NCT06239467

First-in-Human Study of OKI-219 in Advanced Solid Tumors and Advanced Breast Cancer

PIKture-01: First-in-Human Study of the PI3KαH1047R Mutant-Selective Inhibitor OKI-219 as Monotherapy in Participants With Advanced Solid Tumors and as Part of Combination Therapy in Participants With Advanced Breast Cancer

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: OnKure, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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 other anti-cancer drugs. 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 fulvestrant (Part B), trastuzumab and tucatinib (Part C), atirmociclib (Part D), and ribociclib and fulvestrant (Part E). Participants will continue to receive study treatment until disease progression, intolerable toxicity, or other study treatment withdrawal criteria are met.

Conditions

• Advanced Cancer
• Breast Cancer
• Advanced Solid Tumors
• PI3K Gene Mutation

Interventions

Type	Name	Description
DRUG	OKI-219	Oral twice daily
DRUG	Fulvestrant	Intramuscular injection
DRUG	Trastuzumab	Intravenous (IV)
DRUG	Tucatinib	Oral twice daily
DRUG	Atirmociclib	Oral twice daily
DRUG	Ribociclib	Oral once daily continuous for 21-days followed by 7 days off

Timeline

• Start date: 2024-02-26
• Primary completion: 2026-06-01
• Completion: 2027-08-01
• First posted: 2024-02-02
• Last updated: 2025-09-09

Locations

34 sites across 6 countries: United States, Belgium, France, Italy, South Korea, Spain

Regulatory

• FDA-regulated drug study