Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05276726 | A Study of JAB-21822 in Advanced or Metastatic NSCLC With KRAS p.G12C and STK11 Co-mutation and Wild-type KEAP1 | PHASE1 | RECRUITING | 104 | — | — | Aug 17, 2022 | Feb 1, 2026 | Apr 4, 2025 | 21 | China |
A DLT is defined as the clinically significant treatment-related adverse event or abnormal laboratory values assessment during the first 21 days of Cycle 1. It excludes adverse events (AEs) that are deemed clearly related to underlying disease, progression, or intercurrent illness.
Patients will be assessed for incidence and severity of AEs according to NCI-CTCAE 5.0 criteria
ORR is defined as the percentage of participants with complete response (CR) or partial response (PR) per RECIST v 1.1
| Arm | Type | Description |
|---|---|---|
| Phase 1 ,Dose Exploration ,monotherapy | EXPERIMENTAL | Dose escalation of JAB21822 will be administered as monotherapy to determine the MTD and RP2D |
| Phase 2, Dose Expansion, Part1 monotherapy | EXPERIMENTAL | Part 1 dose expansion is to evaluate the safety and clinical activity of JAB-21822 at RP2D in subjects with previously untreated advanced non-small cell lung cancer (NSCLC) |
| Phase 2 Dose Expansion, Part 2 monotherapy | EXPERIMENTAL | Part 2 dose expansion is to evaluate the safety and clinical activity of JAB-21822 at RP2D in subjects who had received at least one previous line of systemic therapy for NSCLC |
| Name | Type | Description |
|---|---|---|
| JAB 21822 | DRUG | Administered orally |
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 NSC...