NCT05300048

Combination of Serabelisib and Insulin Suppressing Diet With or Without Nab-paclitaxel in Subjects With Advanced Solid Tumors With PIK3CA Mutations

A Phase 1b Study of Serabelisib in Combination With an Insulin Suppressing Diet (Study ISD) and With or Without Nab-paclitaxel in Adult Subjects With Advanced Solid Tumors With PIK3CA Mutations With or Without PTEN Loss

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 34 (actual)
• Sponsor: Faeth Therapeutics · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study will evaluate the feasibility of optimizing the safety and tolerability of serabelisib (an investigational PI3K inhibitor) when combined with an ISD and with or without nab-paclitaxel with a goal of reducing side effects and enhancing anticancer activity.

Detailed description

Targeted anticancer drugs have side effects that often result in a poor quality of life, noncompliance, dose decreases, or discontinuation, all of which can affect efficacy. This study will evaluate the feasibility of optimizing the safety and tolerability of serabelisib when combined with an insulin suppressing diet and with or without nab-paclitaxel with a goal of reducing side effects and enhancing anticancer activity.

Conditions

• Advanced Solid Tumor
• PIK3CA Mutation
• PTEN Loss of Function Mutation

Interventions

Type	Name	Description
DRUG	Serabelisib	serabelisib administered orally
OTHER	Insulin Suppressing Diet	3 meals consumed daily (i.e., breakfast, lunch, dinner) and optional snacks provided dependent on caloric needs
DRUG	Nab paclitaxel	nab-paclitaxel administered intravenously weekly

Timeline

• Start date: 2022-04-22
• Primary completion: 2025-04-30
• Completion: 2025-04-30
• First posted: 2022-03-29
• Last updated: 2025-10-06

Locations

17 sites across 1 country: United States

Regulatory

• FDA-regulated drug study