VMD-102 for Liver Cancer
(SPKTAHC Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new treatment called VMD-102 to determine its safety and effectiveness for individuals with certain advanced cancers, such as liver cancer, that have not responded to standard treatments. The study will examine the drug's interaction with the body and its impact on tumor growth. Individuals with advanced liver cancer or other specified cancers who have not found success with conventional treatments may be suitable candidates for this trial. As a Phase 1 trial, the research aims to understand how the treatment works in people, providing participants the opportunity to be among the first to receive this new drug.
Do I need to stop my current medications for the trial?
The trial does not specify if you need to stop taking your current medications. However, if you are on certain medications like potent P-glycoprotein inhibitors, you may need to stop them 3 days before starting the trial. It's best to discuss your specific medications with the trial team.
Is there any evidence suggesting that VMD-102 is likely to be safe for humans?
Research shows that VMD-102 is undergoing its first human trials. Earlier lab studies, particularly with mice, indicated its potential in fighting tumors. These studies also explored the mechanism and safety of VMD-102, suggesting it might be safe for humans.
However, as this is an early human trial, detailed safety information is not yet available. The current trial will assess how well participants tolerate the treatment and identify any side effects. This will help researchers determine the safest dose for future studies. Participants in this study play a crucial role in understanding the safety of VMD-102.12345Why do researchers think this study treatment might be promising?
Researchers are excited about VMD-102 for liver cancer because it offers a new approach compared to current treatments like surgery, chemotherapy, and targeted therapies such as sorafenib or lenvatinib. Unlike these standard options that often have broad systemic effects, VMD-102 is designed to target specific cancer markers, potentially leading to more precise and less toxic treatment. Additionally, its novel mechanism of action focuses on disrupting cancer cell growth at a molecular level, which could enhance its effectiveness against tumors that are resistant to existing therapies. This targeted strategy may also allow for the identification of biomarkers that predict patient response, paving the way for more personalized treatment plans.
What evidence suggests that VMD-102 might be an effective treatment for liver cancer?
Research shows that VMD-102, which participants in this trial may receive, may help fight liver cancer. In studies with mice, it effectively stopped a protein called PKC epsilon, linked to cancer growth. This suggests VMD-102 might slow or stop the spread of cancer cells. Although early lab results are promising, more information from human studies is necessary. The researchers aim for these findings to lead to an effective treatment for liver cancer patients.12678
Who Is on the Research Team?
Jay Wu, PhD
Principal Investigator
VM Discovery, Inc.
Are You a Good Fit for This Trial?
This trial is for adults with advanced or metastatic liver, kidney, lung, colorectal, or eye cancer that has not responded to standard treatments. Participants must be in good physical condition (able to care for themselves), have at least one measurable tumor, and meet certain blood and liver function requirements.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Phase 1 Treatment
Dose escalation to evaluate safety, pharmacokinetics, and tolerability of VMD-102 during cycle 1 (21-day cycle) to determine the maximum tolerated dose and recommended Phase 2 dose
Phase 2 Treatment
Dose expansion to assess anti-tumor activity and safety of VMD-102 in two cohorts after determining RP2D
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- VMD-102
Trial Overview
The study is testing a new drug called VMD-102—the first of its kind targeting PKC epsilon—in people with various advanced cancers. The trial will first find the safest dose (Phase 1) and then see if it helps shrink tumors (Phase 2).
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
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.
Find a Clinic Near You
Who Is Running the Clinical Trial?
VM Discovery, Inc.
Lead Sponsor
Citations
A Phase 1 and 2 Study of VMD-102 in Hepatocellular ...
This study is to evaluate the safety and tolerability to determine (i) the recommended Phase 2 dose (RP2D) of VMD-102 (Phase 1), ...
Global Advances in Hepatocellular Carcinoma Research and ...
In this study, the 5‐year overall survival (OS) rate of more than 35,000 patients who had undergone surgery for HCC was 69.1%, which further ...
VMD-102 for Liver Cancer · Info for Participants
VMD-102 anti-tumor activities in mouse liver/HCC tumor models and preclinical toxicology and pharmacology studies support this study.
Hepatocellular Carcinoma (HCC)
Lenvatinib and pembrolizumab plus transarterial chemoembolization improved PFS in intermediate-stage HCC, according to data from LEAP-012 shared at ESMO 2024.
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Updated efficacy and safety data from IMbrave150: Atezolizumab plus bevacizumab vs. sorafenib for unresectable hepatocellular carcinoma. J. Hepatol. 2022;76 ...
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