FS-8002 injection
DrugQ3W or until the patient develops PD, intolerable toxicity, death, loss of follow-up, voluntary withdrawal, or the end of the study, whichever occurs first
NCT Number: NCT06832982
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
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Phase 1
Beijing Cancer Hospital, Beijing, Beijing Municipality, China
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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
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
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
Time frame: 1.5years
the maximum tolerated dose(MTD)
Time frame: 1.5years
the phase II recommended dose(RP2D)
Time frame: 1 years
incidence and serverity of DLT
Time frame: 2years
incidence and serverity of adverse events(AE)
Time frame: 2years
incidence and serverity of serious adverse events(SAE)
Time frame: 1.5years
the pharmacokinetic parameters of FS-8002: peak concentration (Cmax)
Time frame: 1.5years
the pharmacokinetic parameters of FS-8002: peak time (Tmax)
Time frame: 1.5years
the pharmacokinetic parameters of FS-8002: area under the plasma concentration-time curve (AUC)
Time frame: 1.5years
the pharmacokinetic parameters of FS-8002: Terminal half-life
Time frame: 1.5years
the pharmacokinetic parameters of FS-8002: elimination rate constant
Time frame: 1.5years
Anti-drug antibody
Time frame: 1.5years
According to the efficacy evaluation criteria for solid tumors version 1.1 (RECIST V1.1): to evaluate objective response rate (ORR)
Time frame: 1.5years
According to the efficacy evaluation criteria for solid tumors version 1.1 (RECIST V1.1): to evaluate disease control rate (DCR)
Time frame: 1.5years
According to the efficacy evaluation criteria for solid tumors version 1.1 (RECIST V1.1): to evaluate duration of response (DOR)
Time frame: 1.5years
According to the efficacy evaluation criteria for solid tumors version 1.1 (RECIST V1.1): to evaluate progression-free survival (PFS)
Time frame: 1.5years
According to the efficacy evaluation criteria for solid tumors version 1.1 (RECIST V1.1): to evaluate overall survival (OS)
Time frame: 1.5years
Cytokines: interferon gamma (IFN-γ), interleukin (IL) -2, IL-10, IL-12, and IL-15.
Contact information is provided by the study sponsor or research team.
Shanghai Pushi Medical Science Co. Ltd
Industry
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
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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