Neoplasms

All Conditions

Digestive System Diseases

Gland and Hormone Related Diseases

Rare Diseases

Carcinoma, Squamous Cell

Esophageal Neoplasms

Pancreatic Neoplasms

Adenocarcinoma

Esophageal Squamous Cell Carcinoma

Neoplasms, Squamous Cell

Carcinoma

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Gastrointestinal Neoplasms

Digestive System Neoplasms

Endocrine Gland Neoplasms

Gastrointestinal Diseases

Pancreatic Diseases

Endocrine System Diseases

Head and Neck Neoplasms

Esophageal Diseases

Esophageal Cancer

Pancreatic Cancer

Antineoplastic Agents

All Drugs and Chemicals

Micronutrients

Hematinics

Bone Density Conservation Agents

Vitamins

Irinotecan

Antibodies

Pembrolizumab

Leucovorin

Fluorouracil

Levoleucovorin

Cisplatin

Immunomodulating Agents

Oxaliplatin

Calcium

Folic Acid

Immunoglobulins

Calcium, Dietary

Futibatinib

Antineoplastic Agents, Immunological

Immune Checkpoint Inhibitors

Hormones

Topoisomerase I Inhibitors

Enzyme Inhibitors

Antidotes

Protective Agents

Vitamin B Complex

Trace Elements

Folinic Acid

Folate

Vitamin B9

Patients with Esophageal cancer (Adenocarcinoma or Squamous cell cancer) will receive Futibatinib administered once daily on a continuous dosing regimen in combination with pembrolizumab plus investigator choice of SoC chemotherapy (FP or mFOLFOX6) for 6 cycles (induction phase) following by Futibatinib combination with pembrolizumab (consolidation phase).

Patients with PDAC will receive Futibatinib administered once daily on a continuous dosing regimen in combination with pembrolizumab plus mFOLFIRINOX for 6 cycles (induction phase) following by Futibatinib combination with pembrolizumab (consolidation phase) .

400 mg once every 6-week-cycle, via IV infusion.

80 mg/m\^2 Q3W via IV infusion, as part of investigator's choice FP chemotherapy

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.

5-FU

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.

400 mg/m\^2 Q2W as part of mFOLFIRINOX or mFOLFOX6 chemotherapy.

200 mg/m\^2 Q2W as part of investigator's choice mFOLFOX6 chemotherapy.

150 mg/m\^2 Q2W as part of mFOLFIRINOX chemotherapy.

Taiho Oncology, Inc

Rosen Lee

Allen Cohn

Mike Cusnir

Rutika Mehta

Gazala Khan

Carl Minniti

Sarbajit Mukherjee

Jennifer Chuy

Nashat Gabrail

Joseph Potz

Michael Gibson

David Wang

Jasmine Huynh

Mark Kochenderfer

Bruce Lin

Kurt Oettel

Anne Plaquinn

David Tougeron

Thorsten Goetze

Markus Moehler

Marc Diez Garcia

Carlos Jesus Gomez Martin

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.

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.

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

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

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

Safety will be assessed based on reported AEs (including SAEs), graded by CTCAE V5.0., and dose modifications.

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

defined as percentage of patients who achieve complete response, partial response or stable disease per RECIST 1.1 by 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

defined as percentage of patients without disease progression within 6 months of enrollment

Taiho Oncology, Inc.

Spots Global Cancer Trial Database for esophageal squamous cell cancer (escc)