Status:
RECRUITING
A Study of JAB-21822 in Advanced or Metastatic NSCLC With KRAS p.G12C and STK11 Co-mutation and Wild-type KEAP1
Lead Sponsor:
Allist Pharmaceuticals, Inc.
Conditions:
Non-small Cell Lung Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
Evaluate the safety and tolerability, drug levels, and clinical activity of JAB-21822 in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) whose tumors with KRAS p.G12C m...
Detailed Description
The primary objective of this study is to evaluate the safety and tolerability of JAB-21822 during Dose Escalation phase and preliminary antitumor activity in patients with NSCLC with concurrent KRAS ...
Eligibility Criteria
Inclusion
- Pathologically documented, locally-advanced or metastatic NSCLC with KRAS p.G12C mutation identified through molecular testing.
- STK11 co-mutation and KEAP1 Wild-Type (local confirmation)
- Treatment naïve or have received at least 1 prior standard therapy for advanced NSCLC
- ECOG 0-1
Exclusion
- Has CNS metastases or carcinomatous meningitis, except treated CNS metastases with no evidence of radiographic progression or hemorrhage for at least 28 days
- Any severe and/or uncontrolled medical conditions
- Active infection requiring systemic treatment within 7 days
- Therapeutic radiation therapy within 3 weeks of study day 1
Key Trial Info
Start Date :
August 17 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2026
Estimated Enrollment :
104 Patients enrolled
Trial Details
Trial ID
NCT05276726
Start Date
August 17 2022
End Date
February 1 2026
Last Update
April 4 2025
Active Locations (21)
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1
Research site08
Beijing, Beijing Municipality, China, 100010
2
Research site09
Beijing, Beijing Municipality, China, 100010
3
Research site021
Beijing, Beijing Municipality, China, 100032
4
Research site02
Beijing, Beijing Municipality, China, 100089