Ignite Creation Date:
2025-12-24 @ 2:12 PM
Ignite Modification Date:
2025-12-25 @ 12:51 PM
Study NCT ID:
NCT07207395
Status:
RECRUITING
Last Update Posted:
2025-10-06
First Post:
2025-10-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study of Orally Administered JBI-802 Alone or in Combination With Pembrolizumab for Patients With Non-small Cell Lung Cancer With an STK11 Mutation.
Sponsor:
The Christ Hospital
Organization:
Study Overview
Official Title:
A Study of Open-label Orally Administered JBI-802 Alone or in Combination With Pembrolizumab in Patients With Advanced NSCLC Tumors Harboring an STK11 Mutation
Status:
RECRUITING
Status Verified Date:
2025-10
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 determine the overall safety and tolerability of JBI-802 as single agent and in combination with Pembrolizumab.
Detailed Description:
This is a single site, open-label, study to define the safety profile and overall response rate (ORR) and duration of response (DOR) activity of JBI-802 alone and in combination with Pembrolizumab in participants with Non-Small Cell Lung Cancer harboring an STK11 mutation. Dose of study medication will be 10 mg orally once daily, 4 days on and 3 days off cycle. Dose of Pembrolizumab will be 200mg every 3 weeks.
Study Oversight
Has Oversight DMC:
True
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?: