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NCT05546476CompletedPhase 2

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)

Source: ClinicalTrials.gov · Last updated 3 Jun 2026

Brief summary (registry, in English)

Study to evaluate the efficacy, safety and tolerability of ponsegromab compared to placebo in patients with cancer, cachexia, and elevated GDF 15.

Status (registry)
Completed
Phase (registry)
Phase 2
Study type
Interventional
Enrollment
187 (actual)
First submitted
12 Aug 2022
Start date
21 Nov 2022
Primary completion date
13 Mar 2024
Lead sponsor
Pfizer
NCT number
NCT05546476
EU CT number
2023-510446-24-00

What you commit to

  • Study type: Interventional · Phase 2
  • Participants enrolled: 187
  • From 21 Nov 2022 to the primary completion date, 13 Mar 2024
  • 78 sites in 11 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Receiving tube feedings or parenteral nutrition at the time of Screening or Randomization.

Other illness

  • History of allergic or anaphylactic reaction to any therapeutic or diagnostic monoclonal antibody.
  • renal disease requiring dialysis

Other

  • Current active reversible causes of decreased food intake.
  • Cachexia caused by other reasons.
  • inadequate liver function

Who the study is looking for

  • 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.

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (78)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
St Vincent's Hospital Sydney
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DarlinghurstAustraliaUnknown status
Peter MacCallum Cancer Centre
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MelbourneAustraliaUnknown status
Orange Hospital
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OrangeAustraliaUnknown status
Western Health-Sunshine & Footscray Hospitals
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St AlbansAustraliaUnknown status
Complex Oncology Center - Burgas
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BurgasBulgariaUnknown status
Specialized Hospital for Active Treatment of Oncology - Haskovo
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HaskovoBulgariaUnknown status
Complex Oncology Center - Ruse EOOD
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RousseBulgariaUnknown status
Complex Oncology Center - Shumen
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ShumenBulgariaUnknown status
MHAT for Women's Health Nadezhda
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SofiaBulgariaUnknown status
Multiprofile Hospital for Active Treatment Serdika EOOD
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SofiaBulgariaUnknown status
University Multiprofile Hospital for Active Treatment Sofiamed
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SofiaBulgariaUnknown status
Complex Oncology Center - Vratsa
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VratsaBulgariaUnknown status
CIUSSS- saguenay-Lac-Saint-Jean
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ChicoutimiCanadaUnknown status
The Ottawa Hospital - General Campus
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OttawaCanadaUnknown status
Centre intégré de santé et de services sociaux du Bas Saint-Laurent- Hôpital régional de Rimouski
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RimouskiCanadaUnknown status
Princess Margaret Cancer Centre
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TorontoCanadaUnknown status
Peking University First Hospital
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BeijingChinaUnknown status
Changzhou No.2 People's Hospital
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ChangzhouChinaUnknown status
Sir Run Run Shaw Hospital of Zhejiang University School of Medicine
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HangzhouChinaUnknown status
Qilu Hospital of Shandong University
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JinanChinaUnknown status
The First Affiliated Hospital of NanChang University
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NanchangChinaUnknown status
Shanghai Changhai Hospital
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ShanghaiChinaUnknown status
Shanxi Provincial Cancer Hospital
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TaiyuanChinaUnknown status
The 2nd Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical University
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WenzhouChinaUnknown status
Tongji Hospital, Tongji Medical College of Huazhong University of Science and Technology
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WuhanChinaUnknown status
Henan Cancer Hospital
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ZhengzhouChinaUnknown status
Institut Català d'Oncología L'Hospitalet
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L'Hospitalet de LlobregatSpainUnknown status
Hospital Universitario HM Sanchinarro
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MadridSpainUnknown status
Hospital Son Llatzer
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PalmaSpainUnknown status
Hospital Universitari General de Catalunya
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Sant Cugat del VallèsSpainUnknown status
Hospital Universitari i Politécnic La Fe
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ValenciaSpainUnknown status
Fundación Instituto Valenciano de Oncología
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ValenciaSpainUnknown status
Semmelweis Egyetem
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BudapestHungaryUnknown status
Orszagos Koranyi Pulmonologiai Intezet
