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Metastatic Pancreatic AdenocarcinomaPhase 1NCT06396091

A Study of Zolbetuximab With Chemotherapy in Adults With Pancreatic Cancer

A Phase 1 study testing zolbetuximab and mFOLFIRINOX in people with Metastatic Pancreatic Adenocarcinoma, run by Astellas Pharma Global Development, Inc. at 1 site in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Metastatic Pancreatic Adenocarcinoma
What is being tested?
zolbetuximab and mFOLFIRINOX
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
12 participants
Where
1 siteUnited States
Study dates
24 Sep 2025to 31 Dec 2026
Phase
Phase 1
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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 day 1; and agrees to follow the contraceptive guidance from the time of informed consent through through 9 months after the final administration of oxaliplatin and 6 months after the final administration of all other study interventional drugs.
  • Female participant must not be breastfeeding or lactating starting at screening and throughout the treatment period and for 6 months after the final study intervention administration.
  • Female participant must not donate ova starting at first administration of study intervention and throughout the treatment period and for 6 months after the final study intervention administration.
  • A male participant must agree to use contraception with female partner(s) of childbearing potential (including breastfeeding partner) throughout the treatment period and for 6 months after final study intervention administration.
  • A male participant must agree to remain abstinent or use a condom with pregnant partner(s) for the duration of the pregnancy throughout the treatment period and for 6 months after final study intervention administration.
  • A male participant must not donate sperm during the treatment period and for 6 months after final study intervention administration.
  • Participant agrees not to participate in another interventional study while receiving study intervention in the present study/participating in the present study.
  • Participant has ECOG performance status 0 or 1.
  • Participant has predicted life expectancy ≥ 12 weeks.
  • Participant must meet all of the following criteria based on the laboratory tests collected within 14 days prior to enrollment. In case of multiple laboratory data within this period, the most recent data should be used.
  • Participant must meet all of criteria based on laboratory tests during screening period.

Who cannot join

  • Participant has prior severe allergic reaction; suspected, known immediate or delayed hypersensitivity; or intolerance or contraindication to known ingredients of zolbetuximab or other monoclonal antibody, including humanized or chimeric antibodies.
  • Participant has prior severe allergic reaction; suspected, known immediate or delayed hypersensitivity; or intolerance or contraindication to any component of mFOLFIRINOX.
  • Participant has known dihydropyrimidine dehydrogenase (DPD) deficiency.
  • Participant has a known history of a positive test for human immunodeficiency virus infection or known active hepatitis B (positive HBs Ag) or hepatitis C infection.
  • For participants who are negative for hepatitis B surface antigen, but hepatitis B core antibody positive, a hepatitis B virus deoxyribonucleic acid test will be performed and if positive, the participant will be excluded.
  • Participants with positive hepatitis C serology but negative hepatitis C virus ribonucleic acid test results are eligible.
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  • Participants treated for hepatitis C with undetectable viral load results are eligible.
  • Participant has a history of interstitial pneumonia or pulmonary fibrosis.
  • Participant has pleural effusion or ascites ≥ Grade 3 per Common Terminology Criteria for Adverse Events (CTCAE) v5.0.
  • Participant has an active autoimmune disease that has required systemic treatment in the past 3 months prior to enrollment.
  • Participant has active infection requiring systemic therapy that has not completely resolved within 7 days prior to enrollment.
  • Participant has significant cardiovascular disease, including:
  • Congestive heart failure (defined as New York Heart Association Class III or IV), myocardial infarction, unstable angina, coronary angioplasty, coronary stenting,coronary artery bypass graft, cerebrovascular accident or hypertensive crisis within 6 months prior to enrollment;
  • History of clinically significant ventricular arrhythmias (i.e., sustained ventricular tachycardia, ventricular fibrillation or torsades de pointes);
  • QT interval corrected for heart rate (QTc) > 450 msec for male participants; QTc interval > 470 msec for female participants;
  • Cardiac arrhythmias requiring anti-arrhythmic medications (Participants with rate-controlled atrial fibrillation for > 1 month prior to enrollment are eligible).
  • Participant has a history of central nervous system metastases and/or carcinomatous meningitis from pancreatic adenocarcinoma.
  • Participant has known peripheral sensory neuropathy ≥ Grade 2 per CTCAE v5.0 unless the absence of deep tendon reflexes is the sole neurological abnormality.
  • Participant has had diarrhea within 24 hours prior to enrollment.
  • Participant has had a major surgical procedure ≤ 28 days prior to enrollment.
  • Participant without complete recovery from a major surgical procedure ≤ 14 days prior to enrollment.
  • Participant has a psychiatric illness or social situations that would preclude study compliance.
  • Participant has another malignancy for which treatment is required.
  • Participant has any concurrent disease, infection or co-morbid condition that interferes with the ability of the participant to participate in the study, which places the participant at undue risk or complicates the interpretation of data.
  • Participant has received radiotherapy for metastatic pancreatic adenocarcinoma unless the radiotherapy was completed > 14 days prior to enrollment and has recovered from any related toxicity.
  • Participant has received systemic immunosuppressive therapy, including systemic corticosteroids within 14 days prior to enrollment.
  • Participant using a physiologic replacement dose of hydrocortisone or its equivalent (defined as up to 30 mg per day of hydrocortisone or up to 10 mg per day of prednisone), receiving a single dose of systemic corticosteroids or receiving systemic corticosteroids as premedication for radiologic imaging contrast use is allowed.
  • Participant has a present or previous history of participation in a study of the study intervention.
  • Participant has a previous history of investigational study intervention administration.
  • Participant uses strong inhibitors or inducers of CYP3A or UGT1A1 when using irinotecan.
  • Participant has received any investigational therapy within 28 days prior to screening.
  • Participant has any condition which makes the participant unsuitable for study participation.

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Virginia Mason Medical Center

    Seattle, Washington, 98101

Other trials in United States

About this study

Official title: A Phase 1 Open-label Study to Assess the Safety and Tolerability of Zolbetuximab (IMAB362) in Combination With Chemotherapy (mFOLFIRINOX) in Participants With CLDN18.2 Positive Metastatic Pancreatic Adenocarcinoma

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.

Read more

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.

Being tested
zolbetuximab, mFOLFIRINOX
Keywords
CLDN18.2 positive metastatic pancreatic adenocarcinoma, mFOLFIRINOX, Claudin 18.2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • zolbetuximabDrug

    Also called IMAB362

    Zolbetuximab will be administered intravenously on day 1 then every two weeks.

  • mFOLFIRINOXDrug

    Modified oxaliplatin, leucovorin, irinotecan and fluorouracil (mFOLFIRINOX) will be administered intravenously within 2 days after administration of zolbetuximab.

Study groups in NCT06396091
Study groupRoleWhat they receive
zolbetuximab and mFOLFIRINOXExperimentalParticipants will receive 1 of 2 dose levels of zolbetuximab in combination with mFOLFIRINOX.
Receives: Drug: zolbetuximab; Drug: mFOLFIRINOX

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence of Dose Limiting Toxicities (DLT)

    A DLT will be defined as any event meeting the DLT criteria occurring during the DLT assessment period that is related to zolbetuximab.

    Measured: Up to 28 days

  2. Safety assessed by Adverse Events (AEs)

    An AE is any untoward medical occurrence in a patient or clinical study participant temporally associated with the use of a study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study intervention. This includes events related to the comparator, if applicable, and events related to the (study) procedures.

    Measured: Up to 16 months

  3. Number of participants with laboratory value abnormalities and/or adverse events (AEs)

    Number of participants with potentially clinically significant laboratory values.

    Measured: Up to 16 months

  4. Number of participants with vital sign abnormalities and/or adverse events (AEs)

    Number of participants with potentially clinically significant vital sign values.

    Measured: Up to 16 months

  5. Number of participants with electrocardiograms (ECG) abnormalities and or adverse events

    Number of participants with potentially clinically significant ECG values.

    Measured: Up to 16 months

  6. Number of participants at each grade of Eastern Cooperative Oncology Group (ECOG) performance status scores

    The ECOG scale will be used to assess performance status. Grades range from 0 (fully active) to 5 (dead). Negative change scores indicate an improvement. Positive scores indicate a decline in performance.

    Measured: Up to 15 months

Secondary outcomes (7)
  1. Pharmacokinetics (PK) of zolbetuximab in serum: End of infusion concentrations

    End of infusion concentrations will be derived from the PK serum samples collected.

    Measured: Up to 1 month

  2. PK of zolbetuximab in serum: Concentration Immediately Prior to Dosing at multiple dosing (Ctrough)

    Ctrough will be derived from the PK serum samples collected.

    Measured: Up to 12 months

  3. Number of participants with positive antidrug antibodies (ADA) to zolbetuximab

    Measured: Up to 15 months

  4. Change from baseline in Cancer Antigen 19-9 (CA 19-9)

    Serum CA19-9 will be assessed.

    Measured: Baseline up to 13 months

  5. Best Overall Response (BOR) Rate

    The BOR is determined once all tumor response data for the participant is available. Participants will be classified by BOR on study as outlined in Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.

    Measured: Up to 15 months

  6. Overall Response Rate (ORR)

    ORR is defined as the proportion of participants with best overall response as confirmed complete response (CR) or partial response based on RECIST v1.1 as assessed by investigator.

    Measured: Up to 15 months

  7. Disease Control Rate (DCR)

    DCR is defined as the proportion of participants with a complete or partial response as assessed by investigator based on RECIST v1.1.

    Measured: Up to 15 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 May 2024
  2. Study start24 Sep 2025
  3. Primary completion31 Dec 2026 (estimated)
  4. Study completion31 Dec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
12 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06396091
Sponsor's protocol ID
8951-CL-5203
Status last verified
Oct 2026
First submitted
30 Apr 2024
Last updated
16 Oct 2026
Results posted
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No: Access to anonymized individual participant level data will not be provided for this trial. Further details on Astellas' data sharing policy can be found at https://www.clinicaltrials.astellas.com/transparency/.
Expanded access
Available

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing zolbetuximab and mFOLFIRINOX in people with Metastatic Pancreatic Adenocarcinoma, run by Astellas Pharma Global Development, Inc. at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 20 inclusion and 32 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 16 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of Dose Limiting Toxicities (DLT) (time frame: Up to 28 days). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2026.

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