Advanced CancerPhase 1PIKture-01NCT06239467
First-in-Human Study of OKI-219 in Advanced Solid Tumors and Advanced Breast Cancer
A Phase 1 study testing OKI-219, Fulvestrant and Trastuzumab in people with Advanced Cancer and Breast Cancer, run by OnKure, Inc. at 33 sites in 6 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Cancer, Breast Cancer, Advanced Solid Tumors
- What is being tested?
- OKI-219, Fulvestrant and Trastuzumab
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 33 sitesin 6 countries
- Study dates
- 26 Feb 2024to 1 Aug 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 Parts B, C, D, and E in the opinion of the Investigator.
- Adequate organ and bone marrow function
- Have adequate archival tumor tissue sample available or be approved by the Sponsor for enrollment if no tumor sample is available.
- At least 1 measurable lesion based on RECIST version 1.1.
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- Additional Cohort-specific key inclusion criteria:
- Part A
- Participants with HR+/HER2- locally advanced, unresectable or metastatic breast cancer, must have received at least 1 prior line of hormonal therapy and at least 1 prior line of CDK4/6-inhibitor in the advanced or metastatic setting.
- Participants with HER2+ locally advanced, unresectable or metastatic breast cancer, must have received prior taxane, trastuzumab, pertuzumab, and tucatinib. Prior trastuzumab deruxtecan is allowed but not required.
- Participants with HER2-low breast cancer must have received prior trastuzumab deruxtecan.
- Participants with colorectal cancer must have KRAS wild-type disease.
- Part B
- Participants with locally advanced, unresectable or metastatic HR+/HER2- breast cancer must have received at least 1 prior line of hormonal therapy in the advanced or metastatic setting and at least 1 prior CDK4/6-inhibitor.
- Participants with HER2-low breast cancer should have received prior trastuzumab deruxtecan
- Part C ● Participants with HR±/HER2+ locally advanced, unresectable or metastatic breast cancer must have received prior taxane, trastuzumab, and pertuzumab unless unavailable in the region or contraindicated. Prior trastuzumab deruxtecan is allowed but not required.
- Part D
- ● Participants must have HR+/HER2- locally advanced, unresectable or metastatic breast cancer
- Part E ● Participants must have HR+/HER2- locally advanced, unresectable or metastatic breast cancer.
Who cannot join
- Treatment with any investigational product or other anticancer therapy within 28 days or 5 half-lives, whichever is shorter, of the start of treatment
- Participants with a known KRAS mutation.
- Participants with a known deleterious mutation in phosphatase and tensin homolog (PTEN) or negative for PTEN protein expression by IHC.
- Major surgery or wide-field radiation within 28 days or limited field palliative radiation within 7 days prior to the first dose of study drug.
- Known active central nervous system metastasis, including leptomeningeal disease.
- Uncontrolled Type 1 or Type 2 diabetes as defined by HbA1C ≥ 8%.
Show all 16Show fewer
- Concomitant active malignancy or previous malignancy within 2 years of the time of enrollment.
- Impaired cardiovascular function or clinically significant cardiovascular disease,
- History of symptomatic drug-induced pneumonitis.
- Participants with active HIV, Hepatitis B, and Hepatitis C viral infections
- Additional Cohort-specific key exclusion criteria:
- Part C:
- Grade 2 or higher diarrhea at study entry.
- History of chronic liver disease.
- Part E:
- ● History of interstitial lung disease.
Trial locations and contacts
33 sites in 6 countries.
