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Visugromab (CTL-002)

DRUG9 trials

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

Phase 2

Neoadjuvant Immunotherapy Combined With the Anti-GDF-15 Antibody Visugromab to Treat Muscle Invasive Bladder Cancer
CompletedNCT06059547
CatalYm GmbHAdult Solid Tumor, Bladder Cancer
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
CatalYm GmbHMuscle invasive bladder cancer set to undergo radical cystectomy who cannot receive or refuse to receive cisplatin-based chemotherapy
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
CatalYm GmbHMetastatic non-squamous non-small cell lung cancer
Start: 2025-07-18Target: 82Updated: 2025-06-16
Visugromab in Cachexia International Trial
RecruitingNCT07112196
CatalYm GmbHCancer-associated Cachexia
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
CatalYm GmbHMetastatic non-squamous non-small cell lung cancer
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
CatalYm GmbHUnresectable or Metastatic Hepatocellular Carcinoma and Compensated Liver Function (Child-Pugh A)
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
CatalYm GmbHCancer-associated Cachexia
Target: 44Updated: 2026-02-13

Related Papers

Regular and Young Investigator Award Abstracts2023-10-311 citations