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

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 either alone (monotherapy) or

Trial Details

NCT ID
NCT06789172
Phase
PHASE1
Sponsor
Epkin
Status
RECRUITING
Cancer Type
Liposarcoma Sarcoma
Interventions
  • OKN4395
  • Pembrolizumab
  • Fasting
  • Fed
  • H2 Receptor Antagonist
Locations (sample)
  • Beverly Hills, California, United States|34.07362,-118.40036
  • Santa Monica, California, United States|34.01949,-118.49138
  • Houston, Texas, United States|29.76328,-95.36327
  • Sydney, New South Wales, Australia|-33.86785,151.20732
  • Perth, Western Australia, Australia|-31.95224,115.8614

Key Eligibility Criteria

  • 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 …
  • For Phase 1b:

For full eligibility, visit ClinicalTrials.gov.

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