A Study of Zolbetuximab With Chemotherapy in Adults With Pancreatic Cancer (NCT06396091) | Clinical Trial Compass
Active — Not RecruitingPhase 1
A Study of Zolbetuximab With Chemotherapy in Adults With Pancreatic Cancer
United States12 participantsStarted 2025-09-24
Plain-language summary
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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Participant has histologically or cytologically confirmed adenocarcinoma of pancreas.
* Participant must have metastatic pancreatic adenocarcinoma that has not been previously treated with chemotherapy:
* Prior treatment with 5-fluorouracil or gemcitabine administered as a radiation sensitizer during and up to 4 weeks after radiation therapy is allowed (if there is lingering toxicity, then the sponsor should be consulted).
* If a participant received neoadjuvant/adjuvant therapy, tumor recurrence or disease progression must have occurred at least 6 months after completing the last dose of the neoadjuvant/adjuvant therapy.
* Participant whose disease progressed on prior treatment with mFOLFIRINOX are not eligible.
* Participant has a measurable lesion(s) on at least 1 metastatic site based on RECIST v1.1 within 28 days prior to enrollment. For participants with only 1 measurable lesion and prior radiotherapy, the lesion must be outside the field of prior radiotherapy or must have documented progression following radiation therapy.
* Participant's tumor is CLDN18.2 positive, defined as ≥ 75% of tumor cells demonstrating moderate to strong membranous CLDN18 staining as determined by central immunohistochemistry testing.
* Female subject is not pregnant and at least 1 of the following conditions apply:
* Not a woman of childbearing potential (WOCBP)
* WOCBP who has a negative urine or serum pregnancy test at screening or within 48 hours prior to…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Since this is a Phase 1 trial focused on safety and finding the right dose of zolbetuximab combined with chemotherapy, what does that mean for what's actually known so far about whether this combination works against my pancreatic cancer?
2The trial is listed as 'active but no longer recruiting,' which I understand means they're not taking new patients — is there any chance I could still be considered, or are there similar trials studying zolbetuximab that I should look into instead?
3The study is tracking serious safety signals like dose-limiting toxicities, lab abnormalities, and heart rhythm changes — given my current health, how concerned should I be about those specific risks if I were to consider a trial like this?
4Zolbetuximab targets a protein called claudin 18.2 — would my tumor need to be tested for that marker first, and do you know whether my cancer has been tested for it already?
5Compared to starting standard first-line chemotherapy for metastatic pancreatic cancer right now, what would be the trade-offs of waiting or pursuing a Phase 1 trial like this one, given where I am in my diagnosis?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Incidence of Dose Limiting Toxicities (DLT)
Timeframe: Up to 28 days
2
Safety assessed by Adverse Events (AEs)
Timeframe: Up to 16 months
3
Number of participants with laboratory value abnormalities and/or adverse events (AEs)
Timeframe: Up to 16 months
4
Number of participants with vital sign abnormalities and/or adverse events (AEs)
Timeframe: Up to 16 months
5
Number of participants with electrocardiograms (ECG) abnormalities and or adverse events
Timeframe: Up to 16 months
6
Number of participants at each grade of Eastern Cooperative Oncology Group (ECOG) performance status scores