Eligibility requires confirmed advanced/metastatic solid tumors, ECOG 0-1, life expectancy ≥12 weeks, and adequate organ function, excluding recent cancer therapy, unresolved toxicities (>Grade 1), major surgery, active infections, uncontrolled comorbidities (CNS, cardiovascular, hepatic, GI), HIV/hepatitis B/C, drug hypersensitivity, or pregnancy risk. Exclusions also cover conditions jeopardizing protocol compliance.

The study evaluates treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) graded by CTCAE v5.0, occurring from first dose until 30 days post-treatment. Key efficacy measures include Objective Response Rate (ORR) by Independent Central Review (ICR) using RECIST 1.1 criteria, with CR/PR definitions for tumor assessment, analyzed in the TNBC Target Population during phase 2 over 49 months.

Eligibility requires confirmed advanced/metastatic solid tumors, ECOG 0-1, life expectancy ≥12 weeks, and adequate organ function, excluding recent cancer therapy, unresolved toxicities (>Grade 1), major surgery, active infections, uncontrolled comorbidities (CNS, cardiovascular, hepatic, GI), HIV/hepatitis B/C, drug hypersensitivity, or pregnancy risk. Exclusions also cover conditions jeopardizing protocol compliance.

The study evaluates treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) graded by CTCAE v5.0, occurring from first dose until 30 days post-treatment. Key efficacy measures include Objective Response Rate (ORR) by Independent Central Review (ICR) using RECIST 1.1 criteria, with CR/PR definitions for tumor assessment, analyzed in the TNBC Target Population during phase 2 over 49 months.

The primary endpoint was progression-free survival (PFS) assessed by IRC and investigators per RECIST 1.1, measuring time from randomization to PD or death over 24 months. Key secondary endpoints included overall survival (OS), objective response rate (ORR), clinical benefit rate (CBR), and duration of response (DoR), all evaluated over 24 months using RECIST 1.1 criteria. Quality of life was assessed via NCC-BC-A scale, while safety covered AEs, SAEs (CTCAE 5.0), pharmacokinetic parameters (clearance, volume of distribution), and ADA incidence.

Eligible patients were adults (≥18 years) with HR+/HER2- breast cancer failing ≥1 line of chemotherapy, measurable lesions per RECIST 1.1, ECOG 0-1, and adequate organ function. Key exclusions included recent anti-cancer therapies (within 4 weeks), unresolved toxicities (>Grade 1), major surgery within 4 weeks, prior topoisomerase I/TROP2 inhibitors, untreated CNS metastases, active infections, uncontrolled comorbidities (cardiovascular, GI, HIV, hepatitis B/C), or hypersensitivity to irinotecan/excipients.

Key inclusion criteria include adults ≥18 years with histologically confirmed TNBC (metastatic or relapsed), no prior systemic therapy for advanced disease, PD-L1-negative or PD-L1-positive post-relapse, measurable lesions, ECOG 0-1, and adequate organ function. Exclusion criteria cover recent investigational drugs, prior topoisomerase I/TROP2 therapy, severe comorbidities (CNS metastases, cardiovascular disease, uncontrolled infections, gastrointestinal disorders), drug hypersensitivity, and pregnancy/lactation.

The primary endpoints include Progression-Free Survival (PFS) assessed by Blinded Independent Central Review (BICR) and Overall Survival (OS). PFS is defined as the time from randomization to disease progression per RECIST 1.1 or death, while OS measures time from randomization to any-cause death, with follow-up periods of approximately 28 and 41 months, respectively.

Secondary endpoints encompass investigator-assessed PFS, Objective Response Rate (ORR), Disease Control Rate (DCR), Duration of Response (DoR), and Time to Response (TTR) evaluated by both BICR and investigator. Additional assessments include Quality of Life via NCC-BC-A scale, safety analysis for AEs/SAEs, pharmacokinetic parameters (clearance, volume of distribution), and immunogenicity measurement (anti-drug antibodies), with evaluations spanning approximately 28 months.

Eligible patients require histopathologically confirmed salivary gland carcinoma with specific biomarker testing, good ECOG status (0-1), measurable lesions per RECIST 1.1, and adequate organ function. Exclusions include treatment allergies, recent major surgery/vaccination, active infections, major cardiovascular diseases, uncontrolled comorbidities, or pregnancy/breastfeeding.