A Study of Zolbetuximab With Chemotherapy in Adults With Pancreatic Cancer

StatusActive, Not Recruiting
PhasePhase 1
Started

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Trial flagged as At Risk
Primary completion moved at least 5 months later Jul 31, 2026 → Dec 31, 2026
See other at-risk trials from Astellas Pharma Global Development, Inc.

Record History

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  1. Notable Primary endpoints: details revised at 2 of 6 entries
    • Primary and study completion pushed from Jul 31, 2026 to Dec 31, 2026
    • Eligibility criteria expanded, about 52 words
    • Secondary endpoints: details revised at 1 of 7 entries
  2. Minor Trial status: Recruiting to Active, Not Recruiting
    • Study sites: 7 to 1
    v9
  3. Notable Start date: Jul 22, 2024 to Sep 24, 2025
    • Primary and study completion dates: Jul 3, 2026 to Jul 31, 2026
    • Site details revised at 1 of 7 sites
    v8
  4. Minor Study sites: 5 to 7v7
  5. Minor Re-verified, no change to tracked fieldsv6
Show 4 earlier versionsHide 4 earlier versions
  1. Minor Study sites: 2 to 5v5
  2. Notable Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 2
    • Start date changed from estimate of Jul 31, 2024 to Jul 22, 2024
    v4
  3. Notable Start date: Jun 30, 2024 to Jul 31, 2024
    • Eligibility criteria expanded, about 13 words
    v3
  4. Notable Start date: May 31, 2024 to Jun 30, 2024v2
  1. Minor Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06396091
Lead Sponsor Astellas Pharma Global Development, Inc.
Conditions
(from sponsor)
Metastatic Pancreatic Adenocarcinoma
Enrollment 12 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov