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

Risen (Suzhou) Pharma Tech Co., Ltd.

Neoplasms

All Conditions

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Gland and Hormone Related Diseases

Rare Diseases

Adenocarcinoma

Ovarian Neoplasms

Carcinoma, Ovarian Epithelial

Cystadenocarcinoma, Serous

Carcinoma

Fallopian Tube Neoplasms

Cystadenocarcinoma

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Endocrine Gland Neoplasms

Ovarian Diseases

Adnexal Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Genital Neoplasms, Female

Urogenital Neoplasms

Endocrine System Diseases

Gonadal Disorders

Fallopian Tube Diseases

Neoplasms, Cystic, Mucinous, and Serous

Ovarian Cancer

Ovarian Epithelial Cancer

Fallopian Tube Cancer

Adenocarcinoma of the Appendix

Pharmaceutical Solutions

Bevacizumab

Angiogenesis Inhibitors

Antineoplastic Agents, Immunological

Growth Inhibitors

Fluzoparib capsule: oral administration, 3 capsules/dose (150 mg/ dose), twice a day, in the morning and evening, before/after meals can be taken orally, it is recommended to take orally within 0.5h after breakfast and dinner, continuous administration. Every 3 weeks is a treatment cycle.

Bevacizumab injection: intravenous, 15 mg/kg, every 3 weeks for a treatment cycle until disease progression or intolerable toxicity, up to a total of 15 months.

Chunyan Lan

Chunyan Lan, MD&PhD

This is an open-label, multi-center Phase II study of fluzoparib combined with bevacizumab for maintenance therapy after first-line platinum-containing chemotherapy in patients with BRCA wild-type advanced ovarian cancer. The primary objective is to evaluate median progression free survival of fluzoparib plus bevacizumab.

First-line Maintenance Treatment With Fluzoparib Plus Bevacizumab in Advanced BRCA Wild Type Ovarian Cancer

An Open, Multicenter, Exploratory Clinical Study of Fluzoparib in Combination With Bevacizumab for Maintenance Therapy After First-line Platinum-containing Chemotherapy in BRCA Wild-type Advanced Ovarian Cancer

Open collection of homologous recombination deficiency status (HRD) status was performed to assess the impact of HRD status on the efficacy of fluazoparib in combination with bevacizumab.

Time from the date of first study treatment administration to the date of first documented tumor progression or death due to any cause, whichever occurs first.

Time from the date of first study treatment administration to the date of death due to any cause.

ORR is the proportion of patients with best response of complete response (CR) and partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.

TFST is defined as the time from the first study administration to the earliest of the date of anti-cancer therapy start date following study treatment discontinuation, or death.

TSST is defined as the time from the first study administration to the earliest of the date of second subsequent anti-cancer therapy start date following study treatment discontinuation, or death.

Time to progression by RECIST v. 1.1 or CA-125 or death is defined as the time from the first study administration to the date of RECIST or CA-125 progression or death by any cause, whichever occurs first.

Incidence, nature, and severity of adverse events graded according to the NCI CTCAE v5.0.

Determination of changes in PROs with EQ-5D-5L

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
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.
First-line Maintenance Treatment With Fluzoparib Plus Bevacizumab in Advanced BRCA Wild Type Ovarian Cancer	NCT06063070	Ovarian Cancer High Grade Sero... High Grade Endo... Primary Periton... Fallopian-tube ...	Fluzoparib Caps... Bevacizumab	18 Years -	Sun Yat-sen University
First-line Maintenance Treatment With Fluzoparib Plus Bevacizumab in Advanced BRCA Wild Type Ovarian Cancer	NCT06063070	Ovarian Cancer High Grade Sero... High Grade Endo... Primary Periton... Fallopian-tube ...	Fluzoparib Caps... Bevacizumab	18 Years -	Sun Yat-sen University
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.

Spots Global Cancer Trial Database for fluzoparib capsules