Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of BL-M05D1 in Subjects With Solid Tumors
Trial Parameters
Brief Summary
The objective of this study is to evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of BL-M05D1 in Subjects with Advanced or Metastatic Solid Tumors.
Eligibility Criteria
Inclusion Criteria: 1. Signed the informed consent form voluntarily and agreed to follow the program requirements 2. Age: ≥18 years 3. Has a life expectancy of ≥3 months 4. Has documented locally advanced or metastatic solid tumor(s) that are known to potentially express CLDN18.2 as defined below that have recurred or progressed on at least 1 line of prior systemic therapy (including adjuvant/neoadjuvant), have no other standard of care options, and have no available curative options, including: 1. Gastric or gastroesophageal junction (G/GEJ) adenocarcinoma (AC): Subjects with CLDN18.2, human epidermal growth factor receptor 2 (HER2), PD-L1 and/or microsatellite instability high (MSI-H)/ mismatch repair deficiency (dMMR) positive tumors must have received targeted treatment in their prior lines of therapy. 2. Pancreatic ductal AC (PDAC): Subjects may enter screening prior to completing the first line of standard therapy. 3. Esophageal AC (EAC): Subjects with HER2, PD-L1 and/or MSI-H/dM