Futibatinib With Paclitaxel and Ramucirumab for the Treatment of Locally Advanced or Unresectable Gastric, Gastroesophageal Junction, or Esophageal Adenocarcinoma

Part of paid clinical trials in Chicago, Illinois.

Sponsor
Northwestern University
Study ID
NCT07594548
Phase
PHASE1
Status
Not Yet Recruiting

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Conditions

  • Clinical Stage II Esophageal Adenocarcinoma AJCC v8
  • Clinical Stage III Esophageal Adenocarcinoma AJCC v8
  • Clinical Stage III Gastric Cancer AJCC v8
  • Clinical Stage III Gastroesophageal Junction Adenocarcinoma AJCC v8
  • Clinical Stage IV Esophageal Adenocarcinoma AJCC v8
  • Clinical Stage IV Gastric Cancer AJCC v8
  • Clinical Stage IV Gastroesophageal Junction Adenocarcinoma AJCC v8
  • Locally Advanced Esophageal Adenocarcinoma
  • Locally Advanced Gastric Adenocarcinoma
  • Locally Advanced Gastroesophageal Junction Adenocarcinoma
  • Metastatic Esophageal Adenocarcinoma
  • Metastatic Gastric Adenocarcinoma
  • Metastatic Gastroesophageal Junction Adenocarcinoma
  • Unresectable Esophageal Adenocarcinoma
  • Unresectable Gastric Adenocarcinoma
  • Unresectable Gastroesophageal Junction Carcinoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Biospecimen Collection — PROCEDURE
    Undergo blood and urine sample collection
  • Computed Tomography — PROCEDURE
    Undergo CT scan
  • Futibatinib — DRUG
    Given PO
  • Magnetic Resonance Imaging — PROCEDURE
    Undergo MRI
  • Paclitaxel — DRUG
    Given IV
  • Ramucirumab — BIOLOGICAL
    Given IV

Study Details

This phase I trial tests the safety, side effects and best dose of futibatinib with paclitaxel and ramucirumab for the treatment of patients with gastric, gastroesophageal junction or esophageal adenocarcinoma that has spread to nearby tissue or lymph nodes (locally advanced) or that cannot be removed by surgery (unresectable). Futibatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Paclitaxel is in a class of medications called antimicrotubule agents. It stops cancer cells from growing and dividing and may kill them. Ramucirumab is a monoclonal antibody that may prevent the growth of new blood vessels that tumors need to grow. Giving futibatinib with paclitaxel and ramucirumab may be safe and tolerable in treating patients with locally advanced or unresectable gastric, gastroesophageal junction or esophageal adenocarcinoma.

Key Dates

Start date
Sep 9, 2027
Status verified
May 2026
Primary completion
Sep 9, 2030
Completion
Sep 9, 2031

Study Design

Enrollment
18 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment (futibatinib, paclitaxel, ramucirumab)
    Patients receive ramucirumab IV over 30-60 minutes on days 1 and 15 of each cycle, paclitaxel IV over 60 minutes on days 1, 8 and 15 of each cycle, and futibatinib PO QD on days 8-28 of cycle 1 and days 1-28 of subsequent cycles. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients undergo CT or MRI, and optional blood and urine sample collection throughout the study.

Primary Outcome Measure

Maximum tolerated dose [ Time Frame: From cycles 1 day 8 (start of Futibatinib) to cycle 2 day 8 (cycle length = 28 days) ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Northwestern UniversityChicagoIllinois60611
Chengwei Peng, MD
[email protected]
312-926-6180
Chengwei Peng, MD (PRINCIPAL_INVESTIGATOR)
Ohio State UniversityColumbusOhio43210
Shafia Raham, MD
[email protected]
614-293-6529

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