A Phase 1 and 2 Study of VMD-102 in Hepatocellular Carcinoma and Other Solid Tumors
NCT07636785 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 111
Last updated 2026-08-19
Summary
This study is to evaluate the safety and tolerability to determine (i) the recommended Phase 2 dose (RP2D) of VMD-102 (Phase 1), and (ii) preliminary anti-tumor efficacy (Phase 2), in participants with advanced HCC, metastatic uveal melanoma (MUM), renal cell carcinoma (RCC), non-small cell lung cancer (NSCLC), and colorectal cancer (CRC). The pharmacokinetics (PK), preliminary anti-tumor activity, and potential biomarkers of VMD-102 will also be assessed.
VMD-102 will be the first selective PKC epsilon (PKCε or PKCe) kinase inhibitor to enter human clinical testing. Preclinical VMD-102 anti-tumor activities in mouse liver/HCC tumor models and preclinical toxicology and pharmacology studies support this study.
Conditions
- Hepatocellular Carcinoma (HCC)
- Metastatic Uveal Melanoma
- Renal Cell Carcinoma (RCC)
- Nonsmall Cell Lung Cancer
- Colorectal Cancer (CRC)
Interventions
- DRUG
-
VMD-102
A small organic molecule oral drug in the tablet form
Sponsors & Collaborators
-
VM Discovery, Inc.
lead INDUSTRY
Principal Investigators
-
Jay Wu, PhD · VM Discovery, Inc.
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SEQUENTIAL
Eligibility
- Min Age
- 18 Years
- Max Age
- 75 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2026-07-16
- Primary Completion
- 2031-05-31
- Completion
- 2031-12-31
- FDA Drug
- Yes
Countries
- United States
Study Locations
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