Eligible participants (18-75 for Ia, ≥18 for Ib) have advanced/metastatic solid tumors (e.g., gastrointestinal) with ECOG 0-1, adequate organ function (ANC ≥1.5×10⁹/L, platelets ≥100×10⁹/L, etc.), and measurable lesions (Ib: RECIST 1.1). Exclusions: recent antitumor therapy (4 weeks/5 half-lives), prior TROP2/camptothecin ADCs, severe cardiac/autoimmune disease, uncontrolled infections, CNS metastases (unless stable >1 month), or pregnancy. HIV/HBV/HCV active infections and QTc prolongation (>450/470 msec) also exclude.

Eligible participants (age 18-75 for Phase Ia, &ge;18 for Phase Ib) have advanced/metastatic solid tumors, ECOG 0-1, adequate organ function (ANC &ge;1.5&times;10⁹/L, platelets &ge;90&times;10⁹/L), and measurable lesions (Phase Ib). Key exclusions include recent anti-cancer therapy (within 4 weeks/5 half-lives), prior TROP2-ADC treatment, severe cardiac disease (LVEF <50%, QTc >450/470 msec), active CNS metastases (unless stable >1 month), uncontrolled infections (HBV/HCV/HIV), and autoimmune disorders requiring systemic treatment.

Safety assessments include monitoring treatment-emergent adverse events (TEAEs) for 24 months. PK parameters (Cmax, Tmax, T1/2, AUC0-t, CL, Ctrough) are measured within 21 days post-dose. Immunogenicity (ADA/Nab) analysis and efficacy evaluation (ORR/DCR per RECIST 1.1, DOR, PFS) continue for approximately 24 months, with response criteria requiring ≥30% tumor reduction for PR or disappearance of lesions for CR.

Eligible patients (&ge;18 years) have advanced solid tumors (primarily NSCLC) with ECOG 0-1, measurable lesions (RECIST 1.1), and adequate organ function (ANC &ge;1.5&times;10⁹/L, platelets &ge;100&times;10⁹/L, LVEF &ge;50%). Key exclusions include recent anticancer therapy (within 4 weeks/5 half-lives), prior Trop2-ADC treatment, uncontrolled cardiovascular disease (QTc >450/470 msec), active CNS metastases, HIV/HBV/HCV infections, and severe comorbidities. Tumor tissue submission is required unless waived by investigators.

The Phase Ib study establishes the RP2D for BL-M02D1 based on integrated safety, tolerability, efficacy, PK and PD data from dose escalation. The primary Phase II endpoint is ORR (≥30% tumor reduction per RECIST 1.1) assessed over 24 months. Pharmacokinetic analysis investigates Cmax, Tmax, Ctrough, T1/2, AUC0-T and CL during the first 21 days post-dose.

Safety monitoring includes TEAE assessment for 24 months, with efficacy evaluations encompassing DCR (CR+PR+SD), DOR (time to progression/death) and PFS. Immunogenic response is tracked through ADA frequency. Primary endpoints differ between phases: ORR serves as the key efficacy measure in both Phase Ib and II cohorts, while PFS represents a secondary endpoint in Phase II studies following initial RP2D determination.