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NCT06004245 · ClinicalTrials.gov registry record · Phase 1
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
A Phase 1 study of Advanced Solid Tumors, sponsored by Vividion Therapeutics.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 295
- Enrollment target
- 20
- Study locations
NCT06004245: Recruiting Phase 1 study of Advanced Solid Tumors, sponsored by Vividion Therapeutics.
NCT06004245 is a Phase 1 study of Advanced Solid Tumors that is actively recruiting participants, run by Vividion Therapeutics. The registered enrollment target is 295 participants, above the 197-participant average among 144 other Advanced Solid Tumors trials with a reported enrollment target (50% higher). The trial reports 20 study locations across 12 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06004245, a Phase 1 study of Advanced Solid Tumors, is actively recruiting participants, sponsored by Vividion Therapeutics.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 295 participants
- Enrollment target
- 20
- Study locations
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 |
What NCT06004245 shows while recruiting
NCT06004245 is an interventional study that assigns participants to a tested intervention. The registered 295 participants enrollment target is mid-sized for trials with a published cap, above the 197-participant average among 144 other Advanced Solid Tumors trials with a reported enrollment target (50% higher).
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.
NCT06004245 names 20 study sites across 12 states, led by Other, California, Madrid.
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.
What interventions are being tested in trial NCT06004245?
The interventions under investigation include: Pembrolizumab (DRUG), VVD-133214 (DRUG).
Who is sponsoring clinical trial NCT06004245?
This trial is sponsored by Vividion Therapeutics, which has 4 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
Similar trials for Advanced Solid Tumors
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06004245's enrollment target sits among peer trials
295 26th of 144 higher than 119 of 144 other Advanced Solid Tumors trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Advanced Solid Tumors trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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