ClinicaliQ Trial Snapshot
- A Phase 1, First-in-human Study of OKN4395 and Pembrolizumab in Patients With Solid Tumors — Recruiting • Phase I • Oncology • NCT06789172.
- What is being tested: OKN4395, a novel investigational drug, is being evaluated as monotherapy and in combination with pembrolizumab (an established PD-1 checkpoint inhibitor) to assess safety, tolerability, and preliminary efficacy in patients with solid tumors.
- Patient eligibility overview: This Phase 1 first-in-human trial enrolls patients with solid tumors; eligibility typically includes those with advanced or metastatic disease, adequate organ function, and prior treatment experience, though specific criteria would be detailed in the full protocol.
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- Quick orientation before opening the registry record.
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What This Trial Is Studying
The purpose of this study is to investigate the study drug, OKN4395, administered alone and in combination with pembrolizumab. The overall objectives of this study are to determine the safety and tolerability (degree to which side effects of a drug can be tolerated) of OKN4395 alone and in combination with pembrolizumab, OKN4395 and metabolites (broken-down substances) of OKN4395 levels in the blood, and antitumor activity of OKN4395 alone and in combination with pembrolizumab. This study will be split into 2 parts. Part 1a will look at multiple doses of OKN4395…
Eligibility Snapshot
- : 1. Histologically or cytologically confirmed disease, locally advanced or metastatic: For Phase 1a: Solid tumor with a COX2-associated immunosuppressive pathway, for which standard treatment options are not available, no longer effective, refused or not tolerated. For Phase 1b: For all cohorts, in the opinion of the investigator, all appropriate authorised treatment options should be exhausted * Cohort 1: Sarcoma (fibrous sarcoma [myxofibrosarcoma or solitary fibrous tumor], dedifferentiated liposarcoma, undifferentiated pleomorphic sarcoma or pleomorphic sarcoma), that is either refractory to or progressing on standard of care, with no more than 3 prior lines of systemic therapy. Patients with a solitary fibrous tumor can be included in the study without prior treatment if, in the investigator's opinion, it is in the participant's best interest and no established standard of care exists or is available. * Cohort 2: Pancreatic adenocarcinoma, with no more than 3 prior lines of systemic therapy. When known, KRAS and BRCA status should be provided. * Cohort 3: NSCLC (squamous or adenomatous without EGFR/ALK mutations), with previous platinum-based chemotherapy and a previous PD-(L)1 CPI regimen (unless not eligible/unwilling to receive such therapies), and no more than 3 prior lines of systemic therapy. When known, PD-L1 status should…
Use the source registry for the full inclusion and exclusion criteria before discussing referral or enrolment.