A Clinical Study of JS105 in Combination With Other Anti-tumor Therapies in Patients With Solid Tumors
NCT06208410 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 306
Last updated 2025-07-25
Summary
This study is an open-label, multicenter, Phase Ib/II clinical study to evaluate the safety, tolerability, pharmacokinetics, and preliminary efficacy of JS105 in combination with other anti-tumor therapies in patients with advanced solid tumors. Patients will be enrolled in two stages: a dose-escalation stage and a dose-expansion stage.
Conditions
Interventions
- DRUG
-
JS105
JS105 is administered once daily, orally
- DRUG
-
Fulvestrant injection
Fulvestrant intramuscularly,The first cycle was injected once in D1 and D15, and then once in each cycle D1, and 28 days was 1 cycle
- DRUG
-
Dalpiciclib Isetionate Tablets
Dalpiciclib Isetionate Tablets, QD, oral, taken continuously for 21 days, then stopped for 7 days, 28 days for a cycle
- DRUG
-
Toripalimab Injection
Toripalimab Injection,Intravenous infusion, once every 3 weeks, 21 days for 1 cycle
- DRUG
-
Paclitaxel for Injection (Albumin Bound)
Paclitaxel for Injection (Albumin Bound),Intravenous infusion, D1, 8, 15 infusion, every 28 days for a cycle
- DRUG
-
Fluzoparib Capsules
Fluzoparib Capsules is administered once daily, orally
- DRUG
-
Pyrotinib Maleate Tablets
Pyrotinib Maleate Tablets is administered once daily, orally
- DRUG
-
Capecitabine Tablets
Capecitabine Tablets is administered once daily, orally
Sponsors & Collaborators
-
Risen (Suzhou) Pharma Tech Co., Ltd.
lead INDUSTRY
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SEQUENTIAL
Eligibility
- Min Age
- 18 Years
- Max Age
- 75 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2024-01-11
- Primary Completion
- 2027-02-26
- Completion
- 2027-02-26
Countries
- China
Study Locations
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