OnKure stops enrolling PIKture-01 and pushes OKI-219 completion to December 2026
The PI3Kα inhibitor trial closed enrollment at 200 patients and slid its primary completion date by seven months, as OnKure holds to a year-end 2026 data readout.
Executive Summary
- OnKure closed enrollment in PIKture-01 (NCT06239467), moving the trial to Active, not recruiting, and simultaneously pushed the primary completion date from June 1, 2026 to December 31, 2026, a seven-month extension disclosed the same day.
- Enrollment closed at 200 patients, the target OnKure raised from 150 in September 2025, meaning the trial reached its expanded goal even as the completion clock moved back.
- The completion-date slip lands the readout at the far edge of the year-end 2026 window OnKure has publicly guided to, tightening the runway between trial completion and the disclosure investors are expecting.
- Inavolisib, the direct same-target PI3Kα comparator from Hoffmann-La Roche, is already in Phase 3 for breast cancer, so OKI-219's Phase 1 timeline continues to trail the most advanced asset in its mechanism class.
- No endpoint data beyond a December 2024 Part A tolerability update has been disclosed, so the trial's actual safety and activity profile remains unverified ahead of the guided readout.
The registry update
ClinicalTrials.gov recorded two changes to NCT06239467 on July 6, 2026: the trial status moved from Recruiting to Active, not recruiting, and the primary completion date moved from June 1, 2026 to December 31, 2026 NCT06239467First-in-Human Study of OKI-219 in Advanced Solid Tumors and Advanced Breast CancerNCT06239467. The two changes arrived together, which typically signals that enrollment has finished and the sponsor has reset its internal timeline for when the last patient will complete the primary assessment window.
Probability of SuccessBased on the AppliedXL Probability of Success model. For more information about the methodology, read the research here.
Enrollment context
The trial's enrollment target itself moved earlier: OnKure raised the anticipated enrollment from 150 to 200 patients on September 9, 2025. The July 2026 status change confirms enrollment closed at that expanded figure of 200 NCT06239467First-in-Human Study of OKI-219 in Advanced Solid Tumors and Advanced Breast CancerNCT06239467. PIKture-01 is a five-part Phase 1a/1b study, testing OKI-219 as monotherapy in Part A and in four combination regimens, including with fulvestrant, trastuzumab plus tucatinib, atirmociclib, and ribociclib plus fulvestrant, across breast cancer and other PI3KαH1047R-mutant tumors NCT06239467First-in-Human Study of OKI-219 in Advanced Solid Tumors and Advanced Breast CancerNCT06239467.
What the endpoints measure
The trial's four registered primary endpoints are all safety or operational measures: incidence of serious adverse events, maximum tolerated dose determined by dose-limiting toxicities in the first 28-day cycle, incidence of Grade 2 or greater treatment-emergent adverse events, and the rate of dose modifications during treatment NCT06239467First-in-Human Study of OKI-219 in Advanced Solid Tumors and Advanced Breast CancerNCT06239467. Objective response rate, clinical benefit rate, and progression-free survival are listed as secondary endpoints, evaluated by RECIST 1.1 NCT06239467First-in-Human Study of OKI-219 in Advanced Solid Tumors and Advanced Breast CancerNCT06239467. The 20.0% endpoint-met probability the model assigns therefore reflects the likelihood the safety and PK bar clears, not a read on whether OKI-219 shrinks tumors.
What's already known
OnKure disclosed preliminary Part A monotherapy data in December 2024, describing OKI-219 as generally well tolerated across dose levels, with no dose-limiting toxicities in completed cohorts and only Grade 1 treatment-related adverse events, alongside pharmacokinetic data the company said supported continued dose escalation. No results have since been posted to ClinicalTrials.gov, and the company has said only that it plans to report PIKture-01 data by the end of 2026.
Protocol stability
The trial carries a Moderate protocol stability rating, with 2.44 registry change events per year, split between one enrollment-count change and one primary-completion-date change. That is a proxy metric based on registry events rather than confirmed protocol amendments, but it places PIKture-01 in a middle tier: not a program in visible distress, but one that has moved both its enrollment target and its completion timeline since 2024.
Competitive position
OKI-219 is not first-in-class; four other trials are actively studying PI3Kα in tumors. Inavolisib, developed by Hoffmann-La Roche, shares an identical target and modality and has already advanced to Phase 3 in breast cancer (NCT06790693), making it the nearest direct comparator. Divarasib, also from Hoffmann-La Roche, is a same-target Phase 1 asset in colorectal cancer. Relay Therapeutics' RLY-2608 and Eli Lilly's STX-478 (tersolisib) are the closest same-mechanism Phase 1/2 peers still in early development alongside OKI-219.
Sponsor track record
OnKure has completed 5 of 7 prior trials, a 71% completion rate, with 2 terminations recorded across its portfolio of 8 trials. That history does not point to a pattern of program failure, but it also does not clear the operational-execution question the completion-date slip raises for this specific study.
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.