NCT07522697

Inavolisib for PIK3CA Mutated Advanced Endometrial Cancer: MITO END-4

Inavolisib for PIK3CA Mutated Advanced Endometrial Cancer: a Multicentric, Phase II, MITO END-4 Trial

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 48 (estimated)
• Sponsor: National Cancer Institute, Naples · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

MITO END-4 is a prospective, single arm, multicentric phase II trial aiming to assess whether Inavolisib is effective in the treatment of advanced endometrial carcinoma with pathogenic PIK3CA mutation. Approximately 48 patients with PIK3CA mutation will be overall enrolled in the study.

Detailed description

The PTEN-PI3K-AKT pathway is frequently altered in gynecological tumors, notably in endometrial cancer (EC). Inavolisib is a highly potent and selective PI3K inhibitor that also facilitates the degradation of mutated PI3Kα isoform. The aim of the current trial is to test if inavolisib in PIK3CA mutated endometrial cancer is active enough to merit further future investigations. Patients whose tumors harbor a pathogenic PIK3CA mutation will receive single agent therapy with Inavolisib. Inavolisib will be given orally at a dosage of 9 mg once daily for each day of a 28-day cycle until disease progression or unacceptable toxicity. Approximately 48 patients with PIK3CA mutation will be overall enrolled in the study. Primary Endpoint is the Objective response rate (ORR) defined as a complete response (CR) or partial response (PR) by the Investigator using RECIST 1.1 criteria on the whole treatment period. Secondary objectives are: -description of 6 months progression-free survival (PFS), Description of disease-control rate (DCR), Description of duration of response (DoR), Description of response rate in patients with different PIK3CA mutations, Description of response rate in patients with PIK3CA mutations and PTEN intact, Description of 1 year overall survival (OS), Description of response rate to inavolisib with respect to the PTEN molecular status including LOF in order to assess its potential predictive role of response, to evaluate the safety of inavolisib in the overall study population. Explorative objectives: To evaluate the response to inavolisib in correlation with molecular characteristics of the tumour evaluated on the tissue samples and to follow the identified mutations in the blood during therapy.

Conditions

• Endometrial Cancer

Interventions

Type	Name	Description
DRUG	Inavolisib	The planned starting dose for inavolisib will be 9 mg PO QD taken on Days 1-28 of each 28-day cycle. Dosing will continue until disease progression, unacceptable toxicity, or death. Specifically, the recommended starting dosage of inavolisib for patients with moderate renal impairment (CrCL 30 to \<60 mL/min) is 6 mg orally once daily.

Timeline

• Start date: 2026-05-01
• Primary completion: 2030-05-01
• Completion: 2030-05-01
• First posted: 2026-04-13
• Last updated: 2026-04-13

Locations

1 site across 1 country: Italy