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OKI-219

Phase 1

Advanced Cancer | Small molecule | Oncology |OnKure Therapeutics, Inc.|Last Updated: Sep 9, 2025

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedCONTROLLEDBiomarker
Total Trials1
Total Enrollment200
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT06239467First-in-Human Study of OKI-219 in Advanced Solid Tumors and Advanced Breast CancerPHASE1 RECRUITING 200 — — Feb 26, 2024Aug 1, 2027Sep 9, 202534 United States, Belgium +4
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Study Endpoints
Primary Endpoints
Identify maximum tolerated dose (MTD) of OKI-219 in monotherapy
Cycle 1 (First 28 days on treatment)

Frequency of participants experiencing dose-limiting toxicities during the first 28-day cycle

Assess safety of OKI-219 as monotherapy or in combination with other anti-cancer therapies: incidence of SAEs
Through 30 days after last dose, an average of 1 year

Number and type of SAEs experienced by participants during treatment and follow-up

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
Through 30 days after last dose, an average of 1 year

Number of treatment-emergent adverse events (TEAEs) equal or greater than Grade 2 experienced during treatment and follow-up

Assess rate of dose modifications during treatment with OKI-219 as monotherapy or in combination with other anti-cancer therapies
Through last study dose, an average of 1 year

rate of dose modifications

Secondary Endpoints
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)
Through cycle 6 of treatment (up to 28 weeks)
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)
Through cycle 6 of treatment (up to 28 weeks)
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)
Through cycle 6 of treatment (up to 28 weeks)
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelSEQUENTIAL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Phase 1a: Part A Dose EscalationEXPERIMENTALOKI-219 Monotherapy Dose Escalation in participants with advanced solid tumors with the PI3KαH1047R mutation
Phase 1b: Part B Dose EscalationEXPERIMENTALOKI-219 + Fulvestrant Dose Escalation in participants with HR+/HER2- locally advanced, unresectable or metastatic breast cancer with the PI3KαH1047R mutation
Phase 1b: Part B Dose OptimizationEXPERIMENTALOKI-219 + Fulvestrant Dose Optimization in participants with HR+/HER2- locally advanced, unresectable or metastatic breast cancer with the PI3KαH1047R mutation
Phase 1b: Part C Dose EscalationEXPERIMENTALOKI-219 + Tucatinib + Trastuzumab Dose Escalation in participants with HR±/HER2+ locally advanced, unresectable or metastatic breast cancer with the PI3KαH1047R mutation
Phase 1b: Part C Dose ExpansionEXPERIMENTALOKI-219 + Tucatinib + Trastuzumab Dose Expansion in participants with HR±/HER2+ locally advanced, unresectable or metastatic breast cancer with the PI3KαH1047R mutation
Phase 1b: Part D Dose EscalationEXPERIMENTALOKI-219 + Fulvestrant + Atirmociclib Dose Escalation in participants with HR+/HER2- locally advanced, unresectable or metastatic breast cancer with the PI3KαH1047R mutation
Phase 1b: Part D Dose ExpansionEXPERIMENTALOKI-219 + Fulvestrant + Atirmociclib Dose Escalation in participants with HR+/HER2- locally advanced, unresectable or metastatic breast cancer with the PI3KαH1047R mutation
Phase 1b: Part E Dose EscalationEXPERIMENTALOKI-219 + Fulvestrant + Ribociclib Dose Escalation in participants with HR+/HER2- locally advanced, unresectable or metastatic breast cancer with the PI3KαH1047R mutation
Phase 1b: Part E Dose ExpansionEXPERIMENTALOKI-219 + Fulvestrant + Ribociclib Dose Expansion in participants with HR+/HER2- locally advanced, unresectable or metastatic breast cancer with the PI3KαH1047R mutation
Interventions
NameTypeDescription
OKI-219DRUGOral twice daily
FulvestrantDRUGIntramuscular injection
TrastuzumabDRUGIntravenous (IV)
TucatinibDRUGOral twice daily
AtirmociclibDRUGOral twice daily
RibociclibDRUGOral once daily continuous for 21-days followed by 7 days off
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites34

Key Inclusion Criteria: * Participants with advanced solid tumors with documented evidence of a PI3KαH1047R mutation in tumor tissue and/or blood (ie, ctDNA). * Eastern Cooperative Oncology Group (ECOG) Performance status score of to 1. * Life expectancy \> 12 weeks for Part A and \> 6 months for P...

Countries:United StatesBelgiumFranceItalySouth KoreaSpain
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Competitive Landscape -Cancer 5 trials
CompanyTickerTrialsLead PhaseDrugs
GE Healthcare Technologies Inc.GEHC1PHASE1GEH200520 / GEH200521 - Part A
Zimmer Biomet Holdings, Inc.ZBH1 — Undisclosed
Ascentage Pharma Group International Unsponsored ADRAAPG1PHASE1Olverembatinib
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Recent Changes (Last 90 Days)
LOWMay 26, 2026NCT06239467primaryCompletionDate: changed
LOWMay 24, 2026NCT06239467studyFirstPostDate: changed