Key inclusion criteria: adults (18-75 years) with ECOG 0-1, recurrent/metastatic NPC, prior PD- (L)1 and chemotherapy failure, measurable lesions, and adequate organ function. Major exclusions: recent malignancies (exceptions apply), prior B7-H3/ADC/CAR-T therapy, inadequate washout, active infections, uncontrolled diseases, CNS metastases (unless stable), pregnancy, or conditions affecting compliance.

Secondary endpoints include ORR assessed by investigators, PFS (time to PD or death), DOR (duration of response), DCR (CR/PR/SD rate), and TTR (time to response), all evaluated within 36 months. Safety is assessed via adverse events (NCI CTCAE v5.0), PK parameters (AUC, Cmax, Ctrough, CL, Vd, t½), ADA incidence, and B7H3 expression correlation with efficacy.

Eligible patients (18-75 years, ECOG 0-1) must have confirmed relapsed SCLC progressing after platinum therapy, measurable lesions (RECIST 1.1), and adequate organ function. Key exclusions: recent malignancies (exceptions for cured cancers), prior B7-H3/ADC/CAR-T therapy, CNS metastases (unless stable), uncontrolled infections/conditions, active HBV/HCV, unresolved treatment toxicity, pregnancy, or factors compromising study compliance.

Secondary endpoints include investigator-assessed PFS (time to progression/death), ORR (CR/PR rate), DOR (duration of response), TTR (time to initial response), and DCR (CR/PR/SD rate). Safety assessment covers adverse events (NCI CTCAE v5.0), PK parameters (AUC, Cmax, Ctrough, CL, Vd, t½), ADA incidence, and tumor B7H3 expression correlation with efficacy, all evaluated over 36 months.

Exclusion criteria include prior B7H3-targeted therapy, concurrent interventional studies, topoisomerase I inhibitor/ADC treatment, insufficient washout periods, major surgery/transplants, prolonged glucocorticoid use (>28 days), recent live vaccines, pathological fracture risks, CNS metastases, uncontrolled urinary/cardiovascular/pulmonary conditions, Gilbert's syndrome, significant effusions, recent GI perforation/fistula or active ulcers, severe infections, HIV/HBV/HCV co-infections, other malignancies affecting survival, unresolved prior toxicity, or hypersensitivity to drug components.

The study evaluates YL201's efficacy in mCRPC patients through primary endpoints: Objective Response Rate (ORR) by RECIST1.1/PCWG3, radiographic Progression-Free Survival (rPFS), and recommended dose determination. Secondary endpoints include Disease Control Rate (DCR), Duration of Response (DoR), Time to Response (TTR), and PSA-related metrics along with safety, pharmacokinetics, and biomarker analysis, all assessed over approximately 36 months.

Inclusion criteria require signed informed consent, age ≥18 years, confirmed prostate adenocarcinoma with mCRPC diagnosis per specified criteria (castrate testosterone <50 ng/dL, PSA or imaging progression), prior novel hormone therapy, ≤2 chemotherapy lines, BRCA1/2-mutated patients with prior PARP inhibitor exposure if applicable, measurable metastatic lesions, and tumor tissue for B7H3 IHC testing. Additional requirements: ECOG PS 0-1, adequate organ function (Hb≥90g/L, ANC≥1.5×10⁹/L, PLT≥100×10⁹/L, liver/kidney thresholds), effective contraception, and ≥6-month life expectancy. Patients must comply with protocol procedures.

Inclusion criteria: Signed ICF, age &ge;18, ECOG PS 0-1, adequate organ function, effective contraception, and life expectancy &ge;3 months. Part 1 requires evaluable lesions (RECIST 1.1); Part 2 mandates measurable lesions and tumor samples for analysis. Exclusion criteria: Prior topoisomerase I inhibitor/ADC intolerance, concurrent interventional trials, recent anticancer therapies/surgeries, uncontrolled infections, active HBV/HCV/HIV, unresolved toxicity (NCI CTCAE >Grade 1), hypersensitivity to mAbs, breastfeeding/pregnancy, or conditions impairing compliance. Part 2 excludes multiple malignancies within 3 years (exceptions: cured non-melanoma skin/in situ cancers).

