A Phase 1 and 2 Study of VMD-102 in Hepatocellular Carcinoma and Other Solid Tumors

Phase 1: The Phase 1 dose escalation will evaluate escalating dose levels of VMD-102 in approximately 25 evaluable participants. This phase will assess the safety, PKs and tolerability of VMD-102 during cycle 1 (of 21-day cycle). Dose escalation will be guided according to the Bayesian Optimal Interval (BOIN) design to determine the next dose level based on dose-limiting toxicity (DLT) occurrence with participants of advanced HCC, MUM, RCC, NSCLC, and CRC to determine the MTD and the RP2D. Retrospective biomarker studies for the preclinical identified biomarkers may be carried out from tumor tissue and blood samples collected from participants. Phase 2: The Phase 2 dose expansion will employ a Bayesian Optimal Phase II (BOP2) design to enroll participants to assess the anti-tumor activity and safety of VMD-102 in Cohort 1 (approximately 43) participants with HCC, and Cohort 2 (approximately 43) participants with MUM, RCC, NSCLC and CRC. A biomarker guided enrollment criterion may be added via amendment. For each of two cohorts, once RP2D is determined, the Phase 2 expansion may be opened in both cohorts parallelly.