Visugromab (CTL-002)
Sponsors
CatalYm GmbH
Conditions
ADVANCED-STAGEAdult Solid TumorBladder CancerCancer-associated CachexiaMetastatic non-squamous non-small cell lung cancerMuscle invasive bladder cancer set to undergo radical cystectomy who cannot receive or
refuse to receive cisplatin-based chemotherapyRELAPSED/REFRACTORY SOLID TUMORSSolid Tumor, Adult
Phase 1
First-in-Human Study of the GDF-15 Neutralizing Antibody Visugromab (CTL-002) in Patients With Advanced Cancer (GDFATHER)
Active, not recruitingNCT04725474
Start: 2020-12-09End: 2030-04-30Updated: 2026-08-19
A Phase 1/2, first-in-human, two-part, open-label clinical trial of intravenous administration of CTL-002 given as monotherapy and/or in combination with an anti-PD-1 checkpoint inhibitor in subjects with advanced-stage, relapsed/refractory solid tumors.
Active, not recruitingCTIS2024-512575-12-00
Start: 2020-11-25Target: 169Updated: 2025-11-17
Phase 2
Neoadjuvant Immunotherapy Combined With the Anti-GDF-15 Antibody Visugromab to Treat Muscle Invasive Bladder Cancer
CompletedNCT06059547
Start: 2023-09-06End: 2026-06-05Updated: 2026-08-19
A multi-center Phase 2 study of neoadjuvant immunotherapy in combination with the anti-GDF-15 antibody visugromab (CTL-002) for the treatment of muscle invasive bladder cancer
Active, not recruitingCTIS2024-513957-55-00
Start: 2023-07-21Target: 31Updated: 2025-07-02
A Phase 2, Randomized, Blinded, Placebo-Controlled Trial Investigating the Efficacy and Safety of Visugromab versus Placebo, in Combination with Pembrolizumab, Pemetrexed, and Carboplatin, in First-Line Treatment of Participants with Metastatic Non-Squamous Non-Small Cell Lung Cancer (GDFATHER-NSCLC-01)
RecruitingCTIS2024-516792-32-01
Start: 2025-07-18Target: 82Updated: 2025-06-16
Visugromab in Cachexia International Trial
RecruitingNCT07112196
Start: 2026-04-16End: 2030-12-01Target: 518Updated: 2026-08-31
A Phase 2, Randomized, Blinded, Placebo-Controlled Trial Investigating the Efficacy and Safety of Visugromab plus Nivolumab with or without Docetaxel versus Docetaxel Monotherapy in Second-Line Treatment of Participants with Metastatic Non-Squamous Non-Small Cell Lung Cancer (GDFATHER-NSCLC-02)
RecruitingCTIS2024-516794-70-00
Start: 2025-11-03Target: 95Updated: 2025-11-07
A Phase 2b, Randomized, Blinded Trial Investigating the Efficacy and Safety of Visugromab in combination with Nivolumab and Lenvatinib compared to Double Placebo and Lenvatinib in Participants with Unresectable or Metastatic Hepatocellular Carcinoma and Compensated Liver Function (Child-Pugh A) after Failure of First-Line Treatment that Included an Anti-PD-(L)1 Compound (GDFATHER-HCC-01)
Not yet recruitingCTIS2025-520675-86-00
Target: 59Updated: 2026-01-09
Adaptive, Phase 2/3, Randomized, Double-Blind Trial Investigating the Efficacy and Safety of Visugromab versus Placebo in Patients with Cancer-associated Cachexia
Not yet recruitingCTIS2025-523533-25-00
Target: 44Updated: 2026-02-13