical Oncology and Hematology
Address:
City:
Mickleton
Zip:
08056
Country:
United States
Status:
Recruiting
Contact:
Phone:
856-423-0754
Email:
CJMinniti@gmail.com
Investigator:
Last name:
Carl Minniti
Email:
Principal Investigator
Facility:
Name:
Roswell Park Comprehensive Cancer Center (RPCCC) (Roswell Park Cancer Institute (RPCI))
Address:
City:
Buffalo
Zip:
14203
Country:
United States
Status:
Recruiting
Contact:
Phone:
716-845-2300
Email:
sarbajit.mukherjee@roswellpark.org
Investigator:
Last name:
Sarbajit Mukherjee
Email:
Principal Investigator
Facility:
Name:
NYU Langone
Address:
City:
New York
Zip:
10016
Country:
United States
Status:
Recruiting
Contact:
Phone:
718-405-8535
Email:
Jennifer.Chuy@nyulangone.org
Investigator:
Last name:
Jennifer Chuy
Email:
Principal Investigator
Facility:
Name:
Gabrail Cancer Center Research LLC
Address:
City:
Canton
Zip:
44718
Country:
United States
Status:
Recruiting
Contact:
Phone:
330-492-3345
Email:
csmith@gabrailcancercenter.com
Investigator:
Last name:
Nashat Gabrail
Email:
Principal Investigator
Facility:
Name:
Alliance Cancer Specialists
Address:
City:
Horsham
Zip:
19044
Country:
United States
Status:
Recruiting
Contact:
Phone:
215-706-2034
Email:
jpotz@abingtonhemeonc.com
Investigator:
Last name:
Joseph Potz
Email:
Principal Investigator
Facility:
Name:
Vanderbilt University Medical Center
Address:
City:
Nashville
Zip:
37232
Country:
United States
Status:
Recruiting
Contact:
Phone:
615-875-3417
Email:
mike.gibson.1@vumc.org
Investigator:
Last name:
Michael Gibson
Email:
Principal Investigator
Facility:
Name:
Dallas VA Medical Center
Address:
City:
Dallas
Zip:
75216
Country:
United States
Status:
Recruiting
Contact:
Phone:
214-857-0737
Email:
david1.wang@utsouthwestern.edu
Investigator:
Last name:
David Wang
Email:
Principal Investigator
Facility:
Name:
Inova Schar Cancer Institute
Address:
City:
Fairfax
Zip:
22031
Country:
United States
Status:
Recruiting
Contact:
Phone:
571-472-4724
Email:
Jasmine.Huynh@inova.org
Investigator:
Last name:
Jasmine Huynh
Email:
Principal Investigator
Facility:
Name:
Blue Ridge Cancer Care
Address:
City:
Roanoke
Zip:
24014
Country:
United States
Status:
Recruiting
Contact:
Phone:
504-808-1704
Email:
mark.kochenderfer@usoncology.com
Investigator:
Last name:
Mark Kochenderfer
Email:
Principal Investigator
Facility:
Name:
Virginia Mason Medical Center
Address:
City:
Seattle
Zip:
98101
Country:
United States
Status:
Recruiting
Contact:
Phone:
206-223-2319
Email:
Bruce.Lin@vmmc.org
Investigator:
Last name:
Bruce Lin
Email:
Principal Investigator
Facility:
Name:
Gundersen Lutheran Health System
Address:
City:
La Crosse
Zip:
54601
Country:
United States
Status:
Recruiting
Contact:
Phone:
608-775-2837
Email:
kroettel@gundersenhealth.org
Investigator:
Last name:
Kurt Oettel
Email:
Principal Investigator
Facility:
Name:
Centre Hospitalier Regional Universitaire de Lille
Address:
City:
Lille Cedex
Zip:
59037
Country:
France
Status:
Recruiting
Contact:
Phone:
3 20 44 54 61
Email:
anne.thevenin@chu-lille.fr
Investigator:
Last name:
Anne Plaquinn
Email:
Principal Investigator
Facility:
Name:
Centre Hospitalier Regional Universitaire Poitiers
Address:
City:
Poitiers
Zip:
86000
Country:
France
Status:
Recruiting
Contact:
Phone:
33 05 49 44 48 86
Email:
David.TOUGERON@chu-poitiers.fr
Investigator:
Last name:
David Tougeron
Email:
Principal Investigator
Facility:
Name:
Krankenhaus Nordwest gGmbH
Address:
City:
Frankfurt
Zip:
60488
Country:
Germany
Status:
Recruiting
Contact:
Phone:
6976 014187
Email:
Goetze.Thorsten@khnw.de
Investigator:
Last name:
Thorsten Goetze
Email:
Principal Investigator
Facility:
Name:
Universitaetsmedizin Mainz
Address:
City:
Mainz
Zip:
55131
Country:
Germany
Status:
Recruiting
Contact:
Phone:
49-6131-175712
Email:
markus.moehler@unimedizin-mainz.de
Investigator:
Last name:
Markus Moehler
Email:
Principal Investigator
Facility:
Name:
Hospital Universitari Vall d'Hebron
Address:
City:
Barcelona
Zip:
08035
Country:
Spain
Status:
Recruiting
Contact:
Phone:
34-932 54 34 50
Email:
mdiez@vhio.net
Investigator:
Last name:
Marc Diez Garcia
Email:
Principal Investigator
Facility:
Name:
Hospital Universitario 12 de Octubre
Address:
City:
Madrid
Zip:
28041
Country:
Spain
Status:
Recruiting
Contact:
Phone:
34-913 90 80 00
Email:
cgomezm@seom.org
Investigator:
Last name:
Carlos Jesus Gomez Martin
Email:
Principal Investigator
Start date:
July 13, 2023
Completion date:
May 2025
Lead sponsor:
Agency:
Taiho Oncology, Inc.
Agency class:
Industry
Source:
Taiho Oncology, Inc.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05945823
