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
- Diseases
- Lung cancer, Pancreatic cancer, Colorectal cancer
- 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
Sites (78)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| St Vincent's Hospital Sydney Coordinator of this site? Confirm its status | Darlinghurst | Australia | Unknown status |
| Peter MacCallum Cancer Centre Coordinator of this site? Confirm its status | Melbourne | Australia | Unknown status |
| Orange Hospital Coordinator of this site? Confirm its status | Orange | Australia | Unknown status |
| Western Health-Sunshine & Footscray Hospitals Coordinator of this site? Confirm its status | St Albans | Australia | Unknown status |
| Complex Oncology Center - Burgas Coordinator of this site? Confirm its status | Burgas | Bulgaria | Unknown status |
| Specialized Hospital for Active Treatment of Oncology - Haskovo Coordinator of this site? Confirm its status | Haskovo | Bulgaria | Unknown status |
| Complex Oncology Center - Ruse EOOD Coordinator of this site? Confirm its status | Rousse | Bulgaria | Unknown status |
| Complex Oncology Center - Shumen Coordinator of this site? Confirm its status | Shumen | Bulgaria | Unknown status |
| MHAT for Women's Health Nadezhda Coordinator of this site? Confirm its status | Sofia | Bulgaria | Unknown status |
| Multiprofile Hospital for Active Treatment Serdika EOOD Coordinator of this site? Confirm its status | Sofia | Bulgaria | Unknown status |
| University Multiprofile Hospital for Active Treatment Sofiamed Coordinator of this site? Confirm its status | Sofia | Bulgaria | Unknown status |
| Complex Oncology Center - Vratsa Coordinator of this site? Confirm its status | Vratsa | Bulgaria | Unknown status |
| CIUSSS- saguenay-Lac-Saint-Jean Coordinator of this site? Confirm its status | Chicoutimi | Canada | Unknown status |
| The Ottawa Hospital - General Campus Coordinator of this site? Confirm its status | Ottawa | Canada | Unknown status |
| Centre intégré de santé et de services sociaux du Bas Saint-Laurent- Hôpital régional de Rimouski Coordinator of this site? Confirm its status | Rimouski | Canada | Unknown status |
| Princess Margaret Cancer Centre Coordinator of this site? Confirm its status | Toronto | Canada | Unknown status |
| Peking University First Hospital Coordinator of this site? Confirm its status | Beijing | China | Unknown status |
| Changzhou No.2 People's Hospital Coordinator of this site? Confirm its status | Changzhou | China | Unknown status |
| Sir Run Run Shaw Hospital of Zhejiang University School of Medicine Coordinator of this site? Confirm its status | Hangzhou | China | Unknown status |
| Qilu Hospital of Shandong University Coordinator of this site? Confirm its status | Jinan | China | Unknown status |
| The First Affiliated Hospital of NanChang University Coordinator of this site? Confirm its status | Nanchang | China | Unknown status |
| Shanghai Changhai Hospital Coordinator of this site? Confirm its status | Shanghai | China | Unknown status |
| Shanxi Provincial Cancer Hospital Coordinator of this site? Confirm its status | Taiyuan | China | Unknown status |
| The 2nd Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical University Coordinator of this site? Confirm its status | Wenzhou | China | Unknown status |
| Tongji Hospital, Tongji Medical College of Huazhong University of Science and Technology Coordinator of this site? Confirm its status | Wuhan | China | Unknown status |
| Henan Cancer Hospital Coordinator of this site? Confirm its status | Zhengzhou | China | Unknown status |
| Institut Català d'Oncología L'Hospitalet Coordinator of this site? Confirm its status | L'Hospitalet de Llobregat | Spain | Unknown status |
| Hospital Universitario HM Sanchinarro Coordinator of this site? Confirm its status | Madrid | Spain | Unknown status |
| Hospital Son Llatzer Coordinator of this site? Confirm its status | Palma | Spain | Unknown status |
| Hospital Universitari General de Catalunya Coordinator of this site? Confirm its status | Sant Cugat del Vallès | Spain | Unknown status |
| Hospital Universitari i Politécnic La Fe Coordinator of this site? Confirm its status | Valencia | Spain | Unknown status |
| Fundación Instituto Valenciano de Oncología Coordinator of this site? Confirm its status | Valencia | Spain | Unknown status |
| Semmelweis Egyetem Coordinator of this site? Confirm its status | Budapest | Hungary | Unknown status |
| Orszagos Koranyi Pulmonologiai Intezet Coordinator of this site? Confirm its status | Budapest | Hungary | Unknown status |
| Bacs-Kiskun Varmegyei Oktatokorhaz Coordinator of this site? Confirm its status | Kecskemét | Hungary | Unknown status |
| Jász-Nagykun-Szolnok Megyei Hetényi Géza Kórház Coordinator of this site? Confirm its status | Szolnok | Hungary | Unknown status |
| Hyogo Cancer Center Coordinator of this site? Confirm its status | Akashi | Japan | Unknown status |
| National Cancer Center Hospital East Coordinator of this site? Confirm its status | Kashiwa | Japan | Unknown status |
| University Hospital Kyoto Prefectural University of Medicine Coordinator of this site? Confirm its status | Kyoto | Japan | Unknown status |
| National Hospital Organization Shikoku Cancer Center Coordinator of this site? Confirm its status | Matsuyama | Japan | Unknown status |
| Shizuoka Cancer Center Coordinator of this site? Confirm its status | Nagaizumi-chō | Japan | Unknown status |
| Aichi Cancer Center Hospital Coordinator of this site? Confirm its status | Nagoya | Japan | Unknown status |
| The Cancer Institute Hospital of JFCR Coordinator of this site? Confirm its status | Tokyo | Japan | Unknown status |
| Kanagawa Cancer Center Coordinator of this site? Confirm its status | Yokohama | Japan | Unknown status |
| Regionalny Szpital Specjalistyczny im. Dr. Wladyslawa Bieganskiego Coordinator of this site? Confirm its status | Grudziądz | Poland | Unknown status |
| NZOZ "Vegamed" Coordinator of this site? Confirm its status | Katowice | Poland | Unknown status |
| Centrum Badań Klinicznych Jagiellońskie Centrum Innowacji sp. z o.o. Coordinator of this site? Confirm its status | Krakow | Poland | Unknown status |
| Specjalistyczna Praktyka Lekarska Slawomir Mandziuk Coordinator of this site? Confirm its status | Lublin | Poland | Unknown status |
| Fakultna nemocnica s poliklinikou F.D.Roosevelta Banska Bystrica Coordinator of this site? Confirm its status | Banská Bystrica | Slovakia | Unknown status |
| Narodny onkologicky ustav, II. Onkologicka klinika LFUK a NOU Coordinator of this site? Confirm its status | Bratislava | Slovakia | Unknown status |
| Univerzitná nemocnica Bratislava - Nemocnica Ružinov Coordinator of this site? Confirm its status | Bratislava | Slovakia | Unknown status |
| Fakultna nemocnica s poliklinikou Nove Zamky Coordinator of this site? Confirm its status | Nové Zámky | Slovakia | Unknown status |
| Nemocnica na okraji mesta, n.o. Coordinator of this site? Confirm its status | Partizánske | Slovakia | Unknown status |
| Fakultna nemocnica Trnava Coordinator of this site? Confirm its status | Trnava | Slovakia | Unknown status |
| Kaohsiung Medical University Chung-Ho Memorial Hospital Coordinator of this site? Confirm its status | Kaohsiung City | Taiwan | Unknown status |
| China Medical University Hospital Coordinator of this site? Confirm its status | Taichung | Taiwan | Unknown status |
| National Cheng Kung University Hospital Coordinator of this site? Confirm its status | Tainan | Taiwan | Unknown status |
| Chi Mei Hospital - Liouying Branch Coordinator of this site? Confirm its status | Tainan | Taiwan | Unknown status |
| Chang Gung Medical Foundation-Linkou Branch Coordinator of this site? Confirm its status | Taoyuan | Taiwan | Unknown status |
| Pacific Cancer Medical Center INC Coordinator of this site? Confirm its status | Anaheim | United States | Unknown status |
| Pennington Biomedical Research Center Coordinator of this site? Confirm its status | Baton Rouge | United States | Unknown status |
| Beverly Hills Cancer Center Coordinator of this site? Confirm its status | Beverly Hills | United States | Unknown status |
| Bozeman Health Deaconess Hospital Coordinator of this site? Confirm its status | Bozeman | United States | Unknown status |
| CARTI Conway Coordinator of this site? Confirm its status | Conway | United States | Unknown status |
| The University of Texas MD Anderson Cancer Center Coordinator of this site? Confirm its status | Houston | United States | Unknown status |
| IU Health Arnett Cancer Center Coordinator of this site? Confirm its status | Lafayette | United States | Unknown status |
| CARTI Cancer Center Coordinator of this site? Confirm its status | Little Rock | United States | Unknown status |
| Tandem Clinical Research Coordinator of this site? Confirm its status | Marrero | United States | Unknown status |
| CARTI North Little Rock Coordinator of this site? Confirm its status | North Little Rock | United States | Unknown status |
| Oregon Health and Science University: Center for Health and Healing 2 Coordinator of this site? Confirm its status | Portland | United States | Unknown status |
| Oregon Health and Science University Coordinator of this site? Confirm its status | Portland | United States | Unknown status |
| Oregon Health and Science University: Center for Health and Healing 1 Coordinator of this site? Confirm its status | Portland | United States | Unknown status |
| Emad Ibrahim, MD, Inc. Coordinator of this site? Confirm its status | Redlands | United States | Unknown status |
| Carta - Clinical Associates in Research Therapeutics of America, LLC Coordinator of this site? Confirm its status | San Antonio | United States | Unknown status |
| Providence Medical Foundation Coordinator of this site? Confirm its status | Santa Rosa | United States | Unknown status |
| Virginia Mason Medical Center Coordinator of this site? Confirm its status | Seattle | United States | Unknown status |
| CARTI Stuttgart Coordinator of this site? Confirm its status | Stuttgart | United States | Unknown status |
| Wenatchee Valley Hospital Coordinator of this site? Confirm its status | Wenatchee | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.