RecruitingPhase 1NCT06832982

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


Sponsor

Shanghai Pushi Medical Science Co. Ltd

Enrollment

66 participants

Start Date

Feb 24, 2025

Study Type

INTERVENTIONAL

Conditions

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


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying Chemotherapy, a drug called FS-8002 injection, and others for people with advanced solid tumors. The study is currently recruiting participants at 10 locations. People eligible for this study include aged 18 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGFS-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_PRODUCTToripalimab 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_PRODUCTChemotherapy

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

View Full Details on ClinicalTrials.gov

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NCT06832982


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