NCT06832982

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

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

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 66 (estimated)
• Sponsor: Shanghai Pushi Medical Science Co. Ltd · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Conditions

• Advanced Solid Tumors

Interventions

Type	Name	Description
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

Timeline

• Start date: 2025-02-24
• Primary completion: 2028-02-19
• Completion: 2028-02-19
• First posted: 2025-02-18
• Last updated: 2026-04-09

Locations

10 sites across 1 country: China