OKI-219 for Breast Cancer

(PIKture-01 Trial)

Recruiting at 32 trial locations

Overseen By OnKure, Inc.

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: OnKure, Inc.

Must be taking: GnRH agonists

Must not be taking: Corticosteroids, PPIs

Disqualifiers: Diabetes, Cardiovascular disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: Up to 28 weeks for dose escalation and optimization

150 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial protocol does not specify if you must stop taking your current medications. However, you cannot use proton pump inhibitors, certain enzyme inhibitors or inducers, or specific drug transporter substrates within one week before starting the study drug.

What is the purpose of this trial?

OKI-219-101 is a Phase 1a/1b, open-label, multicenter, dose-escalation study designed to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PDx), and efficacy of OKI-219 as monotherapy and in combination with fulvestrant or trastuzumab. Phase 1a (Part A) will investigate escalating doses of OKI-219 monotherapy, and Phase 1b will investigate OKI-219 (at a tolerated dose determined in Part A) in combination with standard dose fulvestrant (Part B) or standard dose trastuzumab (Part C). Participants will continue to receive study treatment until disease progression, intolerable toxicity, or other study treatment withdrawal criteria are met.

Eligibility Criteria

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.

Inclusion Criteria

My condition matches the specific requirements for this study's phase and group.

I can swallow and tolerate pills.

Participants must have at least 1 measurable lesion based on RECIST version 1.1

Exclusion Criteria

History of symptomatic drug-induced pneumonitis

Positive hepatitis B virus (HBV) core antibody or hepatitis C virus (HCV) antibody

I have heart problems or significant heart disease.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive OKI-219 as monotherapy or in combination with fulvestrant or trastuzumab, with dose escalation and optimization phases

Up to 28 weeks for dose escalation and optimization

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessment of adverse events and pharmacokinetics

30 days after last dose

Long-term Follow-up

Participants are monitored for progression-free survival and other long-term outcomes

Up to approximately 36 months

Treatment Details

Interventions

• OKI-219

Trial Overview 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.

Participant Groups

Group I: Phase 1b: Part C Dose Optimization Experimental Treatment 2 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 Escalation Experimental Treatment 2 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 Optimization Experimental Treatment 2 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 Escalation Experimental Treatment 2 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 Escalation Experimental Treatment 1 Intervention

OKI-219 Monotherapy Dose Escalation in participants with advanced solid tumors with the PI3Kα1047R mutation

Who Is Running the Clinical Trial?

OnKure, Inc.

Lead Sponsor

Trials

3

Recruited

220+