187 Participants Needed

Ponsegromab for Cachexia

(PROACC-1 Trial)

Recruiting at 127 trial locations
PC
Overseen ByPfizer CT.gov Call Center
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: Pfizer
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests Ponsegromab, a new drug, on cancer patients who are losing weight and have high GDF 15 levels. The drug aims to lower GDF 15 to improve appetite and reduce weight loss.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What is known about the safety of Ponsegromab in humans?

Ponsegromab has been studied for safety in a 24-week trial involving adults with advanced cancer and cachexia. This study was designed to assess its safety and tolerability, indicating that it has undergone initial safety evaluations in humans.12345

How is the drug Ponsegromab unique in treating cachexia?

Ponsegromab is unique because it is a monoclonal antibody (a type of protein made in the lab to bind to specific substances in the body) that targets and blocks GDF-15, a protein associated with cachexia in cancer patients, which is different from other treatments that focus on stimulating appetite or increasing weight.12678

Who Is on the Research Team?

PC

Pfizer CT.gov Call Center

Principal Investigator

Pfizer

Are You a Good Fit for This Trial?

This trial is for adults with non-small cell lung, pancreatic, or colorectal cancer who are experiencing cachexia (significant weight loss due to illness) as defined by Fearon criteria. They must have elevated GDF-15 protein levels and be able to consent to the study. People with tube feedings, other causes of cachexia, severe allergies to monoclonal antibodies, or poor kidney/liver function cannot join.

Inclusion Criteria

Serum GDF-15 concentrations
Signed informed consent
I have significant weight loss and muscle loss.
See 6 more

Exclusion Criteria

My weight loss is not due to cancer.
I am currently on tube feedings or IV nutrition.
My kidney or liver is not working properly.
See 2 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive ponsegromab or placebo subcutaneously every 4 weeks for 12 weeks

12 weeks
3 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Open-label extension (optional)

Participants may opt into continuation of ponsegromab treatment every 4 weeks for up to one year

Up to 1 year

What Are the Treatments Tested in This Trial?

Interventions

  • Placebo for Ponsegromab
  • Ponsegromab
Trial Overview The trial is testing the effectiveness and safety of a drug called Ponsegromab in comparison to a placebo in patients suffering from cancer-related cachexia. Participants will either receive Ponsegromab or a placebo without knowing which one they're getting.
How Is the Trial Designed?
4Treatment groups
Experimental Treatment
Placebo Group
Group I: Double-Blind ponsegromab Treatment medium dose followed by Open Label ponsegromab TreatmentExperimental Treatment1 Intervention
ponsegromab medium dose subcutaneous injection every 4 weeks
Group II: Double-Blind ponsegromab Treatment low dose followed by Open Label ponsegromab TreatmentExperimental Treatment1 Intervention
ponsegromab low dose subcutaneous injection every 4 weeks
Group III: Double-Blind ponsegromab Treatment high dose followed by Open Label ponsegromab TreatmentExperimental Treatment1 Intervention
ponsegromab high dose subcutaneous injection every 4 weeks
Group IV: Double-Blind Placebo Treatment followed by Open-Label ponsegromab TreatmentPlacebo Group1 Intervention
Match placebo subcutaneous injection every 4 weeks

Find a Clinic Near You

Who Is Running the Clinical Trial?

Pfizer

Lead Sponsor

Trials
4,712
Recruited
50,980,000+
Known For
Vaccine Innovations
Top Products
Viagra, Zoloft, Lipitor, Prevnar 13

Albert Bourla

Pfizer

Chief Executive Officer since 2019

PhD in Biotechnology of Reproduction, Aristotle University of Thessaloniki

Patrizia Cavazzoni profile image

Patrizia Cavazzoni

Pfizer

Chief Medical Officer

MD from McGill University

Published Research Related to This Trial

In a study of 13 patients with advanced cancer cachexia, a combination of the anabolic β2-agonist formoterol and the appetite stimulant megestrol acetate was found to be safe and well tolerated over an 8-week period, with few adverse reactions reported.
Of the patients who completed the treatment, 86% showed significant improvements in muscle size and/or function, indicating that this combination therapy could effectively address muscle loss in cancer cachexia and should be explored further in larger trials.
Phase I/II trial of formoterol fumarate combined with megestrol acetate in cachectic patients with advanced malignancy.Greig, CA., Johns, N., Gray, C., et al.[2021]
In a phase Ib study involving 10 patients with advanced cancer and cachexia, ponsegromab was well tolerated with no significant adverse effects, indicating its safety for use in this population.
Ponsegromab effectively reduced serum GDF-15 levels and led to an average weight increase of 4.63 kg (about 6.6% from baseline) over 12 weeks, along with improvements in physical activity and quality of life, suggesting its potential efficacy in treating cachexia.
A Phase 1b First-In-Patient Study Assessing the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Ponsegromab in Participants with Cancer and Cachexia.Crawford, J., Calle, RA., Collins, SM., et al.[2023]

Citations

Phase I/II trial of formoterol fumarate combined with megestrol acetate in cachectic patients with advanced malignancy. [2021]
A Phase 1b First-In-Patient Study Assessing the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Ponsegromab in Participants with Cancer and Cachexia. [2023]
Pilot clinical trial of macimorelin to assess safety and efficacy in patients with cancer cachexia. [2023]
Phase II trial of mirtazapine for cancer-related cachexia and anorexia. [2018]
Current Therapeutic Targets in Cancer Cachexia: A Pathophysiologic Approach. [2023]
Studies of high-dose megestrol acetate: potential applications in cachexia. [2018]
Therapeutic potential of anamorelin, a novel, oral ghrelin mimetic, in patients with cancer-related cachexia: a multicenter, randomized, double-blind, crossover, pilot study. [2022]
Pharmacological treatment of cachexia: any progress? [2017]
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