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

NCT06004245 ↗

Phase 1 Recruiting 280 enrolled Vividion Therapeutics, Inc.
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

EvaluationDrugModalityDoseRoute
Subject Bevacizumab Monoclonal antibody 7.5 mg/kg Intravenous
Subject Pembrolizumab Monoclonal antibody 200 mg Intravenous
Subject VVD-133214 Unknown — Oral

Indications