Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 12:53 AM
Ignite Modification Date:
2025-12-25 @ 12:53 AM
NCT ID:
NCT06239467
Eligibility Criteria:
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 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.
Additional Cohort-specific key inclusion criteria:
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.
Key Exclusion Criteria:
* Treatment with any investigational product or other anticancer therapy within 28 days or 5 half-lives, whichever is shorter, of the start of treatment
* Participants with a known KRAS mutation.
* Participants with a known deleterious mutation in phosphatase and tensin homolog (PTEN) or negative for PTEN protein expression by IHC.
* Major surgery or wide-field radiation within 28 days or limited field palliative radiation within 7 days prior to the first dose of study drug.
* Known active central nervous system metastasis, including leptomeningeal disease.
* Uncontrolled Type 1 or Type 2 diabetes as defined by HbA1C ≥ 8%.
* Concomitant active malignancy or previous malignancy within 2 years of the time of enrollment.
* Impaired cardiovascular function or clinically significant cardiovascular disease,
* History of symptomatic drug-induced pneumonitis.
* Participants with active HIV, Hepatitis B, and Hepatitis C viral infections
Additional Cohort-specific key exclusion criteria:
Part C:
* Grade 2 or higher diarrhea at study entry.
* History of chronic liver disease.
Part E:
● History of interstitial lung disease.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06239467
Study Brief:
Protocol Section:
NCT06239467