Clinical trial · Interventional
Study of the Efficacy and Safety of Ponsegromab in Patients With Cancer, Cachexia and Elevated GDF-15
A PHASE 2, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO INVESTIGATE THE EFFICACY, SAFETY AND TOLERABILITY OF PONSEGROMAB IN PATIENTS WITH CANCER, CACHEXIA, AND ELEVATED CONCENTRATIONS OF GDF-15, FOLLOWED BY AN OPTIONAL OPEN-LABEL TREATMENT PERIOD (PROACC -1)
NCT05546476CI-TRIAL-00113529PROACC-1completedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Study to evaluate the efficacy, safety and tolerability of ponsegromab compared to placebo in patients with cancer, cachexia, and elevated GDF 15.
Conditions
Conditions (6)
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 | — |
| Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
| Fatigue | — | UNRESOLVED | — |
| Loss of Appetite | — | UNRESOLVED | — |
| Non-small Cell Lung Cancer | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
| Pancreatic Cancer | Malignant Pancreatic Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Placebo for ponsegromab | Drug | — | UNRESOLVED |
| ponsegromab | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (4)
- type
- EXPERIMENTAL
- label
- Double-Blind ponsegromab Treatment low dose followed by Open Label ponsegromab Treatment
- description
- ponsegromab low dose subcutaneous injection every 4 weeks
- interventionNames
- Drug: ponsegromab
- type
- PLACEBO_COMPARATOR
- label
- Double-Blind Placebo Treatment followed by Open-Label ponsegromab Treatment
- description
- Match placebo subcutaneous injection every 4 weeks
- interventionNames
- Drug: Placebo for ponsegromab
- type
- EXPERIMENTAL
- label
- Double-Blind ponsegromab Treatment medium dose followed by Open Label ponsegromab Treatment
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Key Inclusion Criteria: * Documented active diagnosis of non-small cell lung, pancreatic, colorectal cancer * Cachexia defined by Fearon criteria of weight loss * Serum GDF-15 concentrations * Signed informed consent * ECOG PS ≤3 with life expectancy of at least 4 months to be able to complete Part A. 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 liver function * renal disease requiring dialysis
References
Publications (2)
- DERIVEDGroarke JD, Crawford J, Collins SM, Lubaczewski S, Roeland EJ, Naito T, Hendifar AE, Fallon M, Takayama K, Asmis T, Dunne RF, Karahanoglu I, Northcott CA, Harrington MA, Rossulek M, Qiu R, Saxena AR. Ponsegromab for the Treatment of Cancer Cachexia. N Engl J Med. 2024 Dec 19;391(24):2291-2303. doi: 10.1056/NEJMoa2409515. Epub 2024 Sep 14. PMID 39282907
- DERIVEDGroarke JD, Crawford J, Collins SM, Lubaczewski SL, Breen DM, Harrington MA, Jacobs I, Qiu R, Revkin J, Rossulek MI, Saxena AR. Phase 2 study of the efficacy and safety of ponsegromab in patients with cancer cachexia: PROACC-1 study design. J Cachexia Sarcopenia Muscle. 2024 Jun;15(3):1054-1061. doi: 10.1002/jcsm.13435. Epub 2024 Mar 18. PMID 38500292