A Phase 1 Trial of OKN4395 and Pembrolizumab
Phase 1
166
about 3.7 years
18+
3 sites in CA, TX
What this study is about
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.
Simplified from trial records by PatientMatch.
What you may be asked to do
- 1.Fasting
- 2.Fed
- 3.Take H2 Receptor Antagonist
- +2 more
Participation Burden
What's physically and logistically required of participants.
Requires travel to a study site
How treatment is administered
Everyone gets the investigational treatment.
Extracted study details
Pulled from the trial record to show what is being tested and what the study is measuring.
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