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NCT Number: NCT05945823

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

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Locally Advanced Unresectable or Metastatic Solid Tumors Including Esophageal Cancer Adenocarcinoma Of Esophagus Carcinoma Carcinoma, Squamous Cell Digestive System Diseases Digestive System Neoplasms Endocrine Gland Neoplasms Endocrine System Diseases Esophageal Adenocarcinoma Esophageal Diseases Esophageal Neoplasms Esophageal Squamous Cell Cancer Esophageal Squamous Cell Carcinoma Gastrointestinal Diseases Gastrointestinal Neoplasms Head and Neck Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Neoplasms, Squamous Cell Pancreatic Cancer Pancreatic Diseases Pancreatic Neoplasms Siewert Type 1 GEJ Cancer

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Centre Hospitalier Regional Universitaire de Lille, Lille, France

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Is ≥18 years of age at the time of informed consent
  • 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).
  • Cohort B: Histologically or cytologically confirmed, locally advanced, unresectable or metastatic pancreatic ductal adenocarcinoma.
  • No prior systemic treatment for locally advanced, unresectable or metastatic disease
  • Measurable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST) guidelines.
  • Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
  • Adequate organ function
  • Able to take medications orally

Exclusion criteria

  • Has locally advanced disease 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.

Treatment and study plan

Futibatinib

Drug

TAS-120 20 mg tablets, oral; once daily

Other names: TAS-120

Pembrolizumab

Drug

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

Other names: MK-3475, KEYTRUDA®

Cisplatin

Drug

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

Other names: PLATINOL®

5-FU

Drug

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.

Other names: ADRUCIL®

Oxaliplatin

Drug

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.

Other names: ELOXATIN®

Leucovorin

Drug

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

Other names: calcium folinate, folinic acid, WELLCOVORIN®

Levoleucovorin

Drug

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

Other names: calcium levofolinate, levofolinic acid, FUSILEV®

Irinotecan

Drug

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

Primary outcomes

  1. ORR by investigator assessment

    Time frame: 12 months

    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 outcomes

  1. Treatment-emergent adverse events (TEAEs) as assessed by CTCAE v5.0

    Time frame: 12 months

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

  2. DoR per investigator assessment

    Time frame: 12 months

    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

  3. DCR per investigator assessment

    Time frame: 12 months

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

  4. PFS per investigator assessment

    Time frame: 12 months

    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

  5. 6-month PFS rate

    Time frame: 12 months

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

Sponsors and collaborators

Lead sponsor

Taiho Oncology, Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2026
Study completion
2027
First posted
Jul 14, 2023
Registry last updated
Apr 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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