Clinical Trial

First-in-Human Study of the GDF-15 Neutralizing Antibody Visugromab (CTL-002) in Patients With Advanced Cancer (GDFATHER)

Study acronym: GDFATHER
Active, Not Recruiting Phase 1/2
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Summary
The Phase 1 part (Part A) is a dose escalation study of IV visugromab (CTL-002, a monoclonal antibody neutralizing GDF-15) as monotherapy and in combination with an approved checkpoint inhibitor (CPI) in patients with advanced solid tumors. Enrolment into the Ph 1 part is completed. The Phase 2 parts (Part B) are cohort expansions with visugromab (CTL-002) in combination with a defined CPI at a fixed dose into seven different solid tumor indications.
Protocol Amendment History 6 amendments
This ClinicalTrials.gov record has been amended 6 times since 2021-01-25; most recent amendment 2026-01-09.
Status change: Recruiting → Active, Not Recruiting 2024-08-07
Trial Details
NCT Number NCT04725474
Lead Sponsor CatalYm GmbH
Conditions Solid Tumor, Adult
Enrollment 263 participants
Start Date 2020-12-09
Primary Completion 2028-04-30 (estimated)
Study Completion 2030-04-30 (estimated)
Updated on ClinicalTrials.gov 2026-01-12