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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
12
Zolbetuximab will be administered intravenously on day 1 then every two weeks.
Modified oxaliplatin, leucovorin, irinotecan and fluorouracil (mFOLFIRINOX) will be administered intravenously within 2 days after administration of zolbetuximab.
Virginia Mason Medical Center
Seattle, Washington, United States
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.
Time frame: Up to 28 days
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.
Time frame: Up to 16 months
Number of participants with laboratory value abnormalities and/or adverse events (AEs)
Number of participants with potentially clinically significant laboratory values.
Time frame: Up to 16 months
Number of participants with vital sign abnormalities and/or adverse events (AEs)
Number of participants with potentially clinically significant vital sign values.
Time frame: Up to 16 months
Number of participants with electrocardiograms (ECG) abnormalities and or adverse events
Number of participants with potentially clinically significant ECG values.
Time frame: Up to 16 months
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.
Time frame: Up to 15 months
Pharmacokinetics (PK) of zolbetuximab in serum: End of infusion concentrations
End of infusion concentrations will be derived from the PK serum samples collected.
Time frame: Up to 1 month
PK of zolbetuximab in serum: Concentration Immediately Prior to Dosing at multiple dosing (Ctrough)
Ctrough will be derived from the PK serum samples collected.
Time frame: Up to 12 months
Number of participants with positive antidrug antibodies (ADA) to zolbetuximab
Time frame: Up to 15 months
Change from baseline in Cancer Antigen 19-9 (CA 19-9)
Serum CA19-9 will be assessed.
Time frame: Baseline up to 13 months
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.
Time frame: Up to 15 months
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.
Time frame: Up to 15 months
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.
Time frame: Up to 15 months
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