Recruiting

Phase 2

Phase 3

PonsegromabA 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

Sponsor:

Pfizer

Code:

NCT06989437

Conditions

Cachexia

Metastatic Pancreatic Ductal Adenocarcinoma

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

ponsegromab

placebo

Study Details

Brief summary:

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.

Conditions

Cachexia

Metastatic Pancreatic Ductal Adenocarcinoma

Study ID

NCT06989437

Start date

Oct 3, 2025

Status verified date

Aug, 2026

Completion date

Dec 10, 2029

Anticipated

Primary completion date

Jan 17, 2028

Anticipated

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Key inclusion Criteria:

Signed Informed Consent Document
Documented active diagnosis of metastatic pancreatic ductal adenocarcinoma
Cachexia defined by Fearon criteria of weight loss
Completed 1 x 28-day cycle of first-line systemic nab-paclitaxel and gemcitabine chemotherapy or 2 x 14-day cycles of FOLFIRINOX chemotherapy and prior to receiving Cycle 2 chemotherapy
ECOG PS ≤1 with life expectancy of at least 4 months

Key Exclusion Criteria:

Current active reversible causes of decreased food intake
Cachexia caused by other reasons
Any prior or current clinical diagnosis of heart failure, irrespective of left ventricular ejection fraction or New York Heart Association classification
Left ventricular ejection fraction <50%
Receiving tube feedings or parenteral nutrition at the time of Screening or Randomization
History of allergic or anaphylactic reaction to any therapeutic or diagnostic monoclonal antibody
History of allergy or hypersensitivity to any of the chemotherapeutics or any of their excipients
Neuroendocrine (carcinoid, islet cell) or acinar pancreatic carcinoma, symptomatic brain metastasis, leptomeningeal disease or other active CNS metastases
Inadequate liver function
Renal disease requiring dialysis or eGFR <30 mL/min/1.73m2

Study Design

Enrollment

982 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

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

Interventions

ponsegromab

Double-Blind ponsegromab Treatment

placebo

Double-Blind placebo Treatment

Primary outcome measure

Percent change from baseline in body weight for ponsegromab compared to placebo [ Time Frame: Baseline, Week 12 ]
Change from baseline in Functional Assessment of Anorexia/Cachexia Therapy 5-item Anorexia Symptom Scale scores [ Time Frame: Baseline, Week 12 ]

Central Contacts and Locations

Central contacts

Pfizer CT.gov Call Center

1-800-718-1021 ClinicalTrials.gov_Inquiries@pfizer.com

Locations

The Kirklin Clinic of UAB Hospital

Recruiting

Birmingham, Alabama, United States, 35233

The University of Alabama at Birmingham

Recruiting

Birmingham, Alabama, United States, 35294

Mayo Clinic Hospital

Recruiting

Phoenix, Arizona, United States, 85054

Central Arkansas Radiation Therapy Institute, dba CARTI

Recruiting

Bryant, Arkansas, United States, 72022

Central Arkansas Radiation Therapy Institute, dba CARTI

Recruiting

Conway, Arkansas, United States, 72034

CARTI Cancer Center

Recruiting

Little Rock, Arkansas, United States, 72205

Central Arkansas Radiation Therapy Institute, dba CARTI

Recruiting

North Little Rock, Arkansas, United States, 72117

Central Arkansas Radiation Therapy Institute, dba CARTI

Recruiting

Pine Bluff, Arkansas, United States, 71603

UC San Diego Medical Center - Encinitas

Recruiting

Encinitas, California, United States, 92024

Chao Family Comprehensive Cancer Center and Ambulatory Care

Recruiting

Irvine, California, United States, 92612

UCI Health - Irvine

Recruiting

Irvine, California, United States, 92612

UC San Diego Koman Family Outpatient Pavilion

Recruiting

La Jolla, California, United States, 92037

UC San Diego Medical Center - La Jolla (Jacobs Medical Center / Thornton Pavilion)

