Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05945823
Other study ID # TAS-120-206
Secondary ID
Status Recruiting
Phase Phase 2
First received
Last updated
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
Health authority
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.

Study Design


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
See also
  Status Clinical Trial Phase
Completed NCT05305001 - Germline Mutations Associated With Hereditary Pancreatic Cancer in Unselected Patients With Pancreatic Cancer in Mexico
Completed NCT02526017 - Study of Cabiralizumab in Combination With Nivolumab in Patients With Selected Advanced Cancers Phase 1
Recruiting NCT05497531 - Pilot Comparing ctDNA IDV vs. SPV Sample in Pts Undergoing Biopsies for Hepatobiliary and Pancreatic Cancers N/A
Recruiting NCT04927780 - Perioperative or Adjuvant mFOLFIRINOX for Resectable Pancreatic Cancer Phase 3
Recruiting NCT06054984 - TCR-T Cells in the Treatment of Advanced Pancreatic Cancer Early Phase 1
Recruiting NCT05919537 - Study of an Anti-HER3 Antibody, HMBD-001, With or Without Chemotherapy in Patients With Solid Tumors Harboring an NRG1 Fusion or HER3 Mutation Phase 1
Terminated NCT03140670 - Maintenance Rucaparib in BRCA1, BRCA2 or PALB2 Mutated Pancreatic Cancer That Has Not Progressed on Platinum-based Therapy Phase 2
Terminated NCT00529113 - Study With Gemcitabine and RTA 402 for Patients With Unresectable Pancreatic Cancer Phase 1
Recruiting NCT05168527 - The First Line Treatment of Fruquintinib Combined With Albumin Paclitaxel and Gemcitabine in Pancreatic Cancer Patients Phase 2
Active, not recruiting NCT04383210 - Study of Seribantumab in Adult Patients With NRG1 Gene Fusion Positive Advanced Solid Tumors Phase 2
Recruiting NCT05391126 - GENOCARE: A Prospective, Randomized Clinical Trial of Genotype-Guided Dosing Versus Usual Care N/A
Terminated NCT03300921 - A Phase Ib Pharmacodynamic Study of Neoadjuvant Paricalcitol in Resectable Pancreatic Cancer A Phase Ib Pharmacodynamic Study of Neoadjuvant Paricalcitol in Resectable Pancreatic Cancer Phase 1
Completed NCT03153410 - Pilot Study With CY, Pembrolizumab, GVAX, and IMC-CS4 (LY3022855) in Patients With Borderline Resectable Adenocarcinoma of the Pancreas Early Phase 1
Recruiting NCT03175224 - APL-101 Study of Subjects With NSCLC With c-Met EXON 14 Skip Mutations and c-Met Dysregulation Advanced Solid Tumors Phase 2
Recruiting NCT05679583 - Preoperative Stereotactic Body Radiation Therapy in Patients With Resectable Pancreatic Cancer Phase 2
Recruiting NCT04183478 - The Efficacy and Safety of K-001 in the Treatment of Advanced Pancreatic Cancer Phase 2/Phase 3
Terminated NCT03600623 - Folfirinox or Gemcitabine-Nab Paclitaxel Followed by Stereotactic Body Radiotherapy for Locally Advanced Pancreatic Cancer Early Phase 1
Recruiting NCT04584008 - Targeted Agent Evaluation in Digestive Cancers in China Based on Molecular Characteristics N/A
Recruiting NCT05351983 - Patient-derived Organoids Drug Screen in Pancreatic Cancer N/A
Completed NCT04290364 - Early Palliative Care in Pancreatic Cancer - a Quasi-experimental Study