About this trial
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.
Eligibility criteria
Qualifiers
Evidence of a personally signed and dated ICF indicating that the subject has been informed of all pertinent aspects of the study.
Age > 18.
ECOG performance status of 0-1.
Life expectancy of ≥ 3 months.
Disqualifiers
Plan to receive any other anti-tumor treatments during the treatment period of this study.
Subjects participated in a prior investigational study or received anticancer treatment, and have not recovered from side effects of such therapy.
Underwent major surgical operation within 4 weeks before the first dose of this IP.
Received treatments with strong CYP3A4, CYP2D6, P-gp, or BCRP inhibitors or inducers within < 5 half-lives of the drug before the first dose of the study.
Trial design
Treatments tested in this trial
- SHR-A1904