Eligible participants must be ≥18 years old with ECOG 0-1, adequate organ function, and tumor tissue availability (mandatory in some cohorts). Key exclusions include active CNS metastases (unless stable post-treatment), other malignancies within 2 years (exceptions apply), significant cardiac conditions (e.g., recent MI, symptomatic CHF), QTcF >470 ms, history of interstitial lung disease, or uncontrolled infections. Contraception requirements apply throughout and post-treatment (≥6 months for males, ≥7 months for females). Dose escalation requires progressing advanced cancers (e.g., ovarian, NSCLC, gastric), while expansion focuses on ovarian cancer with mandated biopsies when feasible.

The study evaluates safety through dose-limiting toxicities (DLTs) in the first two cycles (each cycle is 21 days) and treatment-emergent adverse events (TEAEs) from Cycle 1 Day 1 until 30 days post-last dose (up to 36 months). Efficacy is assessed via investigator-evaluated overall response rate (ORR) during treatment cycles, with tumor assessments every 6 weeks initially and every 12 weeks after 24 weeks.

Pharmacokinetic parameters (AUC, Cmax, Tmax, Ctrough) will be measured across multiple timepoints during Cycles 1-4 and beyond, with assessments continuing up to 36 months. Additional efficacy endpoints include duration of response (DoR), disease control rate (DCR), time to response (TTR), progression-free survival (PFS), and immunogenicity via anti-drug antibody (ADA) evaluation at scheduled intervals. Treatment cycles follow a 21-day schedule for all assessments.