Ignite Creation Date:
2025-12-24 @ 5:30 PM
Ignite Modification Date:
2026-01-13 @ 9:14 AM
Study NCT ID:
NCT06496568
Status:
RECRUITING
Last Update Posted:
2025-12-01
First Post:
2024-07-04
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study Evaluating Single-agent Inavolisib and Inavolisib Plus Atezolizumab in PIK3CA-Mutated Cancers
Sponsor:
Hoffmann-La Roche
Organization:
Study Overview
Official Title:
A Phase I/Ib Study Evaluating Single-Agent Inavolisib and Inavolisib Plus Atezolizumab in PIK3CA-Mutated Cancers
Status:
RECRUITING
Status Verified Date:
2025-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of the study is to assess the safety and efficacy of inavolisib as a single-agent and in combination with atezolizumab 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).
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 2021-006618-36 | EUDRACT_NUMBER | None | View |