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

Part of paid clinical trials in Encinitas, California.

Sponsor
OnKure, Inc.
Study ID
NCT06239467
Phase
PHASE1
Status
Recruiting
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Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Feb 26, 2024
Status verified
Sep 2025
Primary completion
Jun 1, 2026
Completion
Aug 1, 2027

Study Design

Enrollment
200 participants (estimated)
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Phase 1a: Part A Dose Escalation
    OKI-219 Monotherapy Dose Escalation in participants with advanced solid tumors with the PI3KαH1047R mutation
  • Experimental: Phase 1b: Part B Dose Escalation
    OKI-219 + Fulvestrant Dose Escalation in participants with HR+/HER2- locally advanced, unresectable or metastatic breast cancer with the PI3KαH1047R mutation
  • Experimental: Phase 1b: Part B Dose Optimization
    OKI-219 + Fulvestrant Dose Optimization in participants with HR+/HER2- locally advanced, unresectable or metastatic breast cancer with the PI3KαH1047R mutation
  • Experimental: Phase 1b: Part C Dose Escalation
    OKI-219 + Tucatinib + Trastuzumab Dose Escalation in participants with HR±/HER2+ locally advanced, unresectable or metastatic breast cancer with the PI3KαH1047R mutation
  • Experimental: Phase 1b: Part C Dose Expansion
    OKI-219 + Tucatinib + Trastuzumab Dose Expansion in participants with HR±/HER2+ locally advanced, unresectable or metastatic breast cancer with the PI3KαH1047R mutation
  • Experimental: Phase 1b: Part D Dose Escalation
    OKI-219 + Fulvestrant + Atirmociclib Dose Escalation in participants with HR+/HER2- locally advanced, unresectable or metastatic breast cancer with the PI3KαH1047R mutation
  • Experimental: Phase 1b: Part D Dose Expansion
    OKI-219 + Fulvestrant + Atirmociclib Dose Escalation in participants with HR+/HER2- locally advanced, unresectable or metastatic breast cancer with the PI3KαH1047R mutation
  • Experimental: Phase 1b: Part E Dose Escalation
    OKI-219 + Fulvestrant + Ribociclib Dose Escalation in participants with HR+/HER2- locally advanced, unresectable or metastatic breast cancer with the PI3KαH1047R mutation
  • Experimental: Phase 1b: Part E Dose Expansion
    OKI-219 + Fulvestrant + Ribociclib Dose Expansion in participants with HR+/HER2- locally advanced, unresectable or metastatic breast cancer with the PI3KαH1047R mutation

Primary Outcome Measure

Identify maximum tolerated dose (MTD) of OKI-219 in monotherapy [ Time Frame: Cycle 1 (First 28 days on treatment) ]

Central Contacts

Locations (13)

FacilityCityStateZIPSite coordinators
California Cancer Associates for Research and ExcellenceEncinitasCalifornia92024
Dante Pasiliao
[email protected]
University of California San Diego UCSDLa JollaCalifornia92093
Jasmine Fernandez
[email protected]
UCLA Jonsson Comprehensive Cancer CenterLos AngelesCalifornia90024
Doris Quintanilla
[email protected]
Hoag - Huntington BeachNewport BeachCalifornia92663
Abigail Lazo
[email protected]
Regents of the University of ColoradoAuroraColorado80045
Sarah Cannon Research Institute at HealthONEDenverColorado80218
Jessica Ellis
[email protected]
Massachusetts General HospitalBostonMassachusetts02114
Jennifer Petersen
[email protected]
Karmanos Cancer InsituteDetroitMichigan48201-
Comprehensive Cancer Centers of NevadaLas VegasNevada89169
Elizabeth Hutchings
[email protected]
Stony Brook UniversityStony BrookNew York11794
Pushpa Talanki
[email protected]
SCRI Oncology Partners - NashvilleNashvilleTennessee37203
Gretchen Johnston
[email protected]
NEXT Oncology VirginiaFairfaxVirginia22031
Blake Patterson
[email protected]
Fred Hutchinson Cancer CenterSeattleWashington98109
Kaysey Hermens
[email protected]

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California Cancer Associates for Research and Excellence· Encinitas, CAUniversity of California San Diego UCSD· La Jolla, CAUCLA Jonsson Comprehensive Cancer Center· Los Angeles, CAHoag - Huntington Beach· Newport Beach, CARegents of the University of Colorado· Aurora, COSarah Cannon Research Institute at HealthONE· Denver, CO

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