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OKI-219 for Breast Cancer (PIKture-01 Trial)

Phase 1
Recruiting
Research Sponsored by OnKure, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through last study dose, an average of 1 year
Awards & highlights

Summary

This trial is testing a new drug called OKI-219 to see how safe and effective it is when used alone or in combination with other medications. The study will involve different phases where participants will receive

Who is the study for?
This trial is for adults with advanced solid tumors, especially breast cancer, that have specific genetic mutations or no standard treatment options. Breast cancer patients must have tried certain therapies unless contraindicated. Participants need a tumor suitable for biopsy and agree to ovarian suppression if needed.
What is being tested?
The study tests OKI-219 alone and combined with fulvestrant or trastuzumab in escalating doses to assess safety, tolerability, and effectiveness. Part A studies OKI-219 solo; Parts B & C test it with the other drugs at doses found safe in Part A until disease progression or unacceptable side effects occur.
What are the potential side effects?
Potential side effects of OKI-219, fulvestrant, and trastuzumab may include reactions at the infusion site, hormonal changes due to ovarian suppression therapy (if applicable), fatigue, nausea, and increased risk of infection.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through last study dose, an average of 1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and through last study dose, an average of 1 year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Assess rate of dose modifications during treatment with OKI-219 as monotherapy or in combination with fulvestrant or trastuzumab
Assess safety of OKI-219 as monotherapy or in combination with fulvestrant or trastuzumab: incidence of Grade 2 or greater treatment emergent adverse events
Assess safety of OKI-219 as monotherapy or in combination with fulvestrant or trastuzumab: incidence of SAEs
+1 more
Secondary study objectives
Assess the plasma PK of OKI-219 following single and multiple doses as monotherapy or in combination with fulvestrant or trastuzumab: 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 fulvestrant or trastuzumab: maximum plasma concentration (Cmax)
Assess the plasma PK of OKI-219 following single and multiple doses as monotherapy or in combination with fulvestrant or trastuzumab: terminal elimination half-life time (t1/2)
+7 more

Trial Design

5Treatment groups
Experimental Treatment
Group I: Phase 1b: Part C Dose OptimizationExperimental Treatment2 Interventions
OKI-219 + Trastuzumab Dose Optimization in participants with HR±/HER2+ locally advanced, unresectable or metastatic breast cancer with the PI3KαH1047R mutation
Group II: Phase 1b: Part C Dose EscalationExperimental Treatment2 Interventions
OKI-219 + Trastuzumab Dose Escalation in participants with HR±/HER2+ locally advanced, unresectable or metastatic breast cancer with the PI3KαH1047R mutation
Group III: Phase 1b: Part B Dose OptimizationExperimental Treatment2 Interventions
OKI-219 + Fulvestrant Dose Optimization in participants with HR+/HER2- locally advanced, unresectable or metastatic breast cancer with the PI3KαH1047R mutation
Group IV: Phase 1b: Part B Dose EscalationExperimental Treatment2 Interventions
OKI-219 + Fulvestrant Dose Escalation in participants with HR+/HER2- locally advanced, unresectable or metastatic breast cancer with the PI3KαH1047R mutation
Group V: Phase 1a: Part A Dose EscalationExperimental Treatment1 Intervention
OKI-219 Monotherapy Dose Escalation in participants with advanced solid tumors with the PI3Kα1047R mutation
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Fulvestrant
2011
Completed Phase 3
~3890
Trastuzumab
2014
Completed Phase 4
~5190

Find a Location

Who is running the clinical trial?

OnKure, Inc.Lead Sponsor
2 Previous Clinical Trials
70 Total Patients Enrolled
~100 spots leftby Jun 2026
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