First-in-Human Study of OKI-219
Phase 1
200
about 3.4 years
18+
13 sites in CA, CO, MA +6
What this study is about
This trial is testing a new drug called OKI-219 in people with advanced cancer. The goal is to see if it's safe and how well it works, as well as how the body processes the drug. Participants will receive different combinations of OKI-219 with other medications until their disease progresses or they can no longer tolerate the treatment.
Simplified from trial records by PatientMatch.
What you may be asked to do
- 1.Take Atirmociclib
- 2.Take Fulvestrant
- 3.Take OKI-219
- +3 more
Participation Burden
What's physically and logistically required of participants.
Requires travel to a study site
How treatment is administered
You are randomly assigned, but you will know your treatment.
Extracted study details
Pulled from the trial record to show what is being tested and what the study is measuring.
cdk inhibitor, fulvestrant, ribociclib, trastuzumab (Monoclonal antibody; targets HER2 protein on cancer cells), tucatinib
injection, oral (Oral Tablet), intravenous
Primary: Assess safety of OKI-219 as monotherapy or in combination with other anti-cancer therapies: incidence of Grade 2 or greater treatment emergent adverse events, Assess safety of OKI-219 as monotherapy or in combination with other anti-cancer therapies: incidence of SAEs, Identify maximum tolerated dose (MTD) of OKI-219 in monotherapy
Secondary: Assess the plasma PK of OKI-219 following single and multiple doses as monotherapy or in combination with other anti-cancer therapies: area under the plasma concentration-time curve (AUC), Assess the plasma PK of OKI-219 following single and multiple doses as monotherapy or in combination with other anti-cancer therapies: maximum plasma concentration (Cmax), Assess the plasma PK of OKI-219 following single and multiple doses as monotherapy or in combination with other anti-cancer therapies: terminal elimination half-life time (t1/2), Assess the plasma PK of OKI-219 following single and multiple doses as monotherapy or in combination with other anti-cancer therapies: time of maximum plasma concentration (Tmax), Dose optimization only: to estimate the preliminary antitumor activity of OKI-219 as monotherapy and in combination with other anti-cancer therapies: progression free survival (PFS), To estimate the preliminary antitumor activity of OKI-219 as monotherapy and in combination with other anti-cancer therapies: objective response rate (ORR)
Oncology