NCT06496568

A Study Evaluating Single-agent Inavolisib, Inavolisib Plus Atezolizumab, and Inavolisib Plus Pembrolizumab in PIK3CA-Mutated Cancers

A Phase I/Ib Study Evaluating Single-Agent Inavolisib, Inavolisib Plus Atezolizumab, and Inavolisib Plus Pembrolizumab in PIK3CA-Mutated Cancers

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Hoffmann-La Roche · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of the study is to assess the safety and efficacy of inavolisib as a single-agent, in combination with atezolizumab, and in combination with pembrolizumab in participants with phosphatidylinositol 4,5-bisphosphate 3-kinase catalytic subunit alpha isoform (PIK3CA)-mutated cancers, including previously treated head and neck squamous cell carcinoma (HNSCC).

Conditions

• PIK3CA-Mutated Cancers

Interventions

Type	Name	Description
DRUG	Inavolisib	Participants will receive inavolisib, 9 milligram (mg), PO, QD on Days 1-21 of each 21-day cycle.
DRUG	Atezolizumab	Participants will receive atezolizumab, 1200 mg, as IV infusion Q3W on Day 1 of each 21-day cycle.
DRUG	Pembrolizumab	Participants will receive pembrolizumab as an IV infusion Q3W on Day 1 of each 21-day cycle.

Timeline

• Start date: 2023-12-11
• Primary completion: 2028-09-28
• Completion: 2028-09-28
• First posted: 2024-07-11
• Last updated: 2026-04-16

Locations

8 sites across 3 countries: United States, Canada, South Korea

Regulatory

• FDA-regulated drug study