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NCT06496568 · ClinicalTrials.gov registry record · Phase 1
A Study Evaluating Single-agent Inavolisib, Inavolisib Plus Atezolizumab, and Inavolisib Plus Pembrolizumab in PIK3CA-Mutated Cancers
A Phase 1 study of PIK3CA-Mutated Cancers, sponsored by Hoffmann-La Roche.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 30
- Enrollment target
- 8
- Study locations
NCT06496568: Recruiting Phase 1 study of PIK3CA-Mutated Cancers, sponsored by Hoffmann-La Roche.
NCT06496568 is a Phase 1 study of PIK3CA-Mutated Cancers that is actively recruiting participants, run by Hoffmann-La Roche. The registered enrollment target is 30 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (50% lower). The trial reports 8 study locations across 6 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06496568, a Phase 1 study of PIK3CA-Mutated Cancers, is actively recruiting participants, sponsored by Hoffmann-La Roche.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 30 participants
- Enrollment target
- 8
- Study locations
Study 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 Studied
Interventions
- DRUG Pembrolizumab
- DRUG Atezolizumab
- DRUG Inavolisib
Study Locations (8)
California
- Moores Cancer Center at UC San Diego Health - La Jolla
- California Cancer Associates for Research & Excellence, Inc. - San Marcos
Other
- Seoul National University Hospital - Seoul
- Samsung Medical Center - Seoul
Tennessee
- Vanderbilt-Ingram Cancer Ctr - Nashville
British Columbia
- BC Cancer Vancouver Centre - Vancouver
Ontario
- Princess Margaret Cancer Center - Toronto
Quebec
- Jewish General Hospital - Montreal
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2023-12-11 |
| Est. Completion | 2028-09-28 |
| Phase | Phase 1 |
What NCT06496568 shows while recruiting
NCT06496568 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (50% lower).
The record links to 1 condition, with PIK3CA-Mutated Cancers appearing as the primary indexed condition, and to 3 interventions - of which Pembrolizumab is the first listed.
NCT06496568 lists 8 locations in 6 states (California, Other, Tennessee).
Frequently Asked Questions
What is clinical trial NCT06496568 about?
NCT06496568 is a clinical study titled "A Study Evaluating Single-agent Inavolisib, Inavolisib Plus Atezolizumab, and Inavolisib Plus Pembrolizumab in PIK3CA-Mutated Cancers". 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, includi...
What is the current status of trial NCT06496568?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 30 participants. The study started on 2023-12-11. Estimated completion is 2028-09-28.
What conditions does trial NCT06496568 study?
This clinical trial studies the following conditions: PIK3CA-Mutated Cancers.
What interventions are being tested in trial NCT06496568?
The interventions under investigation include: Pembrolizumab (DRUG), Atezolizumab (DRUG), Inavolisib (DRUG).
Who is sponsoring clinical trial NCT06496568?
This trial is sponsored by Hoffmann-La Roche, which has 909 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06496568 being conducted?
This trial has 8 study locations across California, Tennessee, British Columbia, Ontario, Quebec. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT06496568's enrollment target sits among peer trials
30 1332nd of 2000 higher than 561 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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