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

Part of paid clinical trials in Scottsdale, Arizona.

Sponsor
VM Discovery, Inc.
Study ID
NCT07636785
Phase
PHASE1/PHASE2
Status
Not Yet Recruiting

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Conditions

  • Colorectal Cancer (CRC)
  • Hepatocellular Carcinoma (HCC)
  • Metastatic Uveal Melanoma
  • Nonsmall Cell Lung Cancer
  • Renal Cell Carcinoma (RCC)

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • VMD-102 — DRUG
    A small organic molecule oral drug in the tablet form

Study Details

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.

Key Dates

Start date
Jun 30, 2026
Status verified
Jun 2026
Primary completion
May 31, 2031
Completion
Dec 31, 2031

Study Design

Enrollment
111 participants (estimated)
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Phase 1 and Phase 2
    Phase 1: The dose escalation will evaluate escalating dose levels of VMD-102 in approximately 25 participants. This phase will assess the safety, pharmacokinetics and tolerability of VMD-102 during cycle 1 (of 21-day cycle) with participants of advanced HCC, MUM, RCC, NSCLC, and CRC to determine the maximum tolerated dose (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.

Primary Outcome Measure

Number and severity of treatment-emergent adverse events (TEAE) (Phase 1) [ Time Frame: First cycle (21 days per cycle) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
HonorHealth Research InstituteScottsdaleArizona85258
Study Coordinator
[email protected]
480-323-1350
Justin C Moser, MD (PRINCIPAL_INVESTIGATOR)

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By research site
HonorHealth Research Institute· Scottsdale, AZ

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