Phase 11b Study of VVD-159642 Alone or With Sotorasib or Trametinib in Adults With Advanced Solid Tumors

What this Trial Is About

Researchers are evaluating VVD-159642, a new drug that inhibits the RAS-PI3K pathway, in participants with advanced solid tumors. This first-in-human FIH Phase 11b study aims to assess the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary anti-tumor effects of VVD-159642 alone and combined with sotorasib or trametinib. The trial focuses on patients whose tumors have specific genetic alterations or overexpress certain proteins related to cancer growth. Participants will receive VVD-159642 orally once daily in 21-day treatment cycles. The study has two parts Part 1 involves dose escalation of VVD-159642 alone to find the recommended dose. Part 2 uses this dose to further assess VVD-159642 alone or combined with sotorasib or trametinib after safety evaluations. The combinations are also given orally daily in 21-day cycles. During the study, participants undergo regular monitoring for side effects, vital signs, and lab tests up to about 29 months. Researchers measure dose-limiting toxicities, adverse events, and drug levels in the blood. Tumor response and disease progression are assessed by imaging following RECIST criteria. This long-term follow-up helps understand the drugs safety and activity in advanced solid tumor patients.

A First-in-Human (FIH) Study to Evaluate the Safety and Tolerability of VVD-159642 in Participants With Advanced Solid Tumors