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
Jiangsu HengRui Medicine Co., Ltd.
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.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Evidence of a personally signed and dated ICF indicating that the subject has been informed of all pertinent aspects of the study. 2. Age \>18. 3. ECOG performance status of 0-1. 4. Life expectancy of ≥3 months. 5. Subjects with pathologically diagnosed advanced relapsed or refractory solid tumors, either gastric and gastroesophageal junction (GEJ) cancer, or pancreatic cancer, who are intolerable to SoC, have progressed through all available treatment options, or for whom there is no efficacious treatment available. Subjects must have pathological classification (e.g.,…
Interventions
- DrugSHR-A1904
Single Arm :It is a dose-escalation and dose-expansion study of SHR-A1904 in subjects with advanced solid tumors
Locations (28)
- Mount Sinai Comprehensive Cancer CenterMiami Beach, Florida
- Comprehensive Hematology OncologySt. Petersburg, Florida
- LSU Health Sciences CenterNew Orleans, Louisiana
- University Hospitals Cleveland Medical CenterCleveland, Ohio
- Rhode Island HospitalProvidence, Rhode Island
- Prisma HealthGreenville, South Carolina