Phase 2
N=187
Study of the Efficacy and Safety of Ponsegromab in Patients With Cancer, Cachexia and Elevated GDF-15
Non-small Cell Lung Cancer · Pancreatic Cancer · Colorectal Cancer · Loss of Appetite · Fatigue
Bottom Line
View on ClinicalTrials.gov: NCT05546476 ↗Enrolled (actual)
187
Serious AEs
35.2%
Results posted
Apr 2025
Primary outcome: Primary: Part A: Change From Baseline in Body Weight at Week 12 — NA; NA; NA; NA Kilogram
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- ponsegromab (Drug); Placebo for ponsegromab (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Pfizer
- Primary completion
- Mar 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Part A: Change From Baseline in Body Weight at Week 12 |
NA; NA; NA; NA | — |
| SECONDARY Part A: Change From Baseline in Physical Activity at Week 12 |
-1.42; 51.93; -39.33; -3.37; -37.73; 0.03 | =0.8260 |
| SECONDARY Part A: Change From Baseline in Mean Activity Level During Maximum 6 Minutes at Week 12 |
70.81; -59.46; 794.96; 256.43 | =0.5762 |
| SECONDARY Part A: Change From Baseline in Total Vector Magnitude at Week 12 |
-1919.02; -331.76; -2017.57; 284.15 | =0.0985 |
| SECONDARY Part A: Change From Baseline in Gait at Week 12 |
-0.008; -0.009; -0.012; 0.009; 0.011; 0.011 | =0.5052 |
| SECONDARY Part A: Change From Baseline in Functional Assessment of Anorexia-Cachexia Therapy- Anorexia and Cachexia Subscale (FAACT-ACS) at Week 12 |
0.52; 4.76; 1.15; 4.63 | =0.0114 sig |
| SECONDARY Part A: Change From Baseline in FAACT- 5-Item Anorexia Symptom Scale (5IASS) at Week 12 |
0.15; 2.50; 0.15; 2.45 | =0.0090 sig |
| SECONDARY Part A: Change From Baseline in Cancer-Related Cachexia Symptom Diary (CRCSD) Scores at Week 12: Appetite, Nausea and Physical Fatigue |
-0.23; 0.20; 0.23; 0.69; -0.33; 0.14 | =0.1912 |
| SECONDARY Part A: Median Change From Baseline in CRCSD Scores at Week 12: Vomiting Frequency |
0.00; 0.00; 0.00; 0.00 | — |
| SECONDARY Part A: Number of Participants With Treatment Emergent Adverse Events (TEAE) |
36; 32; 31; 37 | — |
| SECONDARY Part A: Number of Participants With Incidence of Laboratory Test Abnormalities |
26; 24; 29; 28 | — |
| SECONDARY Part A: Number of Participants With Post-Baseline Vital Signs Meeting the Predefined Criteria |
0; 3; 0; 0; 4; 5 | — |
| SECONDARY Part A: Number of Participants With Clinically Significant Echocardiogram (ECG) Abnormalities |
0; 0; 0; 0 | — |
Summary
Study to evaluate the efficacy, safety and tolerability of ponsegromab compared to placebo in patients with cancer, cachexia, and elevated GDF 15.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT05546476). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.