33 sites in 6 countries
United States12 sites
Regents of the University of Colorado
Aurora, Colorado, 80045
Massachusetts General Hospital
Boston, Massachusetts, 02114
Sarah Cannon Research Institute at HealthONE
Denver, Colorado, 80218
California Cancer Associates for Research and Excellence
Encinitas, California, 92024
NEXT Oncology Virginia
Fairfax, Virginia, 22031
University of California San Diego UCSD
La Jolla, California, 92093
Comprehensive Cancer Centers of Nevada
Las Vegas, Nevada, 89169
UCLA Jonsson Comprehensive Cancer Center
Los Angeles, California, 90024
SCRI Oncology Partners - Nashville
Nashville, Tennessee, 37203
Hoag - Huntington Beach
Newport Beach, California, 92663
Fred Hutchinson Cancer Center
Seattle, Washington, 98109
Stony Brook University
Stony Brook, New York, 11794
France6 sites
Centre de Lutte Contre le Cancer CLCC - Centre Georges Francois Leclerc (CGFL)
Dijon, 21079
Centre Oscar Lambret
Lille, 59020
Centre Leon Berard
Lyon, 69008
Centre Antoine Lacassagne
Nice, 06189
Hopital Lyon Sud
Pierre-Bénite, 69310
Institut Gustave Roussy
Villejuif, 94805
South Korea5 sites
Gachon University Gil Medical Center
Incheon, 21565
Seoul National University Hospital
Seoul, 03080
Severance Hospital
Seoul, 03722
Asan Medical Center
Seoul, 05505
Samsung Medical Center
Seoul, 06351
Spain4 sites
NEXT Oncology Phase I Unit / IOB- Hospital Quironsalud Barcelona
Barcelona, 08023
Hospital Beata Maria Ana
Madrid, 28007
Hospital Universitario 12 de Octubre
Madrid, 28041
START - Madrid
Madrid, 28050
Belgium3 sites
Institut Jules Bordet
Anderlecht, 1070
UZ Leuven - Campus Gasthuisberg
Leuven, 3000
GZA Hopsitals Campus Sint-Augustinus
Wilrijk, 2610
Italy3 sites
Ospedale San Raffaele
Milan, 20132
Ospedale San Gerardo-ASST Monza
Monza, 20900
Istituto Clinico Humanitas
Rozzano, 20089
About this study
Official title: 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
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.
- Being tested
- OKI-219, Fulvestrant, Trastuzumab, Tucatinib, Atirmociclib
- Keywords
- PI3K, Solid Tumor, Breast Cancer, OKI-219, trastuzumab, fulvestrant, H1047r, ribociclib, atirmociclib, tucatinib
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OKI-219Drug
Oral twice daily
FulvestrantDrug
Intramuscular injection
TrastuzumabDrug
Intravenous (IV)
TucatinibDrug
Oral twice daily
AtirmociclibDrug
Oral twice daily
RibociclibDrug
Oral once daily continuous for 21-days followed by 7 days off
| Study group | Role | What they receive |
|---|---|---|
| Phase 1a: Part A Dose Escalation | Experimental | OKI-219 Monotherapy Dose Escalation in participants with advanced solid tumors with the PI3KαH1047R mutation Receives: Drug: OKI-219 |
| Phase 1b: Part B Dose Escalation | Experimental | OKI-219 + Fulvestrant Dose Escalation in participants with HR+/HER2- locally advanced, unresectable or metastatic breast cancer with the PI3KαH1047R mutation Receives: Drug: OKI-219; Drug: Fulvestrant |
| Phase 1b: Part B Dose Optimization | Experimental | OKI-219 + Fulvestrant Dose Optimization in participants with HR+/HER2- locally advanced, unresectable or metastatic breast cancer with the PI3KαH1047R mutation Receives: Drug: OKI-219; Drug: Fulvestrant |
| Phase 1b: Part C Dose Escalation | Experimental | OKI-219 + Tucatinib + Trastuzumab Dose Escalation in participants with HR±/HER2+ locally advanced, unresectable or metastatic breast cancer with the PI3KαH1047R mutation Receives: Drug: OKI-219; Drug: Trastuzumab; Drug: Tucatinib |
| Phase 1b: Part C Dose Expansion | Experimental | OKI-219 + Tucatinib + Trastuzumab Dose Expansion in participants with HR±/HER2+ locally advanced, unresectable or metastatic breast cancer with the PI3KαH1047R mutation Receives: Drug: OKI-219; Drug: Trastuzumab; Drug: Tucatinib |
| Phase 1b: Part D Dose Escalation | Experimental | OKI-219 + Fulvestrant + Atirmociclib Dose Escalation in participants with HR+/HER2- locally advanced, unresectable or metastatic breast cancer with the PI3KαH1047R mutation Receives: Drug: OKI-219; Drug: Fulvestrant; Drug: Atirmociclib |
| Phase 1b: Part D Dose Expansion | Experimental | OKI-219 + Fulvestrant + Atirmociclib Dose Escalation in participants with HR+/HER2- locally advanced, unresectable or metastatic breast cancer with the PI3KαH1047R mutation Receives: Drug: OKI-219; Drug: Fulvestrant; Drug: Atirmociclib |
| Phase 1b: Part E Dose Escalation | Experimental | OKI-219 + Fulvestrant + Ribociclib Dose Escalation in participants with HR+/HER2- locally advanced, unresectable or metastatic breast cancer with the PI3KαH1047R mutation Receives: Drug: OKI-219; Drug: Fulvestrant; Drug: Ribociclib |
| Phase 1b: Part E Dose Expansion | Experimental | OKI-219 + Fulvestrant + Ribociclib Dose Expansion in participants with HR+/HER2- locally advanced, unresectable or metastatic breast cancer with the PI3KαH1047R mutation Receives: Drug: OKI-219; Drug: Fulvestrant; Drug: Ribociclib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Identify maximum tolerated dose (MTD) of OKI-219 in monotherapy
Frequency of participants experiencing dose-limiting toxicities during the first 28-day cycle
Measured: Cycle 1 (First 28 days on treatment)
Assess safety of OKI-219 as monotherapy or in combination with other anti-cancer therapies: incidence of SAEs
