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Cancer cocktail shows promise in early trial

NCT ID NCT05945823

Disease control Sponsor: Taiho Oncology, Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Sep 02, 2026 · Updated 4 times

Summary

This study tests a new drug called futibatinib combined with standard immunotherapy and chemotherapy in people with advanced esophageal or pancreatic cancer. The goal is to see if the combination can shrink tumors and control the disease. About 53 adults who have not had prior treatment will take part.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Futibatinib (a targeted cancer drug) combined with pembrolizumab (an immunotherapy) and chemotherapy
What this could lead to
If successful, this combination could offer a new treatment option for people with advanced esophageal or pancreatic cancer, potentially shrinking tumors and delaying disease progression.
What could go wrong
This is an early Phase 2 study with only 53 participants and no comparison group. The combination may cause significant side effects, and results may not apply to all patients.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

53 people

The number who actually took part.

Started

Jul 2023

Expected to finish

Jan 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

Adenocarcinoma Of Esophagus esophageal adenocarcinoma esophageal cancer Esophageal Neoplasms esophageal squamous cell carcinoma gastroesophageal junction adenocarcinoma malignant pancreatic neoplasm pancreatic ductal adenocarcinoma pancreatic neoplasm

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Esophageal adenocarcinoma Esophageal squamous cell cancer Locally advanced unresectable or metastatic solid tumors including esophageal cancer Pancreatic cancer Siewert type 1 gej cancer

Contacts and locations

Locations

  • Alliance Cancer Specialists

    Horsham, Pennsylvania, 19044, United States

  • Blue Ridge Cancer Care

    Roanoke, Virginia, 24014, United States

  • Centre Hospitalier Regional Universitaire Poitiers

    Poitiers, 86000, France

  • Centre Hospitalier Regional Universitaire de Lille

    Lille, 59037, France

  • Dallas VA Medical Center

    Dallas, Texas, 75216, United States

  • Gabrail Cancer Center Research LLC

    Canton, Ohio, 44718, United States

  • Gundersen Lutheran Health System

    La Crosse, Wisconsin, 54601, United States

  • Henry Ford Health System

    Detroit, Michigan, 48202, United States

  • Hospital Universitari Vall d'Hebron

    Barcelona, 08035, Spain

  • Hospital Universitario 12 de Octubre

    Madrid, 28041, Spain

  • Inova Schar Cancer Institute

    Fairfax, Virginia, 22031, United States

  • Krankenhaus Nordwest gGmbH

    Frankfurt, 60488, Germany

  • Moffitt Cancer Center and Research Institute

    Tampa, Florida, 33612, United States

  • Mount Sinai Comprehensive Cancer Center

    Miami Beach, Florida, 33140, United States

  • NYU Langone

    New York, New York, 10016, United States

  • Rocky Mountain Cancer Centers Midtown

    Denver, Colorado, 80218, United States

  • Roswell Park Comprehensive Cancer Center (RPCCC) (Roswell Park Cancer Institute (RPCI))

    Buffalo, New York, 14203, United States

  • The Minniti Center - Medical Oncology and Hematology

    Mickleton, New Jersey, 08056, United States

  • Universitaetsmedizin Mainz

    Mainz, 55131, Germany

  • University of California Los Angeles UCLA - Cancer Care - Santa Monica

    Santa Monica, California, 90404, United States

  • Vanderbilt University Medical Center

    Nashville, Tennessee, 37232, United States

  • Virginia Mason Medical Center

    Seattle, Washington, 98101, United States

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