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

ID#: NCT06989437

Age: 18 years - 66+

Gender: All

Healthy Subjects: No

Study Phase: Phase 2/Phase 3

Recruitment Status: Recruiting

Start Date: October 03, 2025

End Date: December 10, 2029

Contact Information:
Pfizer CT.gov Call Center
1-800-718-1021
Summary: Study to investigate the efficacy, safety and tolerability of systemic chemotherapy plus ponsegromab versus systemic chemotherapy plus placebo for the first-line treatment in adult participants with cachexia and metastatic pancreatic ductal adenocardinoma.
Eligibility: Key

inclusion Criteria:

- Signed Informed Consent Document

- Documented active diagnosis of metastatic pancreatic ductal adenocarcinoma

- Cachexia defined by Fearon criteria of weight loss

- Completed 1 x 28-day cycle of first-line systemic nab-paclitaxel and gemcitabine chemotherapy or 2 x 14-day cycles of FOLFIRINOX 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

- Any prior or current clinical diagnosis of heart failure, irrespective of left ventricular ejection fraction or New York Heart Association classification

- Left ventricular ejection fraction <50%

- 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
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