Eligible participants are adults (≥18) with progressing solid tumors after standard therapy, measurable disease per RECIST 1.1, ECOG 0-1, and adequate organ/cardiac function. Key exclusions include prior HER3/topoisomerase I inhibitor ADC therapy (with exceptions), significant cardiac/corneal/pulmonary conditions, active untreated CNS metastases, uncontrolled infections, QTc >470ms, and active hepatitis/HIV. Reproductive requirements mandate contraception for 4-7 months post-treatment.

Phase 1 evaluates safety parameters including dose-limiting toxicities (DLTs) during Cycle 1 and treatment-emergent adverse events (TEAEs)/serious adverse events (SAEs) over approximately 1 year, while determining Maximum Tolerated Dose (MTD) and Recommended Phase 2 Dose (RP2D) of DB-1310. Phase 2a continues monitoring TEAEs/SAEs while assessing efficacy through Objective Response Rate (ORR) per RECIST 1.1 over 1 year.

Pharmacokinetic assessments (AUC, Cmax, Tmax, T1/2) for DB-1310 components are conducted across both phases within 8 treatment cycles (21 days each). Efficacy evaluations include ORR, duration of response (DOR), disease control rate (DCR), progression-free survival (PFS) and overall survival (OS) per RECIST 1.1, with investigator-assessed tumor responses.

Eligible patients must be ≥18 years old, have adequate organ function, and meet disease-specific criteria (NSCLC: EGFR-mutant, prior 3rd-gen TKI; BC: HR+/HER2-, prior CDK4/6i + endocrine therapy). Key exclusions include prior HER3-targeted therapy, uncontrolled cardiovascular/ocular disease, active infections, severe toxicities, or unresolved organ dysfunction. Pregnancy, breastfeeding, or immunosuppressive conditions are also disqualifying.

YL202 is provided as the lyophilized powder, 200 mg/vial. YL202 will be given intravenously once every 3 weeks (Q3W) as a cycle. The initial dose of YL202 will be infused IV into each patient for 90 ±10 minutes. If there is no infusion-related reaction after the initial dose, the second and subsequent doses of YL202 will be infused IV into each patient for 60 ±10 minutes.

Eligible patients must be ≥18 years old, have adequate organ function, and meet disease-specific criteria (NSCLC: EGFR-mutant, prior 3rd-gen TKI; BC: HR+/HER2-, prior CDK4/6i + endocrine therapy). Key exclusions include prior HER3-targeted therapy, uncontrolled cardiovascular/ocular disease, active infections, severe toxicities, or unresolved organ dysfunction. Pregnancy, breastfeeding, or immunosuppressive conditions are also disqualifying.

YL202 is provided as the lyophilized powder, 200 mg/vial. YL202 will be given intravenously once every 3 weeks (Q3W) as a cycle. The initial dose of YL202 will be infused IV into each patient for 90 ±10 minutes. If there is no infusion-related reaction after the initial dose, the second and subsequent doses of YL202 will be infused IV into each patient for 60 ±10 minutes.

Eligible patients had advanced/metastatic HR-/HER2- or HR+/HER2-low breast cancer post-ADC failures, measurable lesions, adequate organ function, and life expectancy ≥3 months. Key exclusions included prior HER3 therapy, topoisomerase I inhibitor intolerance, active infections, uncontrolled comorbidities, recent major surgery/vaccines, CNS metastases, or other malignancies within 5 years.

Eligible patients (18-75 years) must have histologically confirmed advanced/metastatic solid tumors (e.g., NSCLC, BC, HNSCC), ≥1 measurable lesion, ECOG PS 0-1, adequate organ function, and contraception compliance. Exclusions involve prior HER3-targeted therapy, topoisomerase I inhibitor intolerance, recent major surgery/live vaccines, uncontrolled comorbidities (CNS metastases, cardiovascular/pulmonary/GI disorders, infections, HIV/HBV/HCV), other malignancies, or pregnancy/lactation.