AN OPEN-LABEL, SINGLE-ARM, MULTI-CENTER PHASE I/IIA CLINICAL STUDY TO EVALUATE THE SAFETY, TOLERABILITY, PHARMACOKINETICS, AND EFFICACY OF SHR-A1904 IN SUBJECTS WITH ADVANCED SOLID TUMORS
Summary
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.
Arms & interventions
- DrugSHR-A1904
Single Arm :It is a dose-escalation and dose-expansion study of SHR-A1904 in subjects with advanced solid tumors
Outcome measures
Primary
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).
Secondary
Objective response rate (ORR)
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)
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)
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)
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)
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.
Eligibility criteria
Study locations (7)
Mount Sinai Comprehensive Cancer Center
Miami Beach, Florida, 33140
Comprehensive Hematology Oncology
St. Petersburg, Florida, 33709
LSU Health Sciences Center
New Orleans, Louisiana, 70112
University Hospitals Cleveland Medical Center
Cleveland, Ohio, 44106
Rhode Island Hospital
Providence, Rhode Island, 02905
Prisma Health
Greenville, South Carolina, 29605
The University of Texas MD Anderson Cancer Center
Houston, Texas, 77030