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.
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
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
Sequential
JAB 21822
DrugAdministered orally
Dose Escalation phase Number of participants with dose limiting toxicities (DLTs)
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.
Dose Escalation phase: Number of participants with adverse events
Patients will be assessed for incidence and severity of AEs according to NCI-CTCAE 5.0 criteria
Dose Expansion phase: Objective response rate (ORR)
ORR is defined as the percentage of participants with complete response (CR) or partial response (PR) per RECIST v 1.1
Dose Escalation phase: Objective response rate (ORR)
ORR is defined as the percentage of participants with complete response (CR) or partial response (PR) per RECIST v 1.1
Dose Escalation and Dose Expansion phase: Progression-free survival (PFS)
PFS is defined as the interval of time between the date of first treatment to the earliest date of disease progression per RECIST1.1 or death whichever occurs first
Dose Escalation and Dose Expansion phase: Duration of response (DOR)
DOR is defined as the time from the participant's initial objective response (CR or PR) to disease progression per RECIST v1.1 or death due to any cause, whichever occurs first.
Dose Escalation and Dose Expansion phase: Disease Control Rate (DCR)
DCR is defined as percentage of participants with complete response (CR), partial response (PR), or stable disease (SD) per RECIST v1.1
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