Not Yet RecruitingPhase 1/2

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

United States111 participantsStarted 2026-06

Plain-language 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.

Who can participate

Age range

18 Years – 75 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Histological or cytological or radiological diagnosis of advanced (unresectable and/or metastatic) HCC, MUM, RCC, NSCLC and CRC that is not responsive to standard of care (SOC), had progressed following SOC, is intolerant to SOC, or for whom the SOC is not considered appropriate by the investigator. * Eastern Cooperative Oncology Group (ECOG) Performance Status 0, or 1. * Has at least one measurable target lesion according to RECIST v1.1 \[Response Evaluation Criteria In Solid Tumors\], or mRECIST \[modified RECIST\] for unresectable HCC participants, and either (a). has not been previously treated with local therapy (e.g., radiation therapy, hepatic arterial embolization, radiofrequency ablation, and percutaneous interventional therapy), or (b). if the target lesion was within the field of local therapy, the lesion has shown an increase in size of 25% or greater following local therapy. * Adequate organ function evidenced by: Hematology * Hemoglobin ≥ 9 g/dL (SI Units: 90 g/L) (post-transfusion if transfusion-dependent) * Platelet count ≥ 60000/mm3 (60 x109/L) without support(transfusion) within 7 days of testing * Absolute neutrophil count (ANC) ≥ 1500/mm3 (1.5x109/L) Chemistry * Total bilirubin (TBIL) ≤ 2.0 x upper limit of normal (ULN). (For participants with Gilbert's syndrome, TBIL ≤3.0 x ULN provided that direct bilirubin DBIL) is \<30% of the TBIL) * Aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) 1 ≤ 5 x U LN (participa…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Since this trial is still in Phase 1 and hasn't started recruiting yet, what does that mean for how much is currently known about VMD-102's safety profile, and is now the right time for me to be considering it given my diagnosis?
2The Phase 1 part of this study is specifically focused on finding the right dose and identifying side effects — so if I were to enroll in that phase, could I end up receiving a dose that turns out to be too low to be effective, or one that causes significant toxicity before the safe dose is established?
3This trial covers several different cancer types including hepatocellular carcinoma, uveal melanoma, and renal cell carcinoma — do you think my specific cancer type and current stage make me a realistic candidate to discuss with the trial team once recruiting opens?
4Before this trial becomes available, are there standard-of-care treatments or other currently recruiting studies I should consider first, so I'm not waiting on a trial that hasn't started yet?
5Since Phase 2 will be measuring progression-free survival, and the trial hasn't even begun recruiting yet, how long do you estimate it might realistically be before I could access VMD-102, and does that timeline make sense given how quickly my condition may need to be treated?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Number and severity of treatment-emergent adverse events (TEAE) (Phase 1)

Timeframe: First cycle (21 days per cycle)

To determine the recommended Phase 2 dose (RP2D) for VMD-102 (Phase 1)

Timeframe: First cycle (21 days per cycle)

Progression-Free Survival (PFS) (Phase 2)

Timeframe: Up to 18 months

Trial details

NCT IDNCT07636785

SponsorVM Discovery, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2031-05

Contact for this trial

Jay Wu, PhD

+1-510-661-6770 ext. 101 OM@VMDiscovery.com

View on ClinicalTrials.gov More Hepatocellular Carcinoma (HCC) trials