A Study to Learn About the Medicine Ponsegromab in Adults With Cancer of the Pancreas Which Has Spread and Caused Significant Body Weight Loss and Fatigue

Launched by PFIZER · May 16, 2025

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ClinConnect Summary

This clinical trial is studying a new medicine called ponsegromab for adults who have advanced pancreatic cancer that has spread to other parts of the body and is causing significant weight loss and fatigue, a condition known as cachexia. The goal is to see if ponsegromab, when combined with standard chemotherapy, can be more effective than chemotherapy alone in treating these patients.

To participate in this trial, adults aged between 65 and 74 years must have a confirmed diagnosis of metastatic pancreatic ductal adenocarcinoma and experience weight loss due to cachexia. They should also have completed the first cycle of chemotherapy and have a good level of health, with a life expectancy of at least four months. Participants will receive either chemotherapy with ponsegromab or chemotherapy with a placebo (a non-active treatment) and will be monitored for how well they respond to the treatment and any side effects. It's important to note that some individuals, such as those with certain allergies or other serious health issues, may not be eligible to join the study.

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Eligibility criteria

• Key inclusion Criteria:
• • Signed Informed Consent Document
• • Documented active diagnosis of metastatic pancreatic ductal adenocarcinoma
• • Cachexia defined by Fearon criteria of weight loss
• • Completed Cycle 1, first-line systemic chemotherapy and prior to receiving Cycle 2 chemotherapy
• • ECOG PS ≤1 with life expectancy of at least 4 months
• Key Exclusion Criteria:
• • Current active reversible causes of decreased food intake
• • Cachexia caused by other reasons
• • Receiving tube feedings or parenteral nutrition at the time of Screening or Randomization
• • History of allergic or anaphylactic reaction to any therapeutic or diagnostic monoclonal antibody
• • History of allergy or hypersensitivity to any of the chemotherapeutics or any of their excipients
• • Neuroendocrine (carcinoid, islet cell) or acinar pancreatic carcinoma, symptomatic brain metastasis, leptomeningeal disease or other active CNS metastases
• • Inadequate liver function
• • Renal disease requiring dialysis or eGFR \<30 mL/min/1.73m2