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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

Phase I / Phase II Interventional Non-small Cell Lung Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: JAB 21822.
Who it may be relevant to
Registry conditions: Non-small Cell Lung Cancer. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

A Phase Ib/II ,Single Arm, Multi-Center, Open Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Evidence of JAB-21822 in Advanced or Metastatic Non-small Cell Lung Cancer With a KRAS p.G12C and STK11 Co-mutation and Wild-type KEAP1

Overview

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.

Detailed description

The primary objective of this study is to evaluate the safety and tolerability of JAB-21822 during Dose Escalation phase and preliminary antitumor activity in patients with NSCLC with concurrent KRAS G12C mutant and STK11 mutant and KEAP wild type either treatment naïve or at least one line prior therapy for advance disease during the expansion phase..

Interventions

  • Drug JAB 21822
    Administered orally

Primary outcome measures

  • Dose Escalation phase Number of participants with dose limiting toxicities (DLTs) [Time frame: