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Recruiting
NCT05276726
A Study of JAB-21822 in Advanced or Metastatic NSCLC With KRAS p.G12C and STK11 Co-mutation and Wild-type KEAP1
Conditions: Non-small Cell Lung Cancer
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: PHASE1, PHASE2
Enrollment: 104
Sponsor: Allist Pharmaceuticals, Inc.
Location: Research site08 Beijing Beijing Municipality
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 Criteria
Inclusion Criteria:
1. Pathologically documented, locally-advanced or metastatic NSCLC with KRAS p.G12C mutation identified through molecular testing.
2. STK11 co-mutation and KEAP1 Wild-Type (local confirmation)
3. Treatment naïve or have received at least 1 prior standard therapy for advanced NSCLC
4. ECOG 0-1
Exclusion Criteria:
1. Has CNS metastases or carcinomatous meningitis, except treated CNS metastases with no evidence of radiographic progression or hemorrhage for at least 28 days
2. Any severe and/or uncontrolled medical conditions
3. Active infection requiring systemic treatment within 7 days
4. Therapeutic radiation therapy within 3 weeks of study day 1
Source: ClinicalTrials.gov (NCT05276726). StuddyBuddy aggregates publicly available trial information.