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Canagliflozin

Serabelisib

Sodium-Glucose Transporter 2 Inhibitors

Enzyme Inhibitors

Part 1 is dose escalation of Serabelisib Cohort 1 = 600mg; Cohort 2 = 900mg; Cohort 3 = 1200mg

Part 2 is expansion of mutational cohorts with selected dose as follows:

Cohort 4 = PIK3CA-mutated breast cancer; Cohort 5 = PIK3CA-mutated Non breast cancer; Cohort 6 = KRAS mutated

Subjects will be dosed with Serabelisib on 3 consecutive days a week in a 28 day cycle until tumor progression. in combination with Canagliflozin 300mg, both are oral medications

All subjects will be dosed with 300 mg canagliflozin in combination with serabelisib

Canagliflozin 300mg

Albert Yu, MD

Peggy Siemon-Hryczyk, MS

This study aims to test the hypothesis that combining serabelisib, a PI3K alpha isoform inhibitor, with an SGLT2 inhibitor, canagliflozin will improve efficacy in the treatment of patients with advanced solid tumors.

This study aims to test the hypothesis that controlling the glucose/insulin feedback will enhance the efficacy of PI3K inhibition in treating solid tumors. The treatment consists of serabelisib, a PI3K alpha isoform (PI3Kα) inhibitor, combined with the sodium-glucose cotransporter-2 (SGLT2) inhibitor canagliflozin. The study will assess the safety and efficacy of the combination in adult patients with advanced solid tumors harboring mutations that may be dependent on PI3Kα activity: PIK3CA mutations and KRAS mutations.

A Phase 1b/2 Study of Serabelisib in Combination With Canagliflozin in Patients With Advanced Solid Tumors

A Phase 1b/2 Study of Serabelisib in Combination With Canagliflozin in Patients With Advanced Solid Tumors With PIK3CA or KRAS Mutations

Safety of serabelisib in combination with canagliflozin as evaluated by incidence of drug-related adverse events (AEs), serious adverse events (SAEs), adverse events leading to discontinuation, deaths and clinical laboratory test abnormalities.

Safety of serabelisib in combination with canagliflozin as evaluated by incidence of clinical laboratory abnormalities

To confirm the appropriate dose of serabelisib to be coadministered with canagliflozin

To assess efficacy of serabelisib in combination with canagliflozin in patients with solid tumors with PIK3CA or KRAS mutations

Maximum observed plasma concentration (Cmax) of serabelisib

Time of maximum observed plasma concentration (Tmax) of serabelisib

Area under the plasma concentration time curve in the dosing interval AUC of serabelisib

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
A Phase 1b/2 Study of Serabelisib in Combination With Canagliflozin in Patients With Advanced Solid Tumors	NCT04073680	Breast Cancer Endometrial Can... Lung Cancer Colo-rectal Can... Head and Neck C...	Serabelisib Canagliflozin 3...	18 Years -	Petra Pharma
A Phase 1b/2 Study of Serabelisib in Combination With Canagliflozin in Patients With Advanced Solid Tumors	NCT04073680	Breast Cancer Endometrial Can... Lung Cancer Colo-rectal Can... Head and Neck C...	Serabelisib Canagliflozin 3...	18 Years -	Petra Pharma
A Phase 1b/2 Study of Serabelisib in Combination With Canagliflozin in Patients With Advanced Solid Tumors	NCT04073680	Breast Cancer Endometrial Can... Lung Cancer Colo-rectal Can... Head and Neck C...	Serabelisib Canagliflozin 3...	18 Years -	Petra Pharma

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