drugset / Trial / NCT06004245
A Study to Evaluate the Safety, Pharmacokinetics, and Anti-Tumor Activity of VVD-133214 as Monotherapy and in Combination in Participants With Advanced Solid Tumors
Non-randomizedSequentialOpen-labelTreatment
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 bevacizumab or 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.
Timeline
- Start
- 2024-01-25
- Primary completion
- 2027-05-31
- Completion
- 2027-05-31
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Bevacizumab | Monoclonal antibody | 7.5 mg/kg | Intravenous |
| Subject | Pembrolizumab | Monoclonal antibody | 200 mg | Intravenous |
| Subject | VVD-133214 | Unknown | — | Oral |