Visugromab in Cachexia International Trial (VINCIT)

CatalYm

Status and phase: Enrolling; Phase 3; Phase 2

Conditions: Cancer-associated Cachexia

Treatments: Drug: Placebo; Drug: Visugromab (CTL-002)

Study type: Interventional

Funder types: Industry

Identifiers

NCT07112196

CTL-002-006

Details and patient eligibility

About

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.

Enrollment: 518 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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518 participants in 4 patient groups, including a placebo group

Visugromab low dose

Active Comparator group

Treatment:

Drug: Visugromab (CTL-002)

Drug: Visugromab (CTL-002)

Drug: Visugromab (CTL-002)

Visugromab medium dose

Active Comparator group

Treatment:

Drug: Visugromab (CTL-002)

Drug: Visugromab (CTL-002)

Drug: Visugromab (CTL-002)

Visugromab high dose

Active Comparator group

Treatment:

Drug: Visugromab (CTL-002)

Drug: Visugromab (CTL-002)

Drug: Visugromab (CTL-002)

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo