First-in-Human Study of OKI-219 in Advanced Solid Tumors and Advanced Breast Cancer

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 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.
• •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.