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Chemotherapy

Zolbetuximab + Chemotherapy for Pancreatic Cancer

Phase 1
Recruiting
Research Sponsored by Astellas Pharma Global Development, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Participant has histologically or cytologically confirmed adenocarcinoma of pancreas
Participant's tumor is CLDN18.2 positive
Must not have
Participant has pleural effusion or ascites ≥ Grade 3 per CTCAE v5.0
Participant has active autoimmune disease, infection, or significant cardiovascular disease
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 16 months
Awards & highlights

Summary

"This trial aims to test the effectiveness and safety of a new drug called zolbetuximab, given alongside chemotherapy, for people with advanced pancreatic cancer. Zolbetuximab targets a

Who is the study for?
Adults over 18 with metastatic pancreatic cancer who haven't had chemotherapy can join this study. They must have a specific protein on their tumor cells and not be pregnant or breastfeeding. Participants need measurable cancer lesions, cannot have progressed after certain chemotherapies, and women must agree to contraception for six months post-treatment.
What is being tested?
The trial is testing zolbetuximab combined with mFOLFIRINOX chemotherapy in patients with pancreatic cancer. Zolbetuximab targets a protein on the tumor to activate the immune system against it. The treatment is given through an infusion every two weeks in a cycle of 28 days.
What are the potential side effects?
Potential side effects may include reactions at the infusion site, immune-related responses due to activation by zolbetuximab, typical chemotherapy side effects like nausea, fatigue, blood cell count changes, and increased risk of infections.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My cancer is a type of pancreatic cancer confirmed by lab tests.
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My tumor is CLDN18.2 positive.
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I am not pregnant and follow the required birth control measures.
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My pancreatic cancer has spread and I haven't had chemotherapy.
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I am fully active or can carry out light work.
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I am following the required birth control measures.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have severe fluid buildup in my chest or abdomen.
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I have an active autoimmune disease, infection, or serious heart condition.
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I have a known DPD deficiency.
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I have had interstitial pneumonia or pulmonary fibrosis.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 16 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 16 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Incidence of Dose Limiting Toxicities (DLT)
Number of participants at each grade of Eastern Cooperative Oncology Group (ECOG) performance status scores
Number of participants with electrocardiograms (ECG) abnormalities and or adverse events
+3 more
Secondary study objectives
Best Overall Response (BOR) Rate
Change from baseline in Cancer Antigen 19-9 (CA 19-9)
Disease Control Rate (DCR)
+3 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: zolbetuximab and mFOLFIRINOXExperimental Treatment2 Interventions
Participants will receive 1 of 2 dose levels of zolbetuximab in combination with mFOLFIRINOX.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
zolbetuximab
2019
Completed Phase 2
~270
mFOLFIRINOX
2013
Completed Phase 2
~80

Find a Location

Who is running the clinical trial?

Astellas Pharma Global Development, Inc.Lead Sponsor
199 Previous Clinical Trials
122,665 Total Patients Enrolled
Medical DirectorStudy DirectorAstellas Pharma Global Development, Inc.
2,834 Previous Clinical Trials
8,079,768 Total Patients Enrolled
~8 spots leftby Jul 2026
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