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Phase 1 Study to Assess Safety and Effectiveness of SPH7485 Tablets in Adults with Advanced Solid Tumors
Led by Shanghai Pharmaceuticals Holding Co., Ltd · Updated on 2025-08-17
170
Participants Needed
6
Research Sites
N/A
Total Duration
AI-Summary
What this Trial Is About
Researchers are studying SPH7485 tablets in patients with advanced solid tumors to assess how well the tablets work and how safe they are. This phase 1 clinical trial focuses on finding the right dose and understanding the drugs effects on patients with this condition. The study is sponsored by Shanghai Pharmaceuticals Holding Co., Ltd and aims to gather important early data on SPH7485. Participants will take SPH7485 tablets orally once daily, with doses ranging from 50 to 400 mg for 21 days per treatment cycle. The study includes dose-escalation and dose-expansion phases to evaluate safety, tolerability, and pharmacokinetics. The trial will monitor dose-limiting toxicities and determine the maximum tolerated dose over about 24 days. During the study, participants will have regular assessments for adverse events, laboratory tests, and evaluations of tumor response lasting up to two years. Researchers will track objective response rate, disease control rate, progression-free survival, and pharmacokinetic parameters like Tmax and Cmax. Participants must follow all study procedures and attend scheduled visits to ensure thorough monitoring and data collection throughout the trial.
CONDITIONS
Brief Title
A Clinical Study of SPH7485 Tablets in the Treatment of Advanced Solid Tumors.
Research Team
X
Xiaohua Wu
J
Jian Zhang
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