Ignite Creation Date:
2024-05-06 @ 5:56 PM
Last Modification Date:
2024-10-26 @ 2:38 PM
Study NCT ID:
NCT05487235
Status:
RECRUITING
Last Update Posted:
2024-07-05
First Post:
2022-07-21
Brief Title:
A Study to Evaluate the Safety Pharmacokinetics and Activity of GDC-1971 in Combination With Atezolizumab in Participants With Locally Advanced or Metastatic Solid Tumors
Sponsor:
Genentech Inc
Organization:
Genentech Inc
Study Overview
Official Title:
A Phase Ib Open-Label Study Evaluating the Safety Pharmacokinetics and Activity of GDC-1971 in Combination With Atezolizumab in Patients With Locally Advanced or Metastatic Solid Tumors
Status:
RECRUITING
Status Verified Date:
2024-09
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 this study is to evaluate the safety pharmacokinetics PK and activity of GDC-1971 when administered in combination with atezolizumab in participants with locally advanced or metastatic solid tumors
The study will have 2 stages- dose finding stage and expansion stage In expansion stage participants with non-small cell lung cancer programmed death ligand -1 high NSCLC PD L-1 high NSCLC PD L-1 low head and neck squamous cell carcinoma HNSCC PD L-1 positive BRAF wild type BRAF WT melanoma and any locally advanced or metastatic solid tumors will be enrolled
The study will have 2 stages- dose finding stage and expansion stage In expansion stage participants with non-small cell lung cancer programmed death ligand -1 high NSCLC PD L-1 high NSCLC PD L-1 low head and neck squamous cell carcinoma HNSCC PD L-1 positive BRAF wild type BRAF WT melanoma and any locally advanced or metastatic solid tumors will be enrolled
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
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?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2021-006479-40 | EUDRACT_NUMBER | None | None |