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

Overview

About this study

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.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

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

  • History of heart failure

  • 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

Note: Other protocol defined Inclusion/Exclusion Criteria may apply.

Eligibility last updated 11/7/2025. Questions regarding updates should be directed to the study team contact.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Ryan Carr

Contact us for the latest status

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

Scottsdale/Phoenix, Ariz.

Mayo Clinic principal investigator

Tanios Bekaii-Saab

Contact us for the latest status

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

Jacksonville, Fla.

Mayo Clinic principal investigator

Umair Majeed

Contact us for the latest status

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

More information

Publications

Publications are currently not available