Completed

PROACC-1A 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)

0 criteria met from your profileSee at a glance how your profile meets each eligibility criteria.
What is being tested

ponsegromab

+ Placebo for ponsegromab

Drug
Who is being recruted

Anorexia+30

+ Body Weight

+ Body Weight Changes

Over 18 Years
+6 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Placebo-ControlledPhase 2
Interventional
Study Start: November 2022
See protocol details

Summary

Principal SponsorPfizer
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: November 21, 2022

Actual date on which the first participant was enrolled.

A 12 week double blind study to evaluate the efficacy, safety and tolerability of ponsegromab compared to placebo in patients with cancer, cachexia, and elevated GDF 15. During the initial 12-week treatment period (Part A), a total of 3 doses of ponsegromab or placebo will be administered 4 weeks apart subcutaneously. Each dose contains two injections. Part B is an optional open-label treatment period consisting of ponsegromab administered every 4 weeks subcutaneously for up to one year. Part B does not include placebo. Assessments include: * Body weight measurements * Measure the impact of ponsegromab compared to placebo on physical activity. * Measure the impact of ponsegromab compared to placebo on appetite, fatigue, nausea, vomiting and physical function questionnaires. * Blood samples to evaluate safety and additional endpoints including the amount of study drug in the blood and the effects of the study drug on levels of GDF15 * Up to 3 additional blood samples (two samples during Part A and one sample during Part B, if relevant) in a subset of participants as part of a substudy for more comprehensive assessment of the amount of study drug in the blood and of the effects of the study drug on levels of GDF-15.

Official TitleA 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)
NCT05546476
Principal SponsorPfizer
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

187 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

AnorexiaBody WeightBody Weight ChangesBronchial NeoplasmsCachexiaCarcinoma, BronchogenicCarcinoma, Non-Small-Cell LungColonic DiseasesDigestive System DiseasesDigestive System NeoplasmsEndocrine System DiseasesEndocrine Gland NeoplasmsFatigueGastrointestinal DiseasesGastrointestinal NeoplasmsIntestinal DiseasesIntestinal NeoplasmsLung DiseasesLung NeoplasmsNeoplasmsNeoplasms by SitePancreatic DiseasesPancreatic NeoplasmsRectal DiseasesRespiratory Tract DiseasesRespiratory Tract NeoplasmsSigns and SymptomsSigns and Symptoms, DigestivePathological Conditions, Signs and SymptomsThinnessThoracic NeoplasmsColorectal NeoplasmsWeight Loss

Criteria

6 exclusion criteria prevent from participating
Cachexia caused by other reasons.
Receiving tube feedings or parenteral nutrition at the time of Screening or Randomization.
Current active reversible causes of decreased food intake.
History of allergic or anaphylactic reaction to any therapeutic or diagnostic monoclonal antibody.
Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

4 intervention groups are designated in this study

25% chance of being blinded to the placebo group

Treatment Groups

Group I

Experimental
ponsegromab high dose subcutaneous injection every 4 weeks

Group II

Experimental
ponsegromab low dose subcutaneous injection every 4 weeks

Group III

Experimental
ponsegromab medium dose subcutaneous injection every 4 weeks

Group IV

Placebo
Match placebo subcutaneous injection every 4 weeks

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 78 locations

Suspended

CARTI Conway

Conway, United StatesOpen CARTI Conway in Google Maps
Suspended

CARTI Cancer Center

Little Rock, United States
Suspended

CARTI North Little Rock

North Little Rock, United States
Suspended

CARTI Stuttgart

Stuttgart, United States
Completed78 Study Centers