Antineoplastic Agents

All Drugs and Chemicals

Capecitabine

Paclitaxel

Fulvestrant

Albumin-Bound Paclitaxel

Fluzoparib

Maleic acid

Tubulin Modulators

Antimitotic Agents

Antimetabolites

Antineoplastic Agents, Hormonal

Estrogens

Estrogen Antagonists

Estrogen Receptor Antagonists

Hormones

Hormone Antagonists

Enzyme Inhibitors

Poly(ADP-ribose) Polymerase Inhibitors

JS105 administered orally, Fulvestrant intramuscularly

JS105 administered orally, Dalpiciclib administered orally, Fulvestrant intramuscularly

JS105 administered orally, Toripalimab intravenous infusion

JS105 administered orally, Paclitaxel (Albumin Bound) intravenous infusion

JS105 administered orally, Fluzoparib administered orally

JS105 administered orally, Pyrotinib administered orally,Capecitabine administered orally

JS105 administered orally, Toripalimab intravenous infusion, Paclitaxel (Albumin Bound) intravenous infusion

JS105

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

Fulvestrant injection

Dalpiciclib Isetionate Tablets, QD, oral, taken continuously for 21 days, then stopped for 7 days, 28 days for a cycle

Dalpiciclib Isetionate Tablets

Toripalimab Injection,Intravenous infusion, once every 3 weeks, 21 days for 1 cycle

Toripalimab Injection

Paclitaxel for Injection (Albumin Bound),Intravenous infusion, D1, 8, 15 infusion, every 28 days for a cycle

Paclitaxel for Injection (Albumin Bound)

Fluzoparib Capsules is administered once daily, orally

Fluzoparib Capsules

Pyrotinib Maleate Tablets is administered once daily, orally

Pyrotinib Maleate Tablets

Capecitabine Tablets is administered once daily, orally

Capecitabine Tablets

Jing Ding

Min Yan

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.

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

The proportion of patients with PIK3CA mutations in tumor remission

Abnormal changes in clinical symptoms, vital signs, physical examination, laboratory tests, electrocardiograph and other examinations.

Objective Response Rate (ORR) as Assessed by Investigator according to RECIST v1.1

Duration of Objective Response (DOR) as Assessed by Investigator according to RECIST v1.1

Progression-Free Survival (PFS) as Determined by Investigator according to RECIST v1.1

Area under the curve of JS105,dalpiciclib and fluzoparib

Time to reach maximum concentration of JS105,dalpiciclib and fluzoparib

Maximum Plasma Concentration (Cmax) of JS105, dalpiciclib and fluzoparib

Apparent volume of distribution of JS105, dalpiciclib and fluzoparib

Clearance(CL) of JS105, dalpiciclib and fluzoparib

Half-life(T1/2) of JS105, dalpiciclib and fluzoparib

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
A Clinical Study of JS105 in Combination With Other Anti-tumor Therapies in Patients With Solid Tumors	NCT06208410	Advanced Solid ...	JS105 Fulvestrant inj... Dalpiciclib Ise... Toripalimab Inj... Paclitaxel for ... Fluzoparib Caps... Pyrotinib Malea... Capecitabine Ta...	18 Years - 75 Years	Risen (Suzhou) Pharma Tech Co., Ltd.
A Clinical Study of JS105 in Combination With Other Anti-tumor Therapies in Patients With Solid Tumors	NCT06208410	Advanced Solid ...	JS105 Fulvestrant inj... Dalpiciclib Ise... Toripalimab Inj... Paclitaxel for ... Fluzoparib Caps... Pyrotinib Malea... Capecitabine Ta...	18 Years - 75 Years	Risen (Suzhou) Pharma Tech Co., Ltd.

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