Phase 1/2 VMD-102 selective PKCε (protein kinase C epsilon) inhibitor in HCC and solid tumors.

This first-in-human, open-label, multicenter Phase 1/2 study sponsored by VM Discovery evaluates VMD-102, a selective PKC epsilon (PKCε) kinase inhibitor intended to suppress oncogenic PKC signaling that can promote tumor cell survival, growth, and invasion. Phase 1 uses dose escalation (25 participants; 21-day cycles) to characterize safety/tolerability and pharmacokinetics and to establish the maximum tolerated dose and recommended Phase 2 dose. Phase 2 expands using a Bayesian Optimal Phase II (BOP2) design (86 total across two cohorts) to estimate preliminary anti-tumor activity and further safety in advanced/unresectable hepatocellular carcinoma (Child-Pugh up to 7 depending on phase) and a mixed cohort including metastatic uveal melanoma, renal cell carcinoma, non-small cell lung cancer, and colorectal cancer; biomarker-guided enrollment may be added later. Clinically, these populations typically receive systemic therapy matched to disease context—e.g., HCC often uses immunotherapy + anti-VEGF or TKIs; RCC often uses IO/TKI combinations; metastatic uveal melanoma has limited effective systemic options—so the commercial/scientific angle is testing the first selective PKCε inhibitor in humans across multiple hard-to-treat settings.