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...
Top 2 of 4 competitors
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| GE Healthcare Technologies Inc. | GEHC | 1 | PHASE1 | GEH200520/GEH200521 |
| Ascentage Pharma Group International Unsponsored ADR | AAPG | 1 | PHASE1 | Olverembatinib |
OKI-219 is an investigational small molecule developed by OnKure Therapeutics, Inc. for the treatment of advanced cancer. It is being studied in a first-in-human Phase 1 clinical trial in patients with advanced solid tumors and advanced breast cancer, including tumors with PI3K gene mutations.
OKI-219 is being evaluated for the treatment of advanced solid tumors and advanced breast cancer, including cases with PI3K gene mutations. It is an investigational therapy and has not been approved for any indication. The Phase 1 study enrolls adults 18 years and older.
OKI-219 targets PI3K alpha, a lipid kinase encoded by the PIK3CA gene that is classified as an oncogene. PI3K alpha is frequently altered in cancer, and OKI-219 is designed as a small molecule directed at this target. The Phase 1 trial includes patients with PI3K gene mutations.
OKI-219 is being developed by OnKure Therapeutics, Inc., which trades under the ticker OKUR. The company is running the first-in-human Phase 1 study of the drug in advanced solid tumors and advanced breast cancer across sites in the United States, Belgium, France, Italy, South Korea, and Spain.
OKI-219 is in Phase 1 clinical development. It is investigational and has not been approved by the FDA or any other regulatory agency. The single ongoing Phase 1 trial is a first-in-human study that is currently active but not recruiting, with a planned enrollment of 200 patients.
OKI-219 is being studied in one active Phase 1 trial, NCT06239467, titled First-in-Human Study of OKI-219 in Advanced Solid Tumors and Advanced Breast Cancer. The trial is controlled, includes biomarker-selected patients with PI3K gene mutations, and has a planned enrollment of 200 participants.