A Phase 1b Study of Serabelisib in Combination with an Insulin Suppressing Diet With or Without Nab-paclitaxel in Subjects With Advanced Solid Tumors With PIK3CA Mutations (SER-ISD1-001)
While targeted therapies for cancer, such as PI3K (phosphoinositide 3-kinase) inhibitors, can increase progression free survival, they also cause systemic metabolic side effects that result in decreased efficacy, poor quality of life, noncompliance, and discontinuation.
In preclinical models of cancer, the anticancer efficacy and side effect profile of PI3K inhibitors has been dramatically improved by controlling systemic metabolism with a precisely formulated diet that controls systemic insulin levels (insulin suppressing diet / ISD). Serabelisib is a selective small molecule inhibitor of PI3Kα (phosphoinositide 3-kinase alpha isoform).
Preclinical studies have shown that combining PI3Kα inhibition with ISD resulted in improved efficacy and improved metabolic control versus PI3Kα inhibitor alone.
This study will evaluate the feasibility of optimizing the safety and tolerability of Serabelisib when combined with a precision nutrition insulin suppressing diet (ISD) with or without Nab-paclitaxel with the goal of reducing side effects and significantly enhancing anticancer activity.
Cohort 1 (Dose Modification): Adult subjects with any advanced solid tumor with PIK3CA mutations with or without PTEN loss.
Cohorts 2, 3, and 4 (Cohort Expansion): Adult subjects with PIK3CA-mutations with or without PTEN loss, and advanced colorectal cancer, advanced endometrial cancer, or advanced ovarian clear cell or ovarian endometrioid carcinoma.
Learn more on clinicaltrials.gov