A Phase 1, Open-label, Dose-escalation and Cohort Expansion Study of OKN4395 Alone and With Pembrolizumab in Advanced Solid Tumors

What this Trial Is About

Researchers are investigating the study drug OKN4395 alone and in combination with pembrolizumab in patients with advanced solid tumors. The study aims to assess the safety, tolerability, blood levels of OKN4395 and its metabolites, and the antitumor activity of these treatments. This phase 1 study focuses on patients whose tumors involve a COX2-associated immunosuppressive pathway and includes various cancer types such as sarcoma, pancreatic adenocarcinoma, non-small cell lung cancer, colorectal cancer, and head and neck squamous cell carcinoma. The study consists of two parts. Part 1a involves dose escalation of OKN4395 alone or with pembrolizumab given on day 1 of each 21-day cycle to determine the optimal dose, with doses ranging from 10 mg twice daily up to 450 mg twice daily. Part 1b includes five cohorts with specific cancer types receiving OKN4395 alone or combined with pembrolizumab to evaluate treatment effects and explore factors like food and gastric pH on OKN4395 blood levels. Participants continue treatment until disease progression or for other reasons. Participants will undergo safety and response assessments including monitoring of dose-limiting toxicities, treatment-emergent adverse events, laboratory tests, ECGs, and vital signs over up to 27 months in Part 1a and up to 12 months in Part 1b. Researchers will also evaluate overall response rates, disease control, progression-free survival, and pharmacokinetics of OKN4395. The study involves multiple visits for treatment and evaluations, with careful observation of side effects and tumor responses throughout the trial period.

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