Eligible patients (18-80 years, ECOG 0-1) must have advanced solid tumors (excluding sarcoma, with Nectin-4 testing in expansion cohorts), measurable disease (RECIST 1.1), and adequate organ function. Exclusions: recent anticancer therapies/surgeries (within 14-28 days), prior MMAE/nectin-4 ADCs, uncontrolled comorbidities (CNS metastases, diabetes, neuropathy ≥Grade 2), or CYP3A4/P-gp modifiers within 14 days. Contraception is mandatory during and for 6 months post-study

Eligible patients (18-80 years, ECOG 0-1) must have advanced solid tumors (excluding sarcoma, with Nectin-4 testing in expansion cohorts), measurable disease (RECIST 1.1), and adequate organ function. Exclusions: recent anticancer therapies/surgeries (within 14-28 days), prior MMAE/nectin-4 ADCs, uncontrolled comorbidities (CNS metastases, diabetes, neuropathy ≥Grade 2), or CYP3A4/P-gp modifiers within 14 days. Contraception is mandatory during and for 6 months post-study

Eligible patients (18-75 years) must have ECOG 0-1, measurable disease (RECIST v1.1), adequate organ function, and ≥12-week life expectancy. Key exclusions: Grade ≥2 treatment-related toxicities or peripheral neuropathy; active autoimmune diseases; recent anticancer therapies (chemotherapy/radiotherapy within 21 days or immunotherapy within 14 days); prior nectin-4 targeted ADC treatment; major surgery within 28 days; significant cardiac/cerebrovascular events within 6 months; or other active malignancies within 3 years. Contraception is required during and for 6 months post-treatment.

Secondary outcomes include duration of response (DoR), time to response (TTR), disease control rate (DCR), progression-free survival (PFS), and overall survival (OS) all assessed over 24 months. Pharmacokinetic analysis will measure Cmax, AUC, t1/2, and CL of TAb, ADC, and MMAE. Anti-drug antibody (ADA) incidence will be monitored throughout the study period.

Eligible patients must have ECOG 0-1, ≥12-week life expectancy, measurable disease (RECIST v1.1), and ≤2 prior systemic therapies (including platinum-based chemo ± bevacizumab). Exclusions: non-HPV-associated histologies, recent anticancer treatments (chemotherapy/radiation within 21 days; investigational drugs within 28 days), Grade ≥2 toxicity, uncontrolled comorbidities (HbA1c ≥8%, active infections, CNS metastases), major surgery within 28 days, or prior nectin-4/MMAE-based ADCs. Contraception is required during and for 6 months post-study.

Eligible patients (18-80 years, ECOG 0-1) must have advanced solid tumors (Phase Ia) or metastatic UC (Phase Ib), prior ICI/GC/GP therapy exposure, measurable disease (RECIST 1.1), adequate organ function, and provide tumor samples. Exclusions: recent anticancer therapies/surgeries (14-28 days), Grade ≥2 toxicity/neuropathy, MMAE-ADC treatment, uncontrolled comorbidities (CNS metastases, diabetes, cardiovascular disease), or strong CYP3A4/P-gp modifiers within 14 days. Contraception is mandatory during and 6 months post-study.

Eligible participants (18-80 years, ECOG 0-1) must have histologically confirmed locally advanced/metastatic urothelial cancer, prior standard therapy (or treatment-naïve), measurable lesions (RECIST 1.1), adequate organ function, and tumor tissue availability. Exclusions encompass recent anticancer treatments (within 21 days), prior MMAE-ADC/PD- (L)1 therapy, significant treatment-related toxicity (≥Grade 2), uncontrolled comorbidities (CNS metastases, infections, diabetes), major surgery (within 28 days), strong CYP3A4/P-gp modifiers (14 days), active corneal risks, or conditions posing significant safety concerns. Contraception is required during and for 6 months post-study.

The key efficacy assessments consist of Objective Response Rate (ORR), Duration of Response (DOR), Time to Response (TTR), Disease Control Rate (DCR), Progression-Free Survival (PFS), and Overall Survival (OS), all evaluated over a 24-month timeframe; additional PK parameters (9MW2821 concentration) and immunogenicity (ADA) data will be collected for up to 12 months.

Eligible subjects (18-75 years, ECOG 0-1) must have locally advanced/metastatic urothelial cancer (platinum/PD- (L)1-refractory), measurable disease (RECIST 1.1), and adequate organ function. Exclusions: recent anticancer therapies (21 days), prior nectin-4/MMAE-ADC treatment, major surgery (28 days), Grade ≥2 toxicity/neuropathy, uncontrolled comorbidities (CNS metastases, HbA1c ≥8%, cardiac/cerebrovascular disease within 6 months), strong CYP3A4 modifiers (14 days), active infections, or conditions posing safety risks. Contraception is mandatory during and post-study (6 months).

Eligible participants (≥18 years) must have high-risk NMIBC (non-muscle invasive, BCG/gemcitabine-refractory) post-TURBT (within 6 weeks), ECOG 0-1, and adequate organ function. Exclusions: prior muscle-invasive/metastatic disease, recent anticancer therapies (3 weeks), unresolved toxicity (>Grade 1), active infections, cardiovascular events (6 months), Nectin-4/MMAE-ADC exposure, or positive HBV/HCV/HIV serology. Contraception is mandatory during and for 180 days post-treatment.

Eligible participants (18-80 years, ECOG 0-1) must have untreated locally advanced/metastatic urothelial cancer (RECIST v1.1-measurable, cisplatin/carboplatin-suitable), adequate organ function, and accessible tumor tissue. Exclusions: prior malignancies (3 years), autoimmune/cardiovascular conditions (6 months), recent therapies (surgery/radiotherapy/CYP3A4 modulators), Grade ≥2 residual toxicity (excluding alopecia), active infections, Nectin-4/MMAE-ADC or checkpoint inhibitor exposure, uncontrolled CNS metastases, HBV/HCV/HIV coinfection, drug allergies, or high-risk ocular/neurological conditions. Contraception and protocol compliance are mandatory.

Eligible patients (18-80 years, ECOG 0-1) must have untreated, histologically confirmed inoperable locally advanced/metastatic urothelial carcinoma (>50% urothelial differentiation) with ≥1 measurable lesion (RECIST v1.1). Key exclusions: other malignancies (3 years), active autoimmune disease requiring immunosuppressants, recent major cardiovascular/thromboembolic events (6 months), prior PD-1/PD-L1/CTLA-4/Nectin-4/MMAE-ADC therapy, uncontrolled infections, untreated CNS metastases, positive HBV/HCV/HIV serology, or drug allergies. Contraception and protocol adherence are mandatory.

Secondary efficacy assessments include Overall Survival (OS), Progression-Free Survival (PFS), Duration of Response (DoR), Disease Control Rate (DCR), and ORR (investigator- and BICR-assessed). Safety monitoring covers treatment-emergent and -related adverse events (CTCAE v5.0), serious adverse events, and vital/lab abnormalities. Immunogenicity analysis measures ADA/NAb incidence, rates, and titers over 3 years.