Study of the Efficacy and Safety of Ponsegromab in Patients With Cancer, Cachexia and Elevated GDF-15

• Status: Not yet recruiting
• Trial end date: 2024-03-15
• Target enrollment: 0
• Participant gender: All

Summary

Study to evaluate the efficacy, safety and tolerability of ponsegromab compared to placebo in patients with cancer, cachexia, and elevated GDF 15.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Pfizer

Criteria

Key Inclusion Criteria:

• Documented diagnosis of non-small cell lung, pancreatic, colorectal cancer

• Cachexia defined by Fearon criteria

• Serum GDF-15 concentrations

• Signed informed consent

Key Exclusion Criteria:

• Receiving tube feedings or parenteral nutrition at the time of Screening or Randomization.

• Current active reversible causes of decreased food intake.

• Cachexia caused by other reasons.

• History of allergic or anaphylactic reaction to any therapeutic or diagnostic monoclonal antibody.

• inadequate renal or liver function