RecruitingPhase 1Phase 2NCT05276726
A Study of JAB-21822 in Advanced or Metastatic NSCLC With KRAS p.G12C and STK11 Co-mutation and Wild-type KEAP1
A Phase Ib/II ,Single Arm, Multi-Center, Open Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Evidence of JAB-21822 in Advanced or Metastatic Non-small Cell Lung Cancer With a KRAS p.G12C and STK11 Co-mutation and Wild-type KEAP1
Sponsor
Allist Pharmaceuticals, Inc.
Enrollment
104 participants
Start Date
Aug 17, 2022
Study Type
INTERVENTIONAL
Conditions
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 mutation and a serine/threonine kinase 11 (STK11) co-mutation.
Eligibility
Min Age: 18 Years
Inclusion Criteria4
- 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 Criteria4
- 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
Interventions
DRUGJAB 21822
Administered orally
Locations(21)
View Full Details on ClinicalTrials.gov
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NCT05276726
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