Eligible patients must have advanced solid tumors with measurable disease (RECIST v1.1), ECOG 0-1, and adequate organ function. Exclusions include unresolved toxicities (>Grade 1, except alopecia), recent anticancer therapy (14-28 days prior), active brain metastases, uncontrolled comorbidities, cardiac disease, MDS/AML history, concurrent malignancies (except certain low-risk cases), and pregnancy/breastfeeding.

The study will assess the incidence and severity of adverse events (AEs) and serious adverse events (SAEs) graded by NCI-CTCAE v5.0 over 2 years, while determining Maximum Tolerated Dose (MTD) based on dose-limiting toxicities (DLTs) in the first 6 evaluable participants within 28 days, and Recommended Phase 2 Dose (RP2D) using safety, tolerability, and pharmacokinetic data.

Efficacy endpoints include Objective Response Rate (ORR), Duration of Response (DOR), Progression-Free Survival (PFS), Time to Response (TTR), 1-Year and 2-Year Overall Survival (1YOS, 2YOS), and immunogenicity via anti-drug antibody (ADA) assessment. Pharmacokinetic parameters [Cmax, Cmin, AUC, t1/2, CL, Vz, Rac, etc.] for TORL-3-600 will be evaluated over 21-63 days.