Actively Recruiting
Study of JS105 Combined With Various Anti-Tumor Treatments for Adults With Advanced Solid Tumors
Led by Risen (Suzhou) Pharma Tech Co., Ltd. · Updated on 2025-07-25
306
Participants Needed
1
Research Sites
N/A
Total Duration
AI-Summary
What this Trial Is About
Researchers are evaluating JS105 combined with other anti-tumor therapies in patients with advanced solid tumors in this open-label, multicenter Phase IbII clinical trial. The study aims to assess the safety, tolerability, pharmacokinetics, and early effectiveness of JS105 in combination with various treatments across two stages dose escalation and dose expansion. This research focuses on patients with different types of advanced solid tumors including breast, endometrial, cervical, ovarian, and gynecologic cancers. The study includes multiple treatment groups where JS105 is given orally daily along with other anti-tumor drugs such as Fulvestrant intramuscular, Dalpiciclib oral, Toripalimab intravenous infusion, Paclitaxel intravenous infusion, Fluzoparib oral, Pyrotinib oral, and Capecitabine oral. Each combination varies by study arm and involves specific dosing schedules like cycles of 28 days or infusions every 3 weeks. Participants receive these treatments during the dose-escalation and dose-expansion phases. Participants will be closely monitored with assessments including dose-limiting toxicity, maximum tolerated dose, and adverse events over up to two years. The study tracks objective response rates, disease control, survival, and detailed pharmacokinetic parameters of JS105 and combination drugs at set intervals. Safety evaluations and detailed follow-up visits help researchers understand how the treatments affect patients over time and inform future therapy use.
CONDITIONS
Brief Title
A Clinical Study of JS105 in Combination With Other Anti-tumor Therapies in Patients With Solid Tumors
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