A Study of Zolbetuximab With Chemotherapy in Adults With Pancreatic Cancer

Part of paid clinical trials in Seattle, Washington.

Sponsor
Astellas Pharma Global Development, Inc.
Study ID
NCT06396091
Phase
PHASE1
Status
Active Not Recruiting

Conditions

  • Metastatic Pancreatic Adenocarcinoma

Eligibility Criteria

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

Interventions

  • zolbetuximab — DRUG
    Zolbetuximab will be administered intravenously on day 1 then every two weeks.
  • mFOLFIRINOX — DRUG
    Modified oxaliplatin, leucovorin, irinotecan and fluorouracil (mFOLFIRINOX) will be administered intravenously within 2 days after administration of zolbetuximab.

Study Details

Pancreatic cancer is difficult to diagnose early. By the time people have been diagnosed, the cancer has usually spread to other parts of the body (metastatic). The standard treatment is chemotherapy, but other treatments are needed to improve outcomes in people with pancreatic cancer. In this study, zolbetuximab will be given together with chemotherapy to people with pancreatic cancer. Zolbetuximab attaches to a protein called CLDN18.2 found at high levels on the surface of the cancer tumor. This switches on the immune system to attack the tumor. Adults 18 years or older with metastatic pancreatic cancer who have not previously had chemotherapy can take part in the study. There are 2 main aims of this study: * To check the safety of zolbetuximab, when given with chemotherapy in people with metastatic pancreatic cancer * To check if people could cope with (tolerate) any medical problems during the study This is an open-label study. This means people in the study and the study doctors will know that people will receive zolbetuximab with chemotherapy. Different small groups will receive lower to higher doses of zolbetuximab with chemotherapy. Zolbetuximab and chemotherapy will be given through a vein. This is called an infusion. People will receive zolbetuximab on the first day they receive chemotherapy. This will happen every 14 days in a 28-day cycle. People will receive zolbetuximab and chemotherapy in the study clinic and at home. Also, doctors will check for any medical problems. People will also have a health check including blood tests. On some visits they will also have scans to check for any changes in their cancer. People will visit the study clinic about 7 days after they stop treatment. They will be asked about any medical problems and will have a health check including blood tests. After this, people will have several more visits to the study clinic for health checks. The number of visits and checks done at each visit will depend on the health of each person and whether they complete their treatment or not.

Key Dates

Start date
Sep 24, 2025
Status verified
Nov 2025
Primary completion
Jul 31, 2026
Completion
Jul 31, 2026

Study Design

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

Arms

  • Experimental: zolbetuximab and mFOLFIRINOX
    Participants will receive 1 of 2 dose levels of zolbetuximab in combination with mFOLFIRINOX.

Primary Outcome Measure

Incidence of Dose Limiting Toxicities (DLT) [ Time Frame: Up to 28 days ]

Locations (1)

FacilityCityStateZIPSite coordinators
Virginia Mason Medical CenterSeattleWashington98101-

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By research site
Virginia Mason Medical Center· Seattle, WA

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