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FS-8002

Phase 1

Advanced Solid Tumors | Small molecule | Oncology |Co-Diagnostics, Inc.|Last Updated: Apr 9, 2026

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
CONTROLLEDBiomarker
Total Trials1
Total Enrollment66
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT06832982Evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacokinetics, and Preliminary Efficacy of FS-8002PHASE1 RECRUITING 66Feb 24, 2025Feb 19, 2028Apr 9, 202610 China
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Study Endpoints
Primary Endpoints
MTD
1.5years

the maximum tolerated dose(MTD)

RP2D
1.5years

the phase II recommended dose(RP2D)

DLT
1 years

incidence and serverity of DLT

AE
2years

incidence and serverity of adverse events(AE)

SAE
2years

incidence and serverity of serious adverse events(SAE)

Secondary Endpoints
peak concentration (Cmax)
1.5years
peak time (Tmax)
1.5years
area under the plasma concentration-time curve (AUC)
1.5years
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSEQUENTIAL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Single dose escalationEXPERIMENTAL42patients for dose escalation ,total 6 dose group
Combination therapy-FS8002 and Toripalimab InjectionEXPERIMENTALToripalimab Injection and FS8002
Combination therapy-FS8002 and Toripalimab Injection and ChemotherapyEXPERIMENTALToripalimab Injection and FS8002 and Chemotherapy
Interventions
NameTypeDescription
FS-8002 injectionDRUGQ3W or until the patient develops PD, intolerable toxicity, death, loss of follow-up, voluntary withdrawal, or the end of the study, whichever occurs first
Toripalimab InjectionCOMBINATION_PRODUCTQ3W or until the patient develops PD, intolerable toxicity, death, loss of follow-up, voluntary withdrawal, or the end of the study, whichever occurs first
ChemotherapyCOMBINATION_PRODUCTAdministrated 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
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites10

Inclusion Criteria: 1. Patients with advanced solid tumors confirmed by histology or cytology who have failed or become intolerant to previous standard treatments, or who do not have a standard treatment regimen.GBM patients must be primary GBM and first recurrence after adjuvant radiochemotherapy;...

Countries:China
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