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Clinical Trials List

Protocol NumberC3651003
NCT Number(ClinicalTrials.gov Identfier)NCT05546476
Completed

2023-01-01 - 2025-05-31

Phase II

Recruiting6

ICD-10R64

Cachexia

ICD-9799.4

Cachexia

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)

  • Sponsor

  • Trial scale

    Multi-Regional Multi-Center

  • Update

    2026/02/01

Investigators and Locations

Principal Investigator Li-Yuan Bai Division of Hematology & Oncology
China Medical University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 陳彥勳 無
Chi Mei Hospital, Liouying

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Hung-Chih Hsu Division of Hematology & Oncology
Linkou Chang Gung Medical Foundation

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Li-Tzong Chen Division of Hematology & Oncology
Kaohsiung Medical Univeristy Chung-Ho Memorial Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 陳新炫醫師 無
Koo Foundation Sun Yat-Sen Cancer Center

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Chia-Jui Yen Division of General Internal Medicine
National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Condition/Disease

Non-small Cell Lung Cancer 、Pancreatic Cancer、 Colorectal Cancer、 Loss of Appetite 、Fatigue、 Cachexia

Objectives

Study the efficacy, safety and tolerability of PONSEGROMAB in patients with cancer, cachexia, and elevated growth differentiation factor 15 (GDF-15) concentrations.

Test Drug

Ponsegromab
Placebo

Active Ingredient

Ponsegromab
Placebo

Dosage Form

Subcutaneous injection
Subcutaneous injection

Dosage

100 mg/mL
Placebo

Endpoints

Changes in body weight at week 12 compared with baseline.

Inclution Criteria

Key Inclusion Criteria:

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.

Exclusion Criteria

Key Exclusion Criteria:

Receiving tube feedings or parenteral nutrition at the time of Screening or Randomization.
Current active reversible causes of decreased food intake.
Cachexia caused by other reasons.
History of allergic or anaphylactic reaction to any therapeutic or diagnostic monoclonal antibody.
inadequate liver function
renal disease requiring dialysis

The Estimated Number of Participants

  • Taiwan

    18 participants

  • Global

    168 participants

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