ARTEMIS-003: A Phase 2, Open-label, Multi-center Study to Evaluate Efficacy, Safety, and Pharmacokinetics, of Intravenous Administration of HS-20093 in Patients With Metastasis Castration Resistant Prostate Cancer and Advanced Solid Tumors Who Have Progressed Following at Least One Prior Therapy
HS-20093 is a fully humanized IgG1 antibody-drug conjugate (ADC) which specifically binds to B7-H3, a target wildly expressed on solid tumor cells. The objectives of this study are to investigate the anti-tumor activity, safety and pharmacokinetics of HS-20093 in Chinese patients with metastasis Castration Resistant Prostate Cancer. This is a phase 2, open-label, multi-center study to evaluate the efficacy, safety, tolerability and pharmacokinetic (PK) of HS-20093 as a monotherapy in subjects with metastasis castration resistant prostate cancers (mCRPC) and other solid tumors.
• Subjects eligible for inclusion in this study must meet all of the following criteria:
‣ Men or women greater than or equal to 18 years.
⁃ Locally advanced or metastatic solid tumors confirmed by histology or cytology, for which standard treatment is invalid, unavailable or intolerable.
⁃ At least one measurable lesion in accordance with RECIST 1.1.
⁃ Agree to provide fresh archival tumor tissue.
⁃ Eastern Cooperative Oncology Group (ECOG) Performance Status of 0\
⁃ Estimated life expectancy ≥ 12 weeks.
⁃ Men or women should be using adequate contraceptive measures throughout the study.
⁃ Female subjects must not be pregnant at screening or have evidence of non-childbearing potential.
⁃ Signed and dated Informed Consent Form.