A Study of HS-20124 in Patients with Advanced Solid Tumors
Trial Parameters
Brief Summary
HS-20124 is a novel DAR-8 antibody-drug conjugate （ADC） targeting CDH6. In preclinical studies, it inhibited tumor cell growth expressing CDH6 in vitro and in vivo. The first-in-human trial is conducted to assess the maximum tolerated dose (MTD) and dose limiting toxicity (DLT), to evaluate the pharmacokinetics, safety and preliminary anti-tumor activity of HS-20124 in Patients With Advanced Solid Tumors.
Eligibility Criteria
Inclusion Criteria: 1. At least age of 18 years at screening; 2. Histologically or cytologically confirmed, locally advanced or metastatic solid tumors for which standard treatment either does not exist or has proven ineffective or unavailable or intolerable 3. At least one extra-cranial measurable lesion according to RECIST 1 4. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0\~1 5. Life expectancy \>= 12 weeks 6. Men or women should be using adequate contraceptive measures throughout the study; 7. Females subjects must not be pregnant at screening or have evidence of non-childbearing potential 8. Signed and dated Informed Consent Form Exclusion Criteria: 1.Treatment with any of the following: 1. Previous or current treatment with CDH6 targeted therapy 2. Any cytotoxic chemotherapy and small molecule targeted anticancer drugs within 21 days or five half-livesprior to the first scheduled dose of HS-20124 3. Prior treatment with a monoclonal antibody or investigational