NCT07207395

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.

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
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: The Christ Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Lung Cancer (NSCLC)

Interventions

Type	Name	Description
DRUG	JBI-802	LSD1/HDAC6 Inhibitor
DRUG	Pembrolizumab	PD-1

Timeline

• Start date: 2025-04-29
• Primary completion: 2027-10-01
• Completion: 2028-10-01
• First posted: 2025-10-06
• Last updated: 2025-10-06

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study