Phase 1 Study to Assess Safety and Effects of VVD-130037 Alone and with Docetaxel, Paclitaxel, or Pembrolizumab in Adults with Advanced Solid Tumors

What this Trial Is About

Researchers are evaluating VVD-130037, a Kelch-like ECH Associated Protein 1 KEAP1 activator, in adults with advanced solid tumors in a first-in-human study. The study aims to assess the safety, tolerability, pharmacokinetics, pharmacodynamics, and early anti-tumor activity of VVD-130037, both alone and combined with other cancer treatments. This is an open-label, phase 1 trial sponsored by Vividion Therapeutics, Inc., focusing on patients whose cancer has progressed despite prior standard therapies. Participants receive escalating doses of VVD-130037 orally once or twice daily in 21- or 28-day treatment cycles. In Part 1 dose escalation, VVD-130037 is tested alone and combined with intravenous docetaxel, paclitaxel, or pembrolizumab at established schedules. Part 2 dose expansion administers VVD-130037 at the recommended dose for expansion RDE, alone or in combination, to further evaluate safety and activity. Treatment cycles vary by combination, with docetaxel given every 3 weeks and paclitaxel given on days 1, 8, and 15 of each cycle. Participants undergo regular assessments including monitoring for dose-limiting toxicities during the first treatment cycle and tracking adverse events over up to 4 years. Laboratory tests, electrocardiograms, and imaging evaluations measure drug concentrations, heart rhythm, and tumor response. Researchers also evaluate overall response rates, duration of response, progression-free survival, and disease control rates. Safety follow-up and detailed pharmacokinetic studies are part of the long-term observation to understand the effects of VVD-130037 and its combinations.

A First-in-Human (FIH) Study to Evaluate the Safety and Tolerability of VVD-130037 in Participants With Advanced Solid Tumors