Actively Recruiting
A Phase 1b2 Study Evaluating Safety and Effectiveness of SHR-A2102 Combined With Other Anti-Cancer Drugs in Adults With Advanced Urothelial Carcinoma
Led by Shanghai Hengrui Pharmaceutical Co., Ltd. · Updated on 2024-11-18
90
Participants Needed
1
Research Sites
N/A
Total Duration
AI-Summary
What this Trial Is About
Researchers are evaluating the safety, tolerability, and effectiveness of SHR-A2102 combined with other anti-cancer agents in patients with advanced urothelial carcinoma. This study aims to find a suitable dose of SHR-A2102 for this advanced cancer type and includes participants who have either failed or are intolerant to standard treatments or have not received systemic antitumor therapy for their condition. Participants will receive SHR-A2102 together with Adebrelimab injection and SHR-8068 injection as experimental treatments. The study is conducted in phases, including Phase Ib to determine the recommended dose and Phase II to assess the treatments anti-tumor response. Treatment effects and safety will be monitored for up to approximately five years. During the study, participants will undergo tumor tissue sampling, disease measurement using RECIST criteria, and regular assessments for adverse events and treatment responses. Researchers will track outcomes like overall response rate, disease control rate, duration of response, progression-free survival, and overall survival. Safety monitoring includes evaluating immune-related side effects and pharmacokinetic measures of the drugs. Participation may last several years to gather long-term data on treatment effects and tolerability.
CONDITIONS
Brief Title
A Trial of SHR-A2102 With Antitumor Therapy in Advanced Urothelial Carcinoma
Research Team
C
Chun Yang
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