Clinical trial · Interventional
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
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 26, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260926-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cachexia | — | UNRESOLVED | — |
| Metastatic Pancreatic Ductal Adenocarcinoma | Pancreatic Ductal Adenocarcinoma | CURATED_BROADER | 0.78 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| placebo | Drug | — | UNRESOLVED |
| ponsegromab | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Double-Blind ponsegromab Treatment lower dose
- description
- ponsegromab 200 mg subcutaneous injection every 4 weeks
- interventionNames
- Drug: ponsegromab
- type
- EXPERIMENTAL
- label
- Double-Blind ponsegromab Treatment higher dose
- description
- ponsegromab 400 mg subcutaneous injection every 4 weeks
- interventionNames
- Drug: ponsegromab
- type
- PLACEBO_COMPARATOR
- label
- Double-Blind Placebo Treatment
- description
- Match placebo subcutaneous injection every 4 weeks
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available