A Study to Learn About the Medicine Ponsegromab in Adults With Cancer of the Pancreas Which Has Spread and Caused Significant Body Weight Loss and Fatigue

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
Pfizer
Study ID
NCT06989437
Phase
PHASE2/PHASE3
Status
Recruiting

Conditions

  • Cachexia
  • Metastatic Pancreatic Ductal Adenocarcinoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • ponsegromab — DRUG
    Double-Blind ponsegromab Treatment
  • placebo — DRUG
    Double-Blind placebo Treatment

Study Details

Study to investigate the efficacy, safety and tolerability of systemic chemotherapy plus ponsegromab versus systemic chemotherapy plus placebo for the first-line treatment in adult participants with cachexia and metastatic pancreatic ductal adenocardinoma.

Key Dates

Start date
Oct 3, 2025
Status verified
Jun 2026
Primary completion
Jan 17, 2028
Completion
Dec 10, 2029

Study Design

Enrollment
982 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Double-Blind ponsegromab Treatment lower dose
    ponsegromab 200 mg subcutaneous injection every 4 weeks
  • Experimental: Double-Blind ponsegromab Treatment higher dose
    ponsegromab 400 mg subcutaneous injection every 4 weeks
  • Placebo Comparator: Double-Blind Placebo Treatment
    Match placebo subcutaneous injection every 4 weeks

Primary Outcome Measure

Percent change from baseline in body weight for ponsegromab compared to placebo [ Time Frame: Baseline, Week 12 ]

Central Contacts

Locations (72)

FacilityCityStateZIPSite coordinators
The Kirklin Clinic of UAB HospitalBirminghamAlabama35233-
The University of Alabama at BirminghamBirminghamAlabama35294-
Central Arkansas Radiation Therapy Institute, dba CARTIBryantArkansas72022-
Central Arkansas Radiation Therapy Institute, dba CARTIConwayArkansas72034-
CARTI Cancer CenterLittle RockArkansas72205-
Central Arkansas Radiation Therapy Institute, dba CARTINorth Little RockArkansas72117-
Central Arkansas Radiation Therapy Institute, dba CARTIPine BluffArkansas71603-
UC San Diego Medical Center - EncinitasEncinitasCalifornia92024-
Chao Family Comprehensive Cancer Center and Ambulatory CareIrvineCalifornia92612-
UCI Health - IrvineIrvineCalifornia92612-
UC San Diego Koman Family Outpatient PavilionLa JollaCalifornia92037-
UC San Diego Medical Center - La Jolla (Jacobs Medical Center / Thornton Pavilion)La JollaCalifornia92037-
UC San Diego Moores Cancer CenterLa JollaCalifornia92037-
UC San Diego Sulpizio Cardiovascular CenterLa JollaCalifornia92037-
Cedars-Sinai Cancer at Cedars-Sinai Medical CenterLos AngelesCalifornia90048-
UCLA Department of Medicine - Hematology/OncologyLos AngelesCalifornia90095-
UC Irvine HealthOrangeCalifornia92868-
UC San Diego McGrath Outpatient Pavilion - HillcrestSan DiegoCalifornia92103-
UC San Diego Medical Center - Bankers HillSan DiegoCalifornia92101-
UC San Diego Medical Center - HillcrestSan DiegoCalifornia92103-
UC San Diego Medical Center - Rancho BernardoSan DiegoCalifornia92127-
UCLA Hematology/Oncology - Santa MonicaSanta MonicaCalifornia90404-
Providence Medical FoundationSanta RosaCalifornia95403-
UC San Diego Medical Center - VistaVistaCalifornia92081-
Georgetown University Medical CenterWashington D.C.District of Columbia20007-
Georgetown University Medical Center - Department of Pharmacy, Oncology PharmacyWashington D.C.District of Columbia20007-
University Cancer & Blood Center, LLCAthensGeorgia30607-
Cardiology Associates, Inc‘AieaHawaii96701-
Invision, LLCHonoluluHawaii96813-
University of Hawaii Cancer CenterHonoluluHawaii96813-
Cancer Care Specialists of IllinoisDecaturIllinois62526-
Decatur Memorial HospitalDecaturIllinois62526-
Hope and Healing Clinical Research LLCHinsdaleIllinois60521-
Hope and Healing Clinical Research LLC New Lenox- Research DepartmentNew LenoxIllinois60451-
Cancer Care Specialists of Illinois - Cancer Care Center of O'FallonO'FallonIllinois62269-
United Imaging ConsultantsLenexaKansas66215-
MidAmerica Cancer Care- American Oncology PartnersMerriamKansas66204-
University of Kentucky Healthcare - Markey Cancer CenterLexingtonKentucky40536-
University of Kentucky Medical CenterLexingtonKentucky40536-
University of Kentucky Research FoundationLexingtonKentucky40506-
University of Kentucky, Markey Cancer Center Clinical Research Office (UK MCC CRO)LexingtonKentucky40536-
JHU Oncology Central Kit ServicesBaltimoreMaryland21205-
Johns Hopkins HospitalBaltimoreMaryland21287-
Oncology Investigational Drug Service (IDS)BaltimoreMaryland21287-
Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsBaltimoreMaryland21287-
MidAmerica Cancer Care - American Oncology PartnersKansas CityMissouri64132-
Premier ImagingKansas CityMissouri64114-
St. Joseph Medical CenterKansas CityMissouri64114-
Nebraska MedicineOmahaNebraska68105-
Nebraska Medicine - Village PointeOmahaNebraska68118-
University of Nebraska Medical CenterOmahaNebraska68198-
Renown Health Medical OncologyRenoNevada89502-
Renown Office of Clinical ResearchRenoNevada89502-
Renown Regional Medical CenterRenoNevada89502-
Atlantic Health System / Morristown Medical CenterMorristownNew Jersey07960-
Jack & Sheryl Morris Cancer CenterNew BrunswickNew Jersey08901-
Rutgers Cancer InstituteNew BrunswickNew Jersey08901-
Rwj University Hospital SomersetSomervilleNew Jersey08876-
RWJ University Hospital Somerset, Steeplechase Cancer CenterSomervilleNew Jersey08876-
Atlantic Health System / Overlook Medical CenterSummitNew Jersey07901-
Icahn School of Medicine at Mount SinaiNew YorkNew York10029-
University of Rochester Medical CenterRochesterNew York14642-
UNC Hospitals, The University of North Carolina at Chapel HillChapel HillNorth Carolina27514-
University of North Carolina Hospitals at HillsboroughHillsboroughNorth Carolina27278-
OHSU Center for Health & Healing 1PortlandOregon97239-
Oregon Health and Science UniversityPortlandOregon97239-
OSHU Center for Health and Healing 2PortlandOregon97239-
Houston Methodist HospitalHoustonTexas77030-
Baylor Scott & White Vasicek Cancer Treatment CenterTempleTexas76508-
Fred Hutchinson Cancer CenterSeattleWashington98109-
University of Washington Medical CenterSeattleWashington98195-
Virginia Mason Medical CenterSeattleWashington98101-

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