Recruiting

La Jolla, California, United States, 92037

UC San Diego Moores Cancer Center

Recruiting

La Jolla, California, United States, 92037

UC San Diego Sulpizio Cardiovascular Center

Recruiting

La Jolla, California, United States, 92037

Cedars-Sinai Cancer at Cedars-Sinai Medical Center

Recruiting

Los Angeles, California, United States, 90048

UCLA Department of Medicine - Hematology/Oncology

Recruiting

Los Angeles, California, United States, 90095

UC Irvine Health

Recruiting

Orange, California, United States, 92868

UC San Diego Medical Center - Bankers Hill

Recruiting

San Diego, California, United States, 92101

UC San Diego McGrath Outpatient Pavilion - Hillcrest

Recruiting

San Diego, California, United States, 92103

UC San Diego Medical Center - Hillcrest

Recruiting

San Diego, California, United States, 92103

UC San Diego Medical Center - Rancho Bernardo

Recruiting

San Diego, California, United States, 92127

UCLA Hematology/Oncology - Santa Monica

Recruiting

Santa Monica, California, United States, 90404

Providence Medical Foundation

Recruiting

Santa Rosa, California, United States, 95403

UC San Diego Medical Center - Vista

Recruiting

Vista, California, United States, 92081

Georgetown University Medical Center - Department of Pharmacy, Oncology Pharmacy

Recruiting

Washington D.C., District of Columbia, United States, 20007

Georgetown University Medical Center

Recruiting

Washington D.C., District of Columbia, United States, 20007

Mayo Clinic Pharmacy

Recruiting

Jacksonville, Florida, United States, 32224

Mayo Clinic

Recruiting

Jacksonville, Florida, United States, 32224

University Cancer & Blood Center, LLC

Recruiting

Athens, Georgia, United States, 30607

Invision, LLC

Recruiting

Honolulu, Hawaii, United States, 96813

University of Hawaii Cancer Center

Recruiting

Honolulu, Hawaii, United States, 96813

Cardiology Associates, Inc

Recruiting

‘Aiea, Hawaii, United States, 96701

Cancer Care Specialists of Illinois

Recruiting

Decatur, Illinois, United States, 62526

Decatur Memorial Hospital

Recruiting

Decatur, Illinois, United States, 62526

Hope and Healing Clinical Research LLC

Recruiting

Hinsdale, Illinois, United States, 60521

Hope and Healing Clinical Research LLC New Lenox- Research Department

Recruiting

New Lenox, Illinois, United States, 60451

Cancer Care Specialists of Illinois - Cancer Care Center of O'Fallon

Recruiting

O'Fallon, Illinois, United States, 62269

United Imaging Consultants

Recruiting

Lenexa, Kansas, United States, 66215

MidAmerica Cancer Care- American Oncology Partners

Recruiting

Merriam, Kansas, United States, 66204

University of Kentucky Research Foundation

Recruiting

Lexington, Kentucky, United States, 40506

University of Kentucky Healthcare - Markey Cancer Center

Recruiting

Lexington, Kentucky, United States, 40536

University of Kentucky Medical Center

Recruiting

Lexington, Kentucky, United States, 40536

University of Kentucky, Markey Cancer Center Clinical Research Office (UK MCC CRO)

Recruiting

Lexington, Kentucky, United States, 40536

JHU Oncology Central Kit Services

Recruiting

Baltimore, Maryland, United States, 21205

Johns Hopkins Hospital

Recruiting

Baltimore, Maryland, United States, 21287

Oncology Investigational Drug Service (IDS)

Recruiting

Baltimore, Maryland, United States, 21287

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Recruiting

Baltimore, Maryland, United States, 21287

Mayo Clinic Cancer Center Outpatient Pharmacy

Recruiting

Rochester, Minnesota, United States, 55905

Mayo Clinic

Recruiting

Rochester, Minnesota, United States, 55905

Premier Imaging

Recruiting

Kansas City, Missouri, United States, 64114

St. Joseph Medical Center

Recruiting

Kansas City, Missouri, United States, 64114

MidAmerica Cancer Care - American Oncology Partners

Recruiting

Kansas City, Missouri, United States, 64132

Nebraska Medicine

Recruiting

Omaha, Nebraska, United States, 68105

Nebraska Medicine - Village Pointe

Recruiting

Omaha, Nebraska, United States, 68118

University of Nebraska Medical Center

Recruiting

Omaha, Nebraska, United States, 68198

Renown Health Medical Oncology

Recruiting

Reno, Nevada, United States, 89502

Renown Office of Clinical Research

Recruiting

Reno, Nevada, United States, 89502

Renown Regional Medical Center

Recruiting

Reno, Nevada, United States, 89502

Atlantic Health System / Morristown Medical Center

Recruiting

Morristown, New Jersey, United States, 07960

Jack & Sheryl Morris Cancer Center

Recruiting

New Brunswick, New Jersey, United States, 08901

Rutgers Cancer Institute

Recruiting

New Brunswick, New Jersey, United States, 08901

RWJ University Hospital Somerset, Steeplechase Cancer Center

Recruiting

Somerville, New Jersey, United States, 08876

Rwj University Hospital Somerset

Recruiting

Somerville, New Jersey, United States, 08876

Atlantic Health System / Overlook Medical Center

Recruiting

Summit, New Jersey, United States, 07901

Icahn School of Medicine at Mount Sinai

Recruiting

New York, New York, United States, 10029

University of Rochester Medical Center

Recruiting

Rochester, New York, United States, 14642

UNC Hospitals, The University of North Carolina at Chapel Hill

Recruiting

Chapel Hill, North Carolina, United States, 27514

University of North Carolina Hospitals at Hillsborough

Recruiting

Hillsborough, North Carolina, United States, 27278

OHSU Center for Health & Healing 1

Recruiting

Portland, Oregon, United States, 97239

Oregon Health and Science University

Recruiting

Portland, Oregon, United States, 97239

OSHU Center for Health and Healing 2

Recruiting

Portland, Oregon, United States, 97239

University of Texas Southwestern Medical Center - Simmons Cancer Center

Recruiting

Dallas, Texas, United States, 75235

University of Texas Southwestern Medical Center-William P. Clements Jr. University Hospital

Recruiting

Dallas, Texas, United States, 75235

University of Texas Southwestern Medical Center-Zale Lipshy University Hospital

Recruiting

Dallas, Texas, United States, 75390

University of Texas Southwestern Medical Center

Recruiting

Dallas, Texas, United States, 75390

Houston Methodist Hospital

Recruiting

Houston, Texas, United States, 77030

Baylor Scott & White Vasicek Cancer Treatment Center

Recruiting

Temple, Texas, United States, 76508

Virginia Mason Medical Center

Recruiting

Seattle, Washington, United States, 98101

Fred Hutchinson Cancer Center

Recruiting

Seattle, Washington, United States, 98109

University of Washington Medical Center

Recruiting

Seattle, Washington, United States, 98195

Froedtert Hospital and the Medical College of Wisconsin

Recruiting

Milwaukee, Wisconsin, United States, 53226

Arthur J.E. Child Comprehensive Cancer Centre

Recruiting

Calgary, Alberta, Canada, T2N 5G2

The Ottawa Hospital - General Campus

Recruiting

Ottawa, Ontario, Canada, K1H 8L6

Sunnybrook Research Institute

Recruiting

Toronto, Ontario, Canada, M4N 3M5

Unity Health Toronto, St. Michael's Hospital

Recruiting

Toronto, Ontario, Canada, M5B 1W8

Princess Margaret Cancer Centre - University Health Network

Recruiting

Toronto, Ontario, Canada, M5G 2M9

CIUSSS- saguenay-Lac-Saint-Jean

Recruiting

Chicoutimi, Quebec, Canada, G7H 5H6

Centre Intégré de Santé et de Services Sociaux de la Montérégie-Centre

Recruiting

Greenfield Park, Quebec, Canada, J4V 2H1

Jewish General Hospital

Recruiting

Montreal, Quebec, Canada, H3T 1E2

More Information

Sponsor

Pfizer

Last update posted

Aug 24, 2026

Last verified

Aug, 2026

Keywords

pancreatic cancer
metastatic cancer
cancer
anorexia
cachexia
weight loss
loss of appetite
fatigue

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Pfizer on 2026-08-24.