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BudapestHungaryUnknown status
Bacs-Kiskun Varmegyei Oktatokorhaz
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KecskemétHungaryUnknown status
Jász-Nagykun-Szolnok Megyei Hetényi Géza Kórház
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SzolnokHungaryUnknown status
Hyogo Cancer Center
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AkashiJapanUnknown status
National Cancer Center Hospital East
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KashiwaJapanUnknown status
University Hospital Kyoto Prefectural University of Medicine
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KyotoJapanUnknown status
National Hospital Organization Shikoku Cancer Center
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MatsuyamaJapanUnknown status
Shizuoka Cancer Center
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Nagaizumi-chōJapanUnknown status
Aichi Cancer Center Hospital
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NagoyaJapanUnknown status
The Cancer Institute Hospital of JFCR
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TokyoJapanUnknown status
Kanagawa Cancer Center
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YokohamaJapanUnknown status
Regionalny Szpital Specjalistyczny im. Dr. Wladyslawa Bieganskiego
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GrudziądzPolandUnknown status
NZOZ "Vegamed"
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KatowicePolandUnknown status
Centrum Badań Klinicznych Jagiellońskie Centrum Innowacji sp. z o.o.
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KrakowPolandUnknown status
Specjalistyczna Praktyka Lekarska Slawomir Mandziuk
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LublinPolandUnknown status
Fakultna nemocnica s poliklinikou F.D.Roosevelta Banska Bystrica
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Banská BystricaSlovakiaUnknown status
Narodny onkologicky ustav, II. Onkologicka klinika LFUK a NOU
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BratislavaSlovakiaUnknown status
Univerzitná nemocnica Bratislava - Nemocnica Ružinov
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BratislavaSlovakiaUnknown status
Fakultna nemocnica s poliklinikou Nove Zamky
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Nové ZámkySlovakiaUnknown status
Nemocnica na okraji mesta, n.o.
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PartizánskeSlovakiaUnknown status
Fakultna nemocnica Trnava
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TrnavaSlovakiaUnknown status
Kaohsiung Medical University Chung-Ho Memorial Hospital
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Kaohsiung CityTaiwanUnknown status
China Medical University Hospital
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TaichungTaiwanUnknown status
National Cheng Kung University Hospital
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TainanTaiwanUnknown status
Chi Mei Hospital - Liouying Branch
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TainanTaiwanUnknown status
Chang Gung Medical Foundation-Linkou Branch
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TaoyuanTaiwanUnknown status
Pacific Cancer Medical Center INC
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AnaheimUnited StatesUnknown status
Pennington Biomedical Research Center
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Baton RougeUnited StatesUnknown status
Beverly Hills Cancer Center
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Beverly HillsUnited StatesUnknown status
Bozeman Health Deaconess Hospital
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BozemanUnited StatesUnknown status
CARTI Conway
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ConwayUnited StatesUnknown status
The University of Texas MD Anderson Cancer Center
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HoustonUnited StatesUnknown status
IU Health Arnett Cancer Center
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LafayetteUnited StatesUnknown status
CARTI Cancer Center
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Little RockUnited StatesUnknown status
Tandem Clinical Research
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MarreroUnited StatesUnknown status
CARTI North Little Rock
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North Little RockUnited StatesUnknown status
Oregon Health and Science University: Center for Health and Healing 2
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PortlandUnited StatesUnknown status
Oregon Health and Science University
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PortlandUnited StatesUnknown status
Oregon Health and Science University: Center for Health and Healing 1
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PortlandUnited StatesUnknown status
Emad Ibrahim, MD, Inc.
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RedlandsUnited StatesUnknown status
Carta - Clinical Associates in Research Therapeutics of America, LLC
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San AntonioUnited StatesUnknown status
Providence Medical Foundation
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Santa RosaUnited StatesUnknown status
Virginia Mason Medical Center
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SeattleUnited StatesUnknown status
CARTI Stuttgart
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StuttgartUnited StatesUnknown status
Wenatchee Valley Hospital
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WenatcheeUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.