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

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.

Timeline

Start

2020-12-09

Primary completion

2028-04-30

Completion

2030-04-30

Publications

• Melero I, de Miguel M, Cabanas EG, de Velasco G, Joerger M, Martin-Liberal J, Reig M, Konig D, Trojan J, Goebeler ME, Schuler M, Alonso G, Dummer R, Rodriguez-Ruiz ME, Yarza R, Pretelli G, Esteban-Villarubia J, Koster KL, Viltro PS, Sanduzzi-Zamparelli M, Laubli H, Koch C, Sayehli C, Gromke T, Racca F, Ramelyte E, Galle PR, Necchi A, Reck M, Trajanoski Z, Hackl H, Gogolla F, Billing J, Sattmann T, Wischhusen J, Schuberth-Wagner C, Akdemir J, Lichtenegger FS, Auckenthaler A, Fox M, Klar K, Fettes P, Liebig M, Amin A, Sachdeva S, Hermann F, Leo E. Long-term follow-up of a phase 1/2 trial of anti-GDF-15 antibody visugromab plus anti-PD-1 antibody nivolumab in anti-PD-1/-L1 relapsed/refractory solid tumors. J Hematol Oncol. 2026 Jul 9. doi: 10.1186/s13045-026-01818-2. Online ahead of print.

Drugs

Indications