Inclusion criteria include: age ≥18, life expectancy ≥6 months, informed consent, measurable disease by RECIST v1.1, ECOG 0-1, and adequate organ function. Part B requires Tissue Factor (TF)-positive tumors via IHC. Exclusions involve: TF-negative tumors (Part B), unresolved toxicities (>Grade 1), active CNS metastases, recent anticancer therapy (≤21 days), bleeding/cardiac risks, uncontrolled infections, pregnancy, HIV/hepatitis, strong CYP3A4 modifiers use, or conditions deemed unsafe by investigators. Prior radiotherapy toxicities must resolve to Grade ≤1.

The primary endpoints for this study include determining the Maximum Tolerated Dose (MTD) (assessed within the first 21-day treatment cycle) as the highest dose where <33% of patients experience Dose-Limiting Toxicity (DLT), and establishing the Recommended Phase II Dose (RP2D) based on safety, efficacy, and PK data (evaluated over 24 months). Additional metrics are Objective Response Rate (ORR) (CR+PR rate by Independent Central Review) and Adverse Events (AEs) (recorded from informed consent until 45 days post-last dose), covering all trial-related side effects regardless of causality.

Key secondary outcomes encompass efficacy measures: Duration of Response (DoR) (time from initial response to progression/death), Disease Control Rate (DCR) (CR+PR+SD≥6 weeks), Progression-Free Survival (PFS) (time to progression/death), and Overall Survival (OS) (time to death from any cause), all tracked for up to 24 months. Pharmacokinetic parameters (Cmax, Tmax, AUClast) and Anti-Drug Antibody (ADA) incidence are evaluated from baseline to 30 days post-treatment.