A Study of Zolbetuximab (IMAB362) in Adults With Pancreatic Cancer

Condition(s) studied

Investigational drug(s) / intervention(s)

zolbetuximab: Administered as an intravenous infusion.

nab-paclitaxel: Administered as an intravenous infusion

gemcitabine: Administered as an intravenous infusion

Study summary

Zolbetuximab is being studied as a treatment for people with pancreatic cancer. Most people with pancreatic cancer have a protein called Claudin 18.2 (CLDN18.2) in their tumor. Zolbetuximab is thought to work by attaching to CLDN 18.2 in their tumor. This switches on the body's immune system to attack the tumor. Zolbetuximab is a potential treatment for people with pancreatic cancer.

There is an unmet medical need to treat people with pancreatic cancer. This study will help find the dose of zolbetuximab to be used with chemotherapy and provide more information on this treatment in adults with metastatic pancreatic cancer. The study is currently ongoing globally. People in this study will be treated with either zolbetuximab and chemotherapy or chemotherapy by itself.

The study's main aims are to find a suitable dose of zolbetuximab to be used with chemotherapy in the second part of this study, to check if zolbetuximab and chemotherapy compared to chemotherapy by itself can improve the survival of people with pancreatic cancer, and to check the safety of zolbetuximab when given with chemotherapy and how well people cope with medical problems during the study.

Adults with metastatic pancreatic cancer can take part. Their cancer is metastatic, has the CLDN18.2 marker in a tumor sample and has not previously been treated with chemotherapy. Metastatic means the cancer has spread to other parts of the body. People cannot take part are if they have recently had radiotherapy and have not recovered, need to take medicines to suppress their immune system, have history of nervous system metastases from their pancreatic cancer, or they have other active cancers that need treatment. People who have a specific heart condition or infections also cannot take part.

This study will be in 2 parts. Part 1 is called the Safety Lead-in Phase. Groups of people will receive 1 of 2 different doses of zolbetuximab: a lower dose or a higher dose, both together with chemotherapy. A medical expert panel will check the results and decide the dose to use in Part 2.

Part 2 is called the Randomization Phase. People will be put in 1 of 2 groups by chance and will be given different treatments either zolbetuximab and chemotherapy or chemotherapy by itself. The chance of receiving zolbetuximab and chemotherapy is twice as high as receiving chemotherapy by itself. In both parts of the study, zolbetuximab and chemotherapy or chemotherapy by itself will be given through a vein. This is called an infusion. Each treatment cycle is 4 weeks (28 days) long and people will have either 2 infusions of zolbetuximab and 3 infusions of chemotherapy or 3 infusions of chemotherapy by itself during each treatment cycle. People will visit the clinic on certain days during their treatment. The study doctors will check for any medical problems from zolbetuximab. Also, people in the study will have a health check including blood tests. On some visits they will also have scans to check for any changes in their cancer. Tumor samples will be taken before treatment if a previous sample is not available. People will have the option of giving a tumor sample after treatment has finished. People will visit the clinic after they stop treatment. They will be asked about any medical problems and will have a health check including blood tests. The number of visits and checks done at each visit will depend on the health of each person and whether they completed their treatment or not.

Astellas is terminating the zolbetuximab pancreatic development program from Dec 2025 (following the final OS analysis in Oct 2025). Active subjects may remain on treatment if the investigator determines they are receiving benefit from it. The Survival follow-up period is no longer required.

Eligibility

Primary outcome measure(s)

• Dose Limiting Toxicities (DLT) - (safety lead in) — Up to 28 days
  Incidence of dose limiting toxicities.
• Overall Survival (OS) — Up to 79 months
  OS is defined as the time from the date of randomization until the date of death from any cause.
• Safety assessed by Adverse Events (AEs) — From signing inform consent form until 90 days after the last dose of the study drug (Up to 82 months)
  An AE is any untoward medical occurrence in a subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. 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 a medicinal product.
• Safety assessed by incidence of serious adverse events (SAE) — From signing inform consent form until 90 days after the last dose of the study drug (Up to 82 months)
  Adverse Event (AE) is considered "serious" if the investigator or sponsor view any of the following outcomes: Death, life-threatening, persistent or significant disability/incapacity, congenital anomaly or birth defect, hospitalization, or medically important event.
• Safety assessed by incidence of treatment emergent adverse events (TEAE) — From first dose up to 30 days after last dose (Up to 80 months)
  Treatment Emergent Adverse Event (TEAE) is defined as any AE which starts, or worsens, after the first dose of study drug through 30 days after the last dose of study drug.
• Number of participants with laboratory value abnormalities and/or adverse events (AEs) — From first dose up to 30 days after last dose (Up to 80 months)
  Number of participants with potentially clinically significant laboratory values.
• Number of participants with vital sign abnormalities and /or adverse events (AEs) — From first dose up to 30 days after last dose (Up to 80 months)
  Number of participants with potentially clinically significant vital sign values.
• Number of participants with electrocardiograms (ECG) abnormalities and or adverse events — From first dose up to 30 days after last dose (Up to 80 months)
  12-lead ECGs will be recorded. Prior to the ECG, participants should rest in supine position for 10 minutes. ECGs will be read and assessed locally.
• Number of participants with Eastern Cooperative Oncology Group (ECOG) performance status abnormalities and or adverse events — From first dose up to 30 days after last dose (Up to 80 months)
  Number of participants with potentially clinically significant ECOG performance status values. ECOG grades 0-5, where 0 = Fully active, able to carry on all pre-disease performance without restriction; 1 = Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work; 2 = Ambulatory and capable of all self-care but unable to carry out any work activities. Up and about more than 50% of waking hours; 3 = Capable of only limited self-care, confined to bed or chair more than 50% of waking hours; 4 = Completely disabled. Cannot carry on any self-care. Totally confined to bed or chair and 5 = Dead.

Trial sites (136)

+ 96 more sites — see the full list on the official registry below.

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