Number and type of SAEs experienced by participants during treatment and follow-up
Measured: Through 30 days after last dose, an average of 1 year
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
Number of treatment-emergent adverse events (TEAEs) equal or greater than Grade 2 experienced during treatment and follow-up
Measured: Through 30 days after last dose, an average of 1 year
Assess rate of dose modifications during treatment with OKI-219 as monotherapy or in combination with other anti-cancer therapies
rate of dose modifications
Measured: Through last study dose, an average of 1 year
Secondary outcomes (10)
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)
PK of OKI-219: Cmax
Measured: 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)
PK of OKI-219: Tmax
Measured: 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)
PK of OKI-219: AUC
Measured: 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: terminal elimination half-life time (t1/2)
PK of OKI-219: t1/2
Measured: Through cycle 6 of treatment (up to 28 weeks)
To estimate the preliminary antitumor activity of OKI-219 as monotherapy and in combination with other anti-cancer therapies: objective response rate (ORR)
ORR per investigator assessed Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST 1.1)
Measured: Up to approximately 36 months
To estimate the preliminary antitumor activity of OKI-219 as monotherapy and in combination with other anti-cancer therapies: clinical benefit rate (CBR)
CBR per investigator assessed Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST 1.1)
Measured: Up to approximately 36 months
Dose optimization only: to estimate the preliminary antitumor activity of OKI-219 as monotherapy and in combination with other anti-cancer therapies: progression free survival (PFS)
PFS per investigator assessed Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST 1.1)
Measured: Up to approximately 36 months
To assess the dose-response impact of OKI-219 as monotherapy and in combination with other anti-cancer therapies on PI3KαH1047R ctDNA levels
Changes in PI3KαH1047R ctDNA on treatment and end of treatment (EOT) compared to baseline.
Measured: Through last study dose, an average of 1 year
To determine the impact of OKI-219 dosing as monotherapy and in combination with other anti-cancer therapies on blood glucose and insulin
Changes in plasma glucose, serum insulin, serum c-peptide levels, and hemoglobin A1c (HbA1c) will be evaluated on treatment compared to baseline.
Measured: Through last study dose, an average of 1 year
To assess the PDx activity of OKI-219 as monotherapy and in combination with other anti-cancer therapies
PDx activity will be evaluated with serial tumor biopsy samples assessed for PI3K/AKT/mTOR downstream pathway changes.
Measured: Through last study dose, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2024
- Study start26 Feb 2024
- Primary completion31 Dec 2026 (estimated)
- Study completion1 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- OnKure, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06239467
- Sponsor's protocol ID
- OKI-219-101
- Acronym
- PIKture-01
- Status last verified
- Jul 2026
- First submitted
- 12 Jan 2024
- Last updated
- 6 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06239467
- Acronym / sponsor ID
- PIKture-01 / OKI-219-101
- Keywords
- PI3K, Solid Tumor, Breast Cancer, OKI-219, trastuzumab, fulvestrant, H1047r, ribociclib
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- OnKure, Inc.Industry (pharma, biotech, devices)
- Study start
- 26 Feb 2024 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 1 Aug 2027 (estimated)
- First posted
- 2 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 9
| Arm | Type | Receives |
|---|---|---|
| Phase 1a: Part A Dose Escalation | Experimental | Drug: OKI-219OKI-219 Monotherapy Dose Escalation in participants with advanced solid tumors with the PI3KαH1047R mutation |
| Phase 1b: Part B Dose Escalation | Experimental | Drug: OKI-219, Drug: FulvestrantOKI-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 Optimization | Experimental | Drug: OKI-219, Drug: FulvestrantOKI-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 Escalation | Experimental | Drug: OKI-219, Drug: Trastuzumab, Drug: TucatinibOKI-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 Expansion | Experimental | Drug: OKI-219, Drug: Trastuzumab, Drug: TucatinibOKI-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 Escalation | Experimental | Drug: OKI-219, Drug: Fulvestrant, Drug: AtirmociclibOKI-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 Expansion | Experimental | Drug: OKI-219, Drug: Fulvestrant, Drug: AtirmociclibOKI-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 Escalation | Experimental | Drug: OKI-219, Drug: Fulvestrant, Drug: RibociclibOKI-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 Expansion | Experimental | Drug: OKI-219, Drug: Fulvestrant, Drug: RibociclibOKI-219 + Fulvestrant + Ribociclib Dose Expansion in participants with HR+/HER2- locally advanced, unresectable or metastatic breast cancer with the PI3KαH1047R mutation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- 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 Parts B, C, D, and E in the opinion of the Investigator.
