Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
OKI-219 · 1 trial · 4 indications
Frequency of participants experiencing dose-limiting toxicities during the first 28-day cycle
Number and type of SAEs experienced by participants during treatment and follow-up
Number of treatment-emergent adverse events (TEAEs) equal or greater than Grade 2 experienced during treatment and follow-up
rate of dose modifications
| Arm | Type | Description |
|---|---|---|
| Phase 1a: Part A Dose Escalation | EXPERIMENTAL | OKI-219 Monotherapy Dose Escalation in participants with advanced solid tumors with the PI3KαH1047R mutation |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| Name | Type | Description |
|---|---|---|
| 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 |
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...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| GE Healthcare Technologies Inc. | GEHC | 1 | PHASE1 | GEH200520/ GEH200521- Part A |
| Zimmer Biomet Holdings, Inc. | ZBH | 1 | - | Undisclosed |
| Ascentage Pharma Group International Unsponsored ADR | AAPG | 1 | PHASE1 | Olverembatinib |
OKI-219 is an investigational small molecule being developed for the treatment of advanced cancer, including advanced solid tumors and advanced breast cancer. It is currently in Phase 1 clinical development for these indications.
OKI-219 targets PI3Kα, an oncogene involved in cancer cell growth and survival. By inhibiting this molecular target, the drug aims to interfere with cancer cell signaling pathways.
OKI-219 is being developed by OnKure Therapeutics, Inc., a biopharmaceutical company traded on the stock exchange under the ticker symbol OKUR.
OKI-219 is currently in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities for commercial use.
OKI-219 is being studied in a first-in-human Phase 1 trial (NCT06239467) for advanced solid tumors and advanced breast cancer. The trial is active but not recruiting, with an enrollment target of 200 participants across the United States, Belgium, France, Italy, South Korea, and Spain.
No alternative names for OKI-219 have been reported. It is identified solely by its drug name, OKI-219, in clinical development.