NCT06208410

A Clinical Study of JS105 in Combination With Other Anti-tumor Therapies in Patients With Solid Tumors

A Clinical Study of JS105 in Combination With Other Anti-tumor Therapies in Patients With Advanced Solid Tumors

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 306 (estimated)
• Sponsor: Risen (Suzhou) Pharma Tech Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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

• Advanced Solid Tumors

Interventions

Type	Name	Description
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

Timeline

• Start date: 2024-01-11
• Primary completion: 2027-02-26
• Completion: 2027-02-26
• First posted: 2024-01-17
• Last updated: 2025-07-25

Locations

1 site across 1 country: China