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

NCT05300048 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 34

Last updated 2026-04-30

No results posted yet for this study

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.

Conditions

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

Interventions

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

DRUG

Serabelisib

serabelisib administered orally

Sponsors & Collaborators

  • Faeth Therapeutics

    lead INDUSTRY

Principal Investigators

  • Vicky Makker · Memorial Sloan Kettering Cancer Center

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-04-22
Primary Completion
2025-04-30
Completion
2025-04-30
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05300048 on ClinicalTrials.gov