Eligible patients (≥18 years, ECOG 0-1, life expectancy ≥3 months) must have advanced/metastatic solid tumors failing standard therapy with measurable lesions. Exclusions include recent antitumor treatments (within 4 weeks), active CNS metastases, uncontrolled infections (HBV/HCV/HIV), significant comorbidities, or unresolved toxicities (>Grade 1).

Eligible patients (≥18 years, ECOG 0-1, life expectancy ≥3 months) must have advanced/metastatic solid tumors failing standard therapy with measurable lesions. Exclusions include recent antitumor treatments (within 4 weeks), active CNS metastases, uncontrolled infections (HBV/HCV/HIV), significant comorbidities, or unresolved toxicities (>Grade 1).

Eligible participants are ≥18 years with locally advanced/recurrent metastatic breast cancer (HR+/HER2- or triple-negative), prior ADC exposure, and measurable disease (RECIST 1.1). Required organ function: HB ≥90 g/L, ANC ≥1.5×10⁹/L, ALT/AST ≤3×ULN (≤5×ULN with liver mets), LVEF ≥50%. Exclusions: uncontrolled CNS metastases, active HBV/HCV/HIV, major surgery/immunotherapy within 3 weeks, third-space effusions, or pregnancy. Prior endocrine therapy (including CDK4/6 inhibitors) requires ≥14-day washout.

Efficacy measures include progression-free survival (PFS; time to progression/death), clinical benefit rate (CBR; CR+PR+SD ≥24 weeks), and duration of response (DOR; sustained until progression/death)-all monitored for 36 months alongside treatment-related toxicity (CTCAE v5.0). Overall survival (OS) is tracked for 5 years, with censoring for surviving participants.

Eligible participants are female ≥18 years with untreated triple-negative breast cancer (TNBC) confirmed histologically, measurable lesions (RECIST 1.1), and ECOG 0-1. Key exclusions: prior anti-cancer therapy (chemotherapy/immunotherapy), active HBV/HCV, autoimmune/cardiovascular diseases, concurrent malignancies, or pregnancy. Organ function requirements: adequate bone marrow/hepatic reserves. Surgical recovery must be complete if applicable.

Eligible participants are 18-75 years, with advanced/metastatic pancreatic cancer (RECIST v1.1 measurable lesions) after standard treatment failure and ECOG 0-1. Exclusions: active CNS metastases, untreated HBV/HCV/HIV, recent major surgery, severe cardiovascular/thromboembolic events, or uncontrolled infections/autoimmune diseases. Key requirements: adequate organ function, negative pregnancy test, and contraception use.

Eligible patients are HR+/HER2- advanced breast cancer patients (ER/PR >10%+, HER2 non-amplified) with prior CDK4/6 inhibitor exposure, measurable lesions (RECIST 1.1), and adequate organ function (ANC ≥1.5x10⁹/L, platelets ≥75x10⁹/L, ALT/AST ≤3×ULN, Cr ≤1×ULN). Exclusions: uncontrolled CNS metastases, recent major surgery/chemotherapy (within 3 weeks), active cardiac disease, pregnancy, or other malignancies (past 5 years). Fertile patients must use contraception.

Eligible patients are 18-70 years with locally advanced/metastatic esophageal squamous cell carcinoma (RECIST 1.1 measurable lesions), ECOG 0-1, and adequate organ function. Exclusions: uncontrolled CNS metastases, active hepatitis B/C, recent major surgery/radiotherapy (within 4 weeks), gastrointestinal perforation/fistula (≤6 months), or prior topoisomerase I inhibitor ADCs. Fertile subjects must use contraception. Other exclusions: severe cardiovascular disease, thrombosis (≤3 months), unresolved toxicity (>Grade 1), or live vaccines (≤28 days).

The recommended Phase II dose (RP2D) will be determined based on safety, PK, and efficacy data during Phase IB (~1 year). Adverse events (AEs; NCI-CTCAE v5.0) and dose-limiting toxicities (DLTs) are monitored from Day 1 to 90 days post-last dose, while ORR (RECIST 1.1) is assessed every 6 weeks (≤48 weeks) and every 9 weeks thereafter, up to 18 months post-enrollment.

Eligible patients have recurrent/metastatic gynecological malignancies (RECIST 1.1 measurable), ECOG 0-1, and adequate organ function. Exclusions: active brain metastases, prior topoisomerase I inhibitor ADCs, major surgery within 28 days, active HBV/HCV/HIV, pulmonary tuberculosis (≤1 year), or SHR-A2102 hypersensitivity. Fertile females must use effective contraception for ≥7 months post-treatment.

Secondary efficacy measures include duration of response (DoR), disease control rate (DCR), time to response (TTR), and progression-free survival (PFS), all assessed via RECIST 1.1 at the same imaging intervals. Overall survival (OS) will be tracked every 60 days for up to 36 months, alongside 12-month survival rate. Safety will monitor AEs (NCI-CTCAE v5.0), while pharmacokinetic (PK) traits (plasma concentrations of SHR-A2102/metabolites) and immunogenicity (ADA/Nab levels) will be analyzed over 24 months.

Eligible subjects aged 18-70 must consent, provide tumor tissue, have measurable NSCLC (squamous), ECOG 0-1, ≥12-week life expectancy, and adequate organ function. Exclusions include active brain metastases, other malignancies (except certain cured cases), uncontrolled effusions/pain, recent anticancer treatments/radiotherapy/surgery, unresolved toxicities (>CTCAE1), immunosuppressive/autoimmune conditions, severe infections/CVD, hepatitis B/C, TB, bleeding risks, immunodeficiency, pregnancy, mental illness, or other investigator-judged risks.

The RP2D will be determined based on safety, PK, and efficacy data from Phase IB over approximately 1 year. AE incidence and severity (including DLTs) will be assessed per NCI-CTCAE v5.0 from Day 1 to 90 days post-last dose. ORR will be evaluated every 6 weeks for 48 weeks, then every 9 weeks for up to 18 months post-enrollment, using RECIST1.1 criteria.

Eligible patients (≥18 years, ECOG 0-1, life expectancy ≥12 weeks) must have locally advanced/metastatic solid tumors (failed standard therapy for Phase IB, untreated for Phase II) with measurable lesions. Key exclusions include active CNS metastases, prior topoisomerase I inhibitor ADC/PD-1/PD-L1 therapy (Phase II), recent antitumor treatment (within 4 weeks), unresolved toxicities (>Grade 1), active infections (HBV/HCV/TB), autoimmune diseases, or uncontrolled comorbidities. Pregnancy, recent live vaccines, major surgery (within 28 days), or severe allergies to study drugs also preclude participation.

Eligible patients (&ge;18 years, ECOG 0-1) must have histologically confirmed advanced urothelial carcinoma (treatment-experienced for Phase Ib, treatment-naive for Phase II) with measurable lesions. Key exclusions include active CNS metastases, prior TOPO1-ADC treatment, recent anticancer therapy (<4 weeks), unresolved toxicities (>Grade 1), uncontrolled autoimmune diseases, or significant cardiac/pulmonary complications.

Eligible participants must be aged 18-80 with ECOG 0-1, confirmed advanced/metastatic urothelial carcinoma post-platinum/PD- (L)1 therapy, and measurable lesions per RECIST v1.1. Exclusions involve recent anti-tumor treatments, prior topoisomerase I ADC exposure, uncontrolled CNS metastases, active infections, significant comorbidities, or pregnancy. Organ function and contraception compliance are required.