Visugromab for cancer-related wasting and unintended weight loss
Adaptive, Phase 2/3, Randomized, Double-Blind Trial Investigating the Efficacy and Safety of Visugromab Versus Placebo in Patients With Cancer-associated Cachexia
This trial will test whether visugromab helps people with advanced cancer and unintentional weight loss (cachexia) gain weight, have a better appetite, and improve mobility compared with a placebo.
Quick facts
| Phase | Phase2; Phase3 |
|---|---|
| Study type | Interventional |
| Enrollment | 518 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | CatalYm GmbH Industry-sponsored |
| Drugs / interventions | visugromab |
| Locations | 7 sites (Orange City, Florida and 6 other locations) |
| Trial ID | NCT07112196 on ClinicalTrials.gov |
What this trial studies
This phase 2/3 interventional trial compares the investigational drug visugromab to a placebo in people with cancer-associated cachexia. Participants are assigned to receive visugromab or placebo by intravenous infusion once every four weeks and return for regular checkups and tests. Key outcomes include changes in body weight, appetite, physical activity and function, and monitoring of side effects and safety. The study is conducted at multiple international centers and follows participants over repeated monthly visits.
Who should consider this trial
Good fit: Adults with advanced cancer who have unintentional weight loss consistent with cachexia (including patients with lung or bowel cancers) and who meet the study's medical criteria are the intended participants.
Not a fit: Patients without cancer-associated unintentional weight loss, those currently enrolled in another interventional investigational trial within the prohibited window, or those unable to receive IV infusions are unlikely to benefit from participating.
Why it matters
Potential benefit: If successful, visugromab could help people with cancer-associated cachexia regain weight, improve appetite, and increase physical function.
How similar studies have performed: Treatments for cancer cachexia to date have had mixed results, so visugromab represents a newer approach that is still being tested in larger trials.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Orange City, Florida and 6 other locations
- Mid Florida Hematology and Oncology Centers — Orange City, Florida, United States (Recruiting)
- Specialized Hospital for Active Treatment in Oncology — Haskovo, Bulgaria (Recruiting)
- Léon Bérard Center (Centre Léon Bérard) — Lyon, France (Recruiting)
- Oslo University Hospital — Oslo, Norway (Recruiting)
- University Hospital of A Coruña (Hospital Universitario de A Coruña) — A Coruña, Spain (Recruiting)
- Cantonal Hospital St. Gallen (Kantonsspital St. Gallen) — Sankt Gallen, Switzerland (Recruiting)
- University Hospital of Zurich (Universitätsspital Zürich) — Zurich, Switzerland (Recruiting)
Study contacts
- Study coordinator: Trial Director
- Email: regulatory-006@catalym.com
- Phone: 49 8920006640
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.