Neoadjuvant Immunotherapy Combined With the Anti-GDF-15 Antibody Visugromab to Treat Muscle Invasive Bladder Cancer

Phase 2

Recruiting

• Conditions: Bladder Cancer; Adult Solid Tumor

• Registration Number: NCT06059547
• Lead Sponsor: CatalYm GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-8-23
• Last Update Posted: 2 September 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

Main Inclusion Criteria:<br><br> - Signed and dated informed consent, and able to comply with the study procedures and<br> any locally required authorization.<br><br> - Male or female aged = 18 years.<br><br> - Histopathologically confirmed urothelial carcinoma.<br><br> - Clinical Stage T2-T4aN0M0 MIBC.<br><br> - Ineligible for cisplatin therapy per modified Galsky criteria or refuses<br> cisplatin-based chemotherapy.<br><br> - Eligible for radical Cystectomy.<br><br> - Pretreatment tumor material from transurethral resection of the bladder tumor<br> (TURBT) must be available.<br><br> - Eastern Cooperative Oncology Group (ECOG) performance status 0-1.<br><br> - Adequate organ function (bone marrow, hepatic, renal function and coagulation).<br><br>Main Exclusion Criteria:<br><br> - Pregnant or breastfeeding.<br><br> - Received prior radiotherapy on the bladder tumor.<br><br> - Received a partial cystectomy.<br><br> - Any prior systemic anti-cancer therapy including investigational agents and<br> immunotherapy.<br><br> - Pre-existing arrhythmia, uncontrolled angina pectoris, uncontrolled heart failure<br> (NYHA) Grade IV, any myocardial infarction/coronary event, CNS-ischemic event and<br> any thromboembolic event at any time < 6 months prior to Screening or presence of<br> uncontrolled heart failure NYHA Grade III or higher.<br><br> - Left ventricular ejection fraction (LVEF) < 50% measured by echocardiogram or MUGA.<br><br> - QTcF = 470 ms regardless of sex.<br><br> - Any active autoimmune requiring systemic immunosuppressive treatments.<br><br> - Any history of non-infectious pneumonitis < 6 months prior to Screening.<br><br> - Any active inflammatory bowel disease such as Crohn's disease or ulcerative colitis<br> which are generally excluded or active autoimmunthyroiditis present < 6 months prior<br> to Screening.<br><br> - History of CNS disease such as stroke, seizure, encephalitis, or multiple sclerosis<br> (< 6 months prior to Screening).

Exclusion Criteria

Not provided

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Pathologic complete response rate;Radiologic response rate according RECIST

Secondary Outcome Measures

Name	Time	Method
Adverse Events;Treatment related delay of surgery;Cmax following the first dose of Visugromab (CTL-002);AUC following the first dose of Visugromab (CTL-002);Half-life of Visugromab (CTL-002);GDF-15 serum levels;Evaluation of tumor stage downgrading from baseline to Radical Cystectomy/Re-TURBT;Evaluation of EFS (Event-free Survival);OS (Overall Survival);Evaluation of TTR (Time to Relapse);isugromab-induced anti-drug antibodies (ADA) development.