Eligible participants must have HER2+ advanced solid tumors refractory to standard therapy, ≥1 measurable lesion (RECIST v1.1), ECOG PS 0-1, adequate organ function, and contraceptive use. Key exclusions: CNS metastases, active lung/autoimmune diseases, severe allergies, uncontrolled cardiac conditions, concurrent malignancies (5-year window), or bleeding disorders.

Eligible participants (age 18-75, ECOG PS 0-1) must have HER2-positive disease confirmed via tissue testing, ≥1 measurable lesion (RECIST v1.1), and adequate organ function, with stringent contraception requirements. Exclusions include active brain/CNS metastases, untreated interstitial lung disease, uncontrolled infections/cardiovascular conditions, prior therapies within 4 weeks, unresolved toxicities (>Grade 1), concurrent malignancies (5-year window), and severe allergies to SHR-4602 components.

Secondary endpoints include duration of response (DoR), progression-free survival (PFS), best overall response (BOR), disease control rate (DCR), incidence and severity of adverse events (AEs/SAEs) graded per CTCAE v5.0, and pharmacokinetic parameters (blood concentrations of conjugated/total antibodies and free toxin), all monitored over two years.

Eligible participants (ECOG PS 0-1, HER2+ advanced solid tumors, life expectancy ≥12 weeks) must have adequate organ function and provide consent. Key exclusions: active brain metastases, recent anticancer therapies (4 weeks), unresolved toxicities (Grade>1), uncontrolled infections, bleeding disorders, active hepatitis B/C, other malignancies (5-year window), or SHR-4602 hypersensitivity.

Additional exclusion criteria involve untreated hepatitis, recent live vaccines (28 days), known allergies to study drug components, uncontrolled mental illness, substance abuse, other malignancies within 5 years, active tuberculosis, or any condition deemed to compromise study integrity by investigators. Requirements include consent provision and commitment to contraception until 8 months post-treatment.

The primary endpoint is ORR by investigator assessment, defined as the percentage of participants achieving confirmed CR or PR per RECIST v1.1, evaluated over approximately 5 years. Secondary endpoints include DCR (CR+PR+SD), DoR (time from first response to PD/death), PFS (time from treatment start to PD/death), OS (time to death from any cause), and incidence of AEs.

Eligible participants aged 18-80 with ECOG 0-1 must have confirmed advanced/metastatic solid tumors after ≥1 line of prior therapy, measurable lesions per RECIST v1.1, expected survival ≥12 weeks, adequate organ function, and HER2 expression (Stage I). Key exclusions include active CNS metastases, recent anticancer therapy (within 4 weeks), unresolved toxicities > Grade 1, significant lung/cardiac diseases, active infections/autoimmune disorders, pregnancy/lactation, and prior severe immune-related AEs from checkpoint inhibitors.