The study (dose escalation/expansion) is being conducted to assess the safety and tolerability of SHR-A1904 in subjects with advanced solid tumors, and to determine maximum tolerated dose (MTD) and/or recommended phase II dose (RP2D), to assess preliminary efficacy of SHR-A1904, pharmacokinetic (PK) profile and immunogenicity of SHR-A1904 in subjects with advanced solid tumors.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
83
Single Arm :It is a dose-escalation and dose-expansion study of SHR-A1904 in subjects with advanced solid tumors
Dose-limiting toxicity (DLT)
DLT is defined during the first cycle of the study treatment and assessed as certainly or at least possibly related to SHR-A1904 treatment.
Time frame: The first cycle of administration, up to 21 days.
Maximum tolerated dose (MTD)
MTD is defined as the dose with the estimated toxicity probability which is the closest to the target toxicity probability.
Time frame: The first cycle of administration, up to 21 days.
Recommended Phase 2 Dose (RP2D)
RP2D is the dose selected for further study based on the phase I study results.
Time frame: The first cycle of administration, up to 21 days.
Adverse events (AEs) and serious adverse events (SAEs)
Time frame: From the signing of informed consent form to the end of safety follow-up period (90 days after the last dose).
Objective response rate (ORR)
The proportion of efficacy evaluable subjects with the best overall response (BOR) of CR or PR as per RECIST 1.1 criteria.
Time frame: Evaluated until the end of study, approximately 12 months after the first dose of study drug of the last subject, currently estimated March 2026.
Duration of response (DoR)
DoR is defined as the time from first documented tumor response (CR/PR) until PD/death.
Time frame: Evaluated until the end of study, approximately 12 months after the first dose of study drug of the last subject.
Clinical benefit rate (CBR)
CBR is defined as the percentage of subjects who have achieved complete response (CR), partial response (PR) and/or stable disease (SD) lasting over 24 weeks (CR+PR+SD≥24 weeks).
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Mount Sinai Comprehensive Cancer Center
Miami Beach, Florida, United States
ACTIVE_NOT_RECRUITINGComprehensive Hematology Oncology
St. Petersburg, Florida, United States
TERMINATEDLSU Health Sciences Center
New Orleans, Louisiana, United States
ACTIVE_NOT_RECRUITINGUniversity Hospitals Cleveland Medical Center
Cleveland, Ohio, United States
TERMINATEDRhode Island Hospital
Providence, Rhode Island, United States
TERMINATEDPrisma Health
Greenville, South Carolina, United States
ACTIVE_NOT_RECRUITINGThe University of Texas MD Anderson Cancer Center
Houston, Texas, United States
ACTIVE_NOT_RECRUITINGCentral Coast Local Health District
Gosford, New South Wales, Australia
COMPLETEDSydney South West Private Hospital
Liverpool, New South Wales, Australia
COMPLETEDScientia Clinical Research Ltd
Randwick, New South Wales, Australia
COMPLETED...and 18 more locations
Time frame: Evaluated until the end of study, approximately 12 months after the first dose of study drug of the last subject.
Progression-free survival (PFS)
PFS is defined as the time from the first dose until PD/death.
Time frame: Evaluated until the end of study, approximately 12 months after the first dose of study drug of the last subject.
Overall survival (OS)
OS is defined as the time from first dose of study drug until death from any cause.
Time frame: Until the end of study, approximately 12 months after the first dose of study drug of the last subject.
Time to maximum concentration (Tmax)
Time frame: Up to 30 days after the last dose.
Maximum concentration (Cmax)
Time frame: Up to 30 days after the last dose.