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Ponsegromab plus chemotherapy for adults with metastatic pancreatic cancer and cachexia

A Phase 2b/3, Randomized, Double-Blind Study to Investigate the Efficacy, Safety, and Tolerability of Ponsegromab (PF-06946860) Compared With Placebo Both With Background First-Line Chemotherapy in Adult Participants With Cachexia and Metastatic Pancreatic Ductal Adenocarcinoma

Phase2; Phase3 Interventional Pfizer · NCT06989437

This trial tests whether adding the monoclonal antibody ponsegromab to first-line chemotherapy helps adults with metastatic pancreatic cancer who are losing weight and have fatigue from cachexia.

Quick facts

PhasePhase2; Phase3
Study typeInterventional
Enrollment982 (estimated)
Ages18 Years and up
SexAll
SponsorPfizer Industry-sponsored
Drugs / interventionschemotherapy, ponsegromab
Locations129 sites (Birmingham, Alabama and 128 other locations)
Trial IDNCT06989437 on ClinicalTrials.gov

What this trial studies

This is a Phase 2b/3, randomized, double-blind, multicenter study comparing two doses of ponsegromab plus standard first-line chemotherapy versus placebo plus chemotherapy in adults with metastatic pancreatic ductal adenocarcinoma and cachexia. Eligible participants must complete an initial cycle of nab-paclitaxel/gemcitabine or two cycles of FOLFIRINOX before randomization and are assigned 1:1:1 to one of the two ponsegromab doses or placebo. Ponsegromab or placebo is given subcutaneously every four weeks alongside the participant's planned chemotherapy, with a double-blind period followed by an optional open-label extension. The trial measures safety, tolerability, and clinical efficacy outcomes related to cancer and cachexia.

Who should consider this trial

Good fit: Adults with documented metastatic pancreatic ductal adenocarcinoma who meet Fearon criteria for cachexia, have ECOG performance status 0–1, have life expectancy ≥4 months, and have completed the specified initial cycle(s) of first-line chemotherapy are ideal candidates.

Not a fit: Patients with cachexia from other causes, active reversible causes of poor intake, current heart failure or LVEF <50%, those on tube feeds or parenteral nutrition, or with prior severe allergic reactions to monoclonal antibodies are unlikely to benefit or be eligible.

Why it matters

Potential benefit: If successful, adding ponsegromab could slow or reverse cancer-related weight loss and fatigue, improving quality of life and potentially treatment tolerance.

How similar studies have performed: Previous pharmacologic approaches to cancer cachexia have shown mixed or modest results, and monoclonal antibody therapy for cachexia remains a relatively novel approach with limited prior clinical success.

Eligibility criteria

Show full inclusion / exclusion 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 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

Where this trial is running

Birmingham, Alabama and 128 other locations

+79 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions CachexiaMetastatic Pancreatic Ductal Adenocarcinomapancreatic cancermetastatic cancercanceranorexiacachexiaweight loss
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.