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A Study to Evaluate the Safety, Pharmacokinetics, and Anti-Tumor Activity of VVD-133214 as Monotherapy and in Combination With Pembrolizumab in Participants With Advanced Solid Tumors
NCT06004245 · View on ClinicalTrials.gov ↗
Study Summary
This is a first-in-human, Phase I, open-label, multicenter, dose-escalation and dose expansion study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary anti-tumor activity of VVD-133214 monotherapy, and in combination with pembrolizumab, in participants with microsatellite instability (MSI) and/or deficient mismatch repair (dMMR) advanced solid tumors. VVD-133214 is an oral drug that acts on a protein called Werner (WRN), which may promote the growth of cancers that are MSI and/or dMMR. By acting on WRN, VVD-133214 may be able to block the growth of these types of cancer.
Conditions Studied
Interventions
- DRUG Pembrolizumab
- DRUG VVD-133214
Study Locations (20)
Other
- UZ Leuven Gasthuisberg — Leuven
- Rigshospitalet — København Ø
- CLCC Leon Berard Lyon — Lyon
- Gustave Roussy — Villejuif
- Seoul National University Bundang Hospital — Seongnam-si
- Seoul National University Hospital — Seoul
- Asan Medical Center — Seoul
California
- City of Hope Cancer Center — Duarte
- City of Hope - Santa Clarita — Valencia
Madrid
- Clinica Universidad de Navarra Madrid — Madrid
- START Madrid. Centro Integral Oncologico Clara Campal — Madrid
Kentucky
- Norton Cancer Institute - MDC — Louisville
North Carolina
- Duke University — Durham
Oklahoma
- Oklahoma University Health Sciences Center — Oklahoma City
Tennessee
- SCRI Oncology Partners — Nashville
Texas
- MD Anderson Cancer Center — Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 295 participants |
| Start Date | 2024-01-25 |
| Est. Completion | 2027-05-31 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06004245
The ClinicalTrials.gov registry entry for NCT06004245 describes a study currently listed as recruiting. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 295 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Vividion Therapeutics, which has 4 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Advanced Solid Tumors appearing as the primary indexed condition, and to 2 interventions — of which Pembrolizumab is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT06004245 reports 20 study locations spanning 12 distinct geographic areas — top geographies include Other, California, Madrid. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT06004245 about?
NCT06004245 is a clinical study titled "A Study to Evaluate the Safety, Pharmacokinetics, and Anti-Tumor Activity of VVD-133214 as Monotherapy and in Combination With Pembrolizumab in Participants With Advanced Solid Tumors". This is a first-in-human, Phase I, open-label, multicenter, dose-escalation and dose expansion study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary anti-tumor activity of VVD-133214 monotherapy, and in combination with pembrolizumab, in participants with mi...
What is the current status of trial NCT06004245?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 295 participants. The study started on 2024-01-25. Estimated completion is 2027-05-31.
What conditions does trial NCT06004245 study?
This clinical trial studies the following conditions: Advanced Solid Tumors. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT06004245?
The interventions under investigation include: Pembrolizumab (DRUG), VVD-133214 (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT06004245?
This trial is sponsored by Vividion Therapeutics, which has 4 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT06004245 being conducted?
This trial has 20 study locations across California, Kentucky, North Carolina, Oklahoma, Tennessee. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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