OnKure pushes OKI-219 first-in-human readout to end of 2026 as enrollment closes
The PI3K-alpha inhibitor's completion date slipped seven months to December 31, 2026, right as the trial stopped recruiting at 200 patients, with no efficacy data yet disclosed.
Executive Summary
- OnKure moved the PIKture-01 primary completion date for OKI-219 seven months, from June 1, 2026 to December 31, 2026, the same disclosure that closed enrollment at 200 patients Press Release+1Press ReleaseJul 6, 2026First-in-Human Study of OKI-219 in Advanced Solid Tumors and Advanced Breast CancerNCT06239467. This resets when the first cross-cohort dataset can post.
- No results are posted on ClinicalTrials.gov and the primary endpoints are all safety measures, not tumor response. Investors have no efficacy signal to evaluate yet, only a December 2024 preliminary tolerability update on the monotherapy arm.
- Roche's inavolisib, a Phase 3 PI3K-alpha inhibitor in breast cancer, is already the direct comparator OKI-219 will eventually face, while Relay Therapeutics and Eli Lilly run competing Phase 1/2 PI3K-alpha assets in overlapping tumor types. OnKure's asset remains behind on stage of development.
- OKI-219 is OnKure's only active trial against a portfolio of 7 prior studies, 5 completed and 2 terminated. A single-asset company has limited room to absorb further timeline slippage.
The registry change
ClinicalTrials.gov records show OnKure changed the primary completion date for PIKture-01 (NCT06239467) from June 1, 2026 to December 31, 2026 on July 6, 2026, the same update that shifted trial status from Recruiting to Active, not recruiting Press Release+1Press ReleaseJul 6, 2026First-in-Human Study of OKI-219 in Advanced Solid Tumors and Advanced Breast CancerNCT06239467. The trial has run since February 26, 2024, and now spans the United States, France, South Korea, Spain, Belgium, and Italy. The completion-date shift moves the earliest expected readout window back by roughly seven months from the prior guidance.
Probability of SuccessBased on the AppliedXL Probability of Success model. For more information about the methodology, read the research here.
What the trial tests
PIKture-01 is a Phase 1a/1b, open-label, multicenter dose-escalation study of OKI-219, a PI3K-alpha H1047R mutant-selective inhibitor, as monotherapy and paired with fulvestrant, trastuzumab and tucatinib, atirmociclib, or ribociclib in advanced tumors and breast cancer. All four primary endpoints measure safety: incidence of Grade 2 or greater treatment-emergent adverse events, incidence of serious adverse events, rate of dose modifications, and maximum tolerated dose via first-cycle dose-limiting toxicities. None of the primary endpoints assess tumor response, so this design cannot by itself establish efficacy; objective response rate and progression-free survival sit among the ten secondary endpoints.
Enrollment expanded, not shrank
The enrollment target grew from 150 to 200 patients on September 9, 2025, when OnKure added two new combination arms, Part D with atirmociclib and Part E with ribociclib and fulvestrant. That expansion, not a shortfall, is the more plausible driver of a longer completion timeline: more cohorts and more combination regimens require more patients and more follow-up before the full dataset can lock. OnKure has told investors it still plans to report PIKture-01 data by the end of 2026.
No efficacy data yet
No results are posted on ClinicalTrials.gov for any endpoint. The only public clinical update is a December 2024 disclosure describing OKI-219 as generally well tolerated in the Part A monotherapy dose-escalation cohorts, with no dose-limiting toxicities and only Grade 1 treatment-related adverse events reported, alongside preliminary pharmacokinetic data. That is a tolerability signal from a small, uncontrolled, single-arm cohort. It is hypothesis-generating and does not establish whether OKI-219 produces tumor responses of any size.
Where OKI-219 sits competitively
Roche's inavolisib, an identical-target, identical-modality PI3K-alpha inhibitor, has already reached Phase 3 in breast cancer and stands as the direct comparator OKI-219 will eventually be measured against. Relay Therapeutics' RLY-2608 and Eli Lilly's STX-478 are earlier-stage PI3K-alpha programs running in overlapping tumor and breast cancer settings; both carry elevated to critical registry risk signals in the broader landscape pull, underscoring that operational volatility is common across this target class, not unique to OnKure. Across the PI3K-alpha target and indication pair, four active trials from five sponsors have yet to push past Phase 1, and the field has not logged a documented success or failure at this phase.
Sponsor concentration
OKI-219 is OnKure's sole active clinical asset. The company has run eight trials historically: five completed, two terminated, and this one active, for a 71% completion rate. Protocol stability on NCT06239467 is rated Moderate, with 2.44 registry change events per year split between the enrollment increase and the completion-date shift, a level of churn that is not alarming on its own but leaves no margin if the December 2026 guidance slips again.
This analysis was produced using AI-assisted reporting systems, AppliedXL data, and official public records. These systems undergo editorial review, quality checks, and regular audits by human experts. Errors may still occur, as with any automated system. Always consult the linked primary sources. Read our AI Editorial Policy.