The study focuses on evaluating dose-limiting toxicities (DLTs) in Part 1 (Cycle 1, 21 days) and adverse events (AEs) in Part 2, assessing type, frequency, severity, and relationship to YL201 over ~36 months. Primary efficacy measures include PSA response rate (≥50% reduction) in prostate cancer patients and objective response rate (ORR, per RECIST 1.1) in non-prostate solid tumors.

Part 1 assesses AEs and pharmacokinetics (AUC, Cmax, Ctrough, CL, Vd, t1/2) alongside immunogenicity (anti-YL201 antibodies). Efficacy metrics for prostate cancer include PSA-PFS (PCWG3), rPFS (RECIST 1.1/PCWG3), and failure-free survival (FFS). For other solid tumors, ORR, disease control rate (DCR), duration of response (DoR), time to response (TTR), PFS, and overall survival (OS) are evaluated, all over ~36 months.

Inclusion criteria: Patients aged 18-75 with confirmed NSCLC, SCLC, NPC, ESCC, mCRPC, HNSCC, sarcoma, PDAC, HCC, or BTC, measurable lesions per RECIST 1.1, ECOG PS 0-1, acceptable contraception compliance, and life expectancy &ge;3 months. Exclusion: Prior B7H3 or topoisomerase 1 inhibitor treatment, concurrent clinical trials, recent major surgery, uncontrolled infections (HIV, HBV, HCV), active brain/spinal metastasis, immunosuppressive drug use, third-space effusions, unresolved toxicity, pregnancy, or conditions impairing protocol compliance.

This study evaluates adverse events (AEs) by type, frequency, severity, timing, seriousness, and relationship to treatment over 36 months. It assesses objective response rate (ORR) using RECIST 1.1 for solid tumors, defined as the proportion of patients achieving complete (CR) or partial response (PR). For prostate cancer patients, it measures PSA response rate, defined as ≥50% decrease from baseline.

The study characterizes pharmacokinetic (PK) parameters including AUC, Cmax, Ctrough, CL, Vd, and t1/2, and assesses anti-YL201 antibody incidence over 36 months. Secondary endpoints include disease control rate (DCR), duration of response (DoR), time to response (TTR), progression-free survival (PFS), overall survival (OS), and prostate cancer-specific measures like rPFS, time to PSA progression (TTPP), PSA duration of response (PDoR), and best PSA response.

Eligible patients must have advanced solid tumors (e.g., NPC, SCLC, NSCLC), measurable lesions (RECIST 1.1), ECOG PS 0-1, adequate organ function, and life expectancy &ge;3 months, while adhering to contraception requirements. Exclusions include prior B7H3/topoisomerase 1 inhibitor/anti-PD- (L)1 therapies, unresolved treatment toxicity, recent major surgery, uncontrolled infections (HIV/HBV/HCV), active autoimmune/systemic diseases, third-space effusions, brain/spinal metastases, or pregnancy/breastfeeding.

This study evaluates adverse events (AEs) in advanced solid tumors treated with YL201 combined with serplulimab, with or without platinum-based chemotherapy, over 36 months. Key objectives include determining the maximum tolerated dose (MTD), recommended expansion dose (RED), and recommended Phase 2 dose (RP2D), as well as assessing efficacy via objective response rate (ORR).

The pharmacokinetics (PK) of YL201 combination therapy will be evaluated, including parameters such as AUC, Cmax, Ctrough, CL, Vd, and t1/2. Additionally, efficacy measures including depth of response (DpR), disease control rate (DCR), duration of response (DoR), time to response (TTR), progression-free survival (PFS), and overall survival (OS) will be assessed per RECIST 1.1. Immunogenicity (anti-YL201 antibodies) and tumor biomarker expression (B7H3, PD-L1) will also be analyzed.