- Adequate organ and bone marrow function
- Have adequate archival tumor tissue sample available or be approved by the Sponsor for enrollment if no tumor sample is available.
Key exclusion criteria (16 listed)
- Treatment with any investigational product or other anticancer therapy within 28 days or 5 half-lives, whichever is shorter, of the start of treatment
- Participants with a known KRAS mutation.
- Participants with a known deleterious mutation in phosphatase and tensin homolog (PTEN) or negative for PTEN protein expression by IHC.
- Major surgery or wide-field radiation within 28 days or limited field palliative radiation within 7 days prior to the first dose of study drug.
- Known active central nervous system metastasis, including leptomeningeal disease.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OKI-219Oral twice daily | Drug | Phase 1a: Part A Dose Escalation, Phase 1b: Part B Dose Escalation, Phase 1b: Part B Dose Optimization, Phase 1b: Part C Dose Escalation, Phase 1b: Part C Dose Expansion, Phase 1b: Part D Dose Escalation, Phase 1b: Part D Dose Expansion, Phase 1b: Part E Dose Escalation, Phase 1b: Part E Dose Expansion |
| FulvestrantIntramuscular injection | Drug | Phase 1b: Part B Dose Escalation, Phase 1b: Part B Dose Optimization, Phase 1b: Part D Dose Escalation, Phase 1b: Part D Dose Expansion, Phase 1b: Part E Dose Escalation, Phase 1b: Part E Dose Expansion |
| TrastuzumabIntravenous (IV) | Drug | Phase 1b: Part C Dose Escalation, Phase 1b: Part C Dose Expansion |
| TucatinibOral twice daily | Drug | Phase 1b: Part C Dose Escalation, Phase 1b: Part C Dose Expansion |
| AtirmociclibOral twice daily | Drug | Phase 1b: Part D Dose Escalation, Phase 1b: Part D Dose Expansion |
| RibociclibOral once daily continuous for 21-days followed by 7 days off | Drug | Phase 1b: Part E Dose Escalation, Phase 1b: Part E Dose Expansion |
Primary outcome
Identify maximum tolerated dose (MTD) of OKI-219 in monotherapy
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Through last study dose, an average of 1 year
rate of dose modifications
10 secondary outcomes
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)
Time frame: 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)
Time frame: 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)
Time frame: 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: terminal elimination half-life time (t1/2)
Time frame: Through cycle 6 of treatment (up to 28 weeks)
To estimate the preliminary antitumor activity of OKI-219 as monotherapy and in combination with other anti-cancer therapies: objective response rate (ORR)
Time frame: Up to approximately 36 months
To estimate the preliminary antitumor activity of OKI-219 as monotherapy and in combination with other anti-cancer therapies: clinical benefit rate (CBR)
Time frame: Up to approximately 36 months
Dose optimization only: to estimate the preliminary antitumor activity of OKI-219 as monotherapy and in combination with other anti-cancer therapies: progression free survival (PFS)
Time frame: Up to approximately 36 months
To assess the dose-response impact of OKI-219 as monotherapy and in combination with other anti-cancer therapies on PI3KαH1047R ctDNA levels
Time frame: Through last study dose, an average of 1 year
To determine the impact of OKI-219 dosing as monotherapy and in combination with other anti-cancer therapies on blood glucose and insulin
Time frame: Through last study dose, an average of 1 year
To assess the PDx activity of OKI-219 as monotherapy and in combination with other anti-cancer therapies
Time frame: Through last study dose, an average of 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
33 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing OKI-219, Fulvestrant and Trastuzumab in people with Advanced Cancer and Breast Cancer, run by OnKure, Inc. at 33 sites in 6 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 19 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 6 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 33 sites in United States, France, South Korea, Spain, Belgium and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Identify maximum tolerated dose (MTD) of OKI-219 in monotherapy (time frame: Cycle 1 (First 28 days on treatment)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jul 2026.