Recruiting nowPhase 2
What this trial is trying to do
The researchers are testing VMD-102, described as a selective inhibitor of PKC epsilon, a kinase involved in cell signalling, in people with advanced colorectal cancer and several other solid tumours. They will first establish a tolerable dose and then look for early signs of anti-tumour activity, as well as how the drug behaves in the body and possible biomarkers.
The idea is that blocking PKC epsilon may interfere with signals that help tumour cells survive or grow. The trial is not comparing VMD-102 with another treatment; it will mainly measure treatment-related side effects in Phase 1 and preliminary tumour activity in Phase 2, rather than showing whether it helps people live longer.
Worth knowing: This is a small, non-randomised early-phase study, and the first phase is primarily testing safety and dose rather than benefit.
Written from the trial's own registry entry to explain what the researchers are testing and why. Nothing here is a result — this trial has not reported one — and it is not a view on whether the treatment works or on whether it would suit you.
| Registry number | NCT07636785 |
|---|---|
| Recruitment | Recruiting now |
| Phase | Phase 2 |
| Design | open label |
| Taking part | 111 people (planned) |
| Who can join | aged 18 Years to 75 Years |
| Run by | VM Discovery, Inc. |
| Started | |
| Main results expected | |
| Record last updated |
What is being tested
- Drug VMD-102
What it is measuring
Number and severity of treatment-emergent adverse events (TEAE) (Phase 1)
This is the trial's main question — the one it is designed and sized to answer. Anything else it reports is a secondary finding, and secondary findings are far more likely to be chance.
Phase 2. Tests whether the treatment works well enough to be worth a larger trial. Usually too small to prove it changes survival.
How the researchers describe it
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.
Written by the trial’s sponsor, quoted from its ClinicalTrials.gov record.
What this trial is looking for
- Any genotype
- Metastatic
Read automatically from the criteria below, to make the list searchable. It is a summary of what the text mentions, not a decision about whether you qualify — and where the two disagree, the criteria are right and this is wrong.
Who the trial is looking for
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 (1.5×109/L) Chemistry
- Total bilirubin (TBIL) ≤ 2.0 x upper limit of normal (ULN).
This is an extract. Whether you qualify is decided by the trial team against the full criteria, not by reading this page. Read the full eligibility criteria
Where it is running
Running at 1 site. Listed in: United States.
Individual hospitals, and whether each is currently open, are listed on the registry record. Sites open and close throughout a trial.
Worth asking your oncology team
Being listed here is not a recommendation, and no one page can tell you whether a trial is right for you. These are the questions it raises.
- Is this trial open at a hospital I could realistically travel to?
- Given my stage, my previous treatment and my tumour's molecular profile, would I be eligible?
- What would I be giving up by joining — is the comparison arm the treatment I would otherwise be having?
- What is already known about the safety of what is being tested?
The source
Registry record NCT07636785, registered by VM Discovery, Inc. on ClinicalTrials.gov, a public database run by the US National Library of Medicine. The details on this page come from that record and are only ever as current as the sponsor has kept it.
This is a listing of a registered clinical trial, reproduced for information. It is not a recommendation, this site has no connection to the trial or its sponsor, and being listed here says nothing about whether the treatment works. Talk to your own oncology team before pursuing any trial.
This article summarises published research for general information. It is not medical advice, and it is not a substitute for a conversation with your own oncology team, who know your case. Do not start, stop, or change any treatment or supplement on the basis of what you read here.