A Phase 1 Trial of OKN4395 and Pembrolizumab
Phase 1
166
about 3.7 years
18+
3 sites in CA, TX
About this study
This trial is testing a new treatment called OKN4395, given alone or with pembrolizumab, in people with solid tumors. The goal is to see if the treatment is safe and how it works in the body. This will involve different doses of OKN4395 administered over 1346 days.
Based on ClinicalTrials.gov records.
What participants do
- 1.Fasting
- 2.Fed
- 3.Take H2 Receptor Antagonist
- +2 more
Participation effort
Estimated from trial records. Details can vary by site.
Logistics difficulty varies by site location and availability.
Trial highlights
Treatment details
Auto-extracted from trial records to preview treatments and outcomes.
pembrolizumab (Immune checkpoint inhibitor; blocks PD-1 to boost T-cell attack on cancer)
infusion
Primary: Incidence and severity of SAEs in participants treated with OKN4395 as a monotherapy and in combination with pembrolizumab in solid tumors. (Phase 1a), Incidence and severity of TEAEs in participants treated with OKN4395 as a monotherapy and in combination with pembrolizumab in solid tumors. (Phase 1a), To assess the overall response rate in participants treated with OKN4395 as monotherapy and in combination with pembrolizumab in selected cancer types. (Phase 1b)
Secondary: Incidence and severity of SAEs in participants treated with OKN4395 as a monotherapy and in combination with pembrolizumab in solid tumors. (Phase 1b), Incidence and severity of TEAEs in participants treated with OKN4395 as a monotherapy and in combination with pembrolizumab in solid tumors. (Phase 1b), To assess the disease control rate at >=12 weeks in participants treated with OKN4395 as monotherapy and in combination with pembrolizumab in selected cancer types. (Phase 1a), To assess the disease control rate at >=12 weeks in participants treated with OKN4395 as monotherapy and in combination with pembrolizumab in selected cancer types. (Phase 1b), To assess the duration of response in participants treated with OKN4395 as monotherapy and in combination with pembrolizumab in selected cancer types. (Phase 1a), To assess the duration of response in participants treated with OKN4395 as monotherapy and in combination with pembrolizumab in selected cancer types. (Phase 1b), To assess the overall response rate in participants treated with OKN4395 as monotherapy and in combination with pembrolizumab in selected cancer types. (Phase 1a), To assess the overall survival rate at 24 weeks in participants treated with OKN4395 as monotherapy and in combination with pembrolizumab in selected cancer types. (Phase 1a)
Oncology