Phase 1 Study Evaluating OKN4395 Alone or with Pembrolizumab in Adults with Advanced Solid Tumors

What this Trial Is About

Researchers are investigating the drug OKN4395, alone and combined with pembrolizumab, in adults with advanced solid tumors. This Phase 1 study aims to assess the safety, tolerability, blood levels, and anti-tumor activity of OKN4395 both as a single treatment and alongside pembrolizumab. The study focuses on tumors with a COX2-associated immunosuppressive pathway and includes multiple cancer types such as sarcoma, non-small cell lung cancer, colorectal cancer, and gastric cancer. The study is divided into two main parts. Part 1a includes dose escalation of OKN4395 alone or with pembrolizumab every 21 days, increasing doses based on safety evaluations, and a substudy testing how food and stomach acid affect OKN4395 blood levels. Part 1b evaluates OKN4395 alone or combined with pembrolizumab in four cancer cohorts. Participants receive oral OKN4395 twice daily, with pembrolizumab given intravenously every three weeks where applicable. The substudy involves dosing under fasting, fed, and high stomach pH conditions using famotidine. Participants will be monitored through regular visits lasting up to 27 months for Part 1a and up to 12 months for Part 1b. Assessments include safety checks for side effects, blood tests for drug levels and lab abnormalities, ECGs, tumor measurements, and evaluation of treatment response and progression. The study tracks dose adjustments, adverse events, and survival outcomes to understand the drugs effects and tolerability in solid tumor patients.

A Phase 1, First-in-human Study of OKN4395 and Pembrolizumab in Patients With Solid Tumors