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Purpose

A study of how well and safely a new drug called visugromab works in people with certain kinds of cancer (including lung and bowel cancer) and unintended weight loss known as cachexia. The main questions it aims to answer are: - Does visugromab help participants put weight back on and have a better appetite? - Does visugromab help participants move more and better? - What medical problems do participants have when taking visugromab? Researchers will compare visugromab to a placebo (a look-alike substance that contains no drug). Participants will visit the hospital or clinic once every 4 weeks to receive visugromab or placebo via a drip into a vein and to undergo checkups and tests.

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Weight loss - Advanced cancer

Exclusion Criteria

  • Participation in another interventional clinical trial, receipt of any investigational therapy or use of any investigational device within 4 weeks prior to screening and between screening and the first dose of investigational product

Study Design

Phase
Phase 2/Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Active Comparator
Visugromab low dose
  • Drug: Visugromab (CTL-002)
    Low dose
Active Comparator
Visugromab medium dose
  • Drug: Visugromab (CTL-002)
    Medium dose
Active Comparator
Visugromab high dose
  • Drug: Visugromab (CTL-002)
    High dose
Placebo Comparator
Placebo
  • Drug: Placebo
    IV infusion

Recruiting Locations

Eastern Connecticut Hematology & Oncology
Norwich, Connecticut 06360

Clermont Oncology Center
Clermont, Florida 34711

Mid Florida Hematology and Oncology Centers
Orange City, Florida 32763

Astera Cancer Care
East Brunswick, New Jersey 08816

Cleveland Clinic Avon Hospital
Avon, Ohio 44011

Cleveland Clinic (Main Campus)
Cleveland, Ohio 44195

Cleveland Clinic Fairview Hospital
Fairview, Ohio 44111

Cleveland Clinic Hillcrest Hospital
Mayfield Heights, Ohio 44124

More Details

Status
Recruiting
Sponsor
CatalYm GmbH

Study Contact

Trial Director
49 8920006640
regulatory-006@catalym.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.