A Study of JAB-21822 in Advanced or Metastatic NSCLC With KRAS p.G12C and STK11 Co-mutation and Wild-type KEAP1

Browse trials for

• Carcinoma, Non-Small-Cell Lung 6,475

Study arms

• Experimental
  Phase 1 ,Dose Exploration ,monotherapy

  Dose escalation of JAB21822 will be administered as monotherapy to determine the MTD and RP2D

  Drug: JAB 21822

• Experimental
  Phase 2, Dose Expansion, Part1 monotherapy

  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)

  Drug: JAB 21822

• Experimental
  Phase 2 Dose Expansion, Part 2 monotherapy

  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

  Drug: JAB 21822

Interventions

• DrugJAB 21822

  Administered orally

Primary outcomes

1. 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.

   Time frame: At the end of Cycle 1 (each cycle is 21 days)

2. 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

   Time frame: Up to 3 years

3. 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

   Time frame: Up to 3 years - from baseline to confirmed Progressive Disease per RECIST.

Secondary outcomes

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

   Time frame: Up to 3 years - from baseline to RECIST confirmed Progressive Disease

2. 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

   Time frame: Up to 3 years

3. 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.

   Time frame: Up to 3 years

4. 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

   Time frame: Up to 3 years

5. Dose Escalation and Dose Expansion phase: Overall Survival (OS)

   Defined as time from first treatment to death by any cause

   Time frame: Up to 3 years

6. Dose Escalation and Dose Expansion phase: Time to response (TTR)

   Defined as time from first treatment to first evidence of PR or CR

   Time frame: Up to 3 years

7. Dose Expansion phase: Number of participants with adverse events

   Patients will be assessed for incidence and severity of adverse events (AEs) according to NCI-CTCAE criteria

   Time frame: Up to 3 years

8. Dose Escalation and Dose Expansion phase: Plasma concentration (Cmax)

   Cmax of JAB-21822 will be measured by using plasma PK samples

   Time frame: Up to 3 Years

9. Dose Escalation and Dose Expansion phase: Time to achieve Cmax (Tmax)

   Tmax of JAB-21822 will be measured by using plasma PK samples

   Time frame: Up to 3 Years

10. Escalation and Dose Expansion phase：Area under the plasma concentration-time curve (AUC)

    AUC of JAB-21822 will be measured by using plasma PK samples

    Time frame: Up to 3 Years

Individual participant data

Plan to share: No