Overview

Phase Ib/II Study of JAB-21822 in Advanced or Metastatic NSCLC With KRAS p.G12C and STK11 Co-mutation

Status:
Not yet recruiting
Trial end date:
2026-02-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 1/Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Jacobio Pharmaceuticals Co., Ltd.
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