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RECRUITING
NCT06832982
PHASE1

Evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacokinetics, and Preliminary Efficacy of FS-8002

Sponsor: Shanghai Pushi Medical Science Co. Ltd

View on ClinicalTrials.gov

Summary

this is a single-arm, open phase I clinical trial evaluating the safety, tolerability, pharmacokinetics, pharmacokinetics, and preliminary efficacy of FS-8002 and combination therapy in patients with advanced solid tumors

Official title: A Single-arm, Open Phase I Clinical Trial Evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacokinetics, and Preliminary Efficacy of FS-8002 in Patients With Advanced Solid Tumors

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

66

Start Date

2025-02-24

Completion Date

2028-02-19

Last Updated

2026-04-09

Healthy Volunteers

No

Interventions

DRUG

FS-8002 injection

Q3W or until the patient develops PD, intolerable toxicity, death, loss of follow-up, voluntary withdrawal, or the end of the study, whichever occurs first

COMBINATION_PRODUCT

Toripalimab Injection

Q3W or until the patient develops PD, intolerable toxicity, death, loss of follow-up, voluntary withdrawal, or the end of the study, whichever occurs first

COMBINATION_PRODUCT

Chemotherapy

Administrated per the chemotherapy chosed by the investigator until the patient develops PD, intolerable toxicity, death, loss of follow-up, voluntary withdrawal, or the end of the study, whichever occurs first

Locations (10)

Beijing Cancer Hospital

Beijing, Beijing Municipality, China

Fujian Cancer hospital

Fujian, Fuzhou, China

The First Affiliated Hospital of Zhejiang Medical University

Zhejiang, Hangzhou, China

Harbin Medical University Cancer Hospital

Heilongjiang, Harbin, China

Cancer Hospital of Shandong First Medical University(Shandong Cancer Institute,Shandong Cancer Hospital)

Shandong, Jinan, China

Meizhou People's Hospital

Guangdong, Meizhou, China

The First Affiliated Hospital of China Medical University

Shenyang, Shenyang, China

Hebei General Hospital

Hebei, Shijiazhuang, China

Union Hospital, Tongji Medical College

Hubei, Wuhan, China

Hubei Cancer Hospital

Hubei, Wuhan, China