NCT05300048

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

Completed Phase 1 Last updated 6 October 2025

What this trial tests

Phase 1 trial testing Serabelisib in Advanced Solid Tumor in 34 participants. Completed in 30 April 2025.

Timeline

22 April 2022

Primary endpoint
30 April 2025

30 April 2025

Quick facts

Lead sponsor	Faeth Therapeutics
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	34
Start date	22 April 2022
Primary completion	30 April 2025
Estimated completion	30 April 2025
Sites	17 locations across United States

Drugs / interventions tested

• Serabelisib — full drug profile →
• Insulin Suppressing Diet
• Nab paclitaxel

Conditions studied

• Advanced Solid Tumor — all drugs for Advanced Solid Tumor →
• PIK3CA Mutation — all drugs for PIK3CA Mutation →
• PTEN Loss of Function Mutation — all drugs for PTEN Loss of Function Mutation →

Sponsor

Faeth Therapeutics

Who can join

18 and older, any sex, with Advanced Solid Tumor or PIK3CA Mutation. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

7 peer-reviewed publications reference this trial (live from Europe PMC):

1. PI3K/Akt/mTOR Signaling Pathway as a Target for Colorectal Cancer Treatment.
   Leiphrakpam PD, Are C. · · 2024 · cited 105× · PMID 38542151 · DOI 10.3390/ijms25063178
2. Immunometabolism in cancer: basic mechanisms and new targeting strategy.
   Su R, Shao Y, Huang M, Liu D, et al · · 2024 · cited 28× · PMID 38755125 · DOI 10.1038/s41420-024-02006-2
3. Molecular Targeting of the Phosphoinositide-3-Protein Kinase (PI3K) Pathway across Various Cancers.
   Shan KS, Bonano-Rios A, Theik NWY, Hussein A, et al · · 2024 · cited 19× · PMID 38396649 · DOI 10.3390/ijms25041973
4. Exploring Predictive and Prognostic Biomarkers in Colorectal Cancer: A Comprehensive Review.
   Ashouri K, Wong A, Mittal P, Torres-Gonzalez L, et al · · 2024 · cited 14× · PMID 39199569 · DOI 10.3390/cancers16162796
5. Reprogramming neuroblastoma by diet-enhanced polyamine depletion.
   Cherkaoui S, Turn CS, Yuan Y, Lu W, et al · · 2025 · cited 11× · PMID 40993392 · DOI 10.1038/s41586-025-09564-0
6. Combination Therapy Approach to Overcome the Resistance to PI3K Pathway Inhibitors in Gynecological Cancers.
   Ibanez KR, Huang TT, Lee JM. · · 2024 · cited 10× · PMID 38920692 · DOI 10.3390/cells13121064
7. Molecular Basis of Oncogenic PI3K Proteins.
   Sheng Z, Beck P, Gabby M, Habte-Mariam S, et al · · 2024 · cited 1× · PMID 39796708 · DOI 10.3390/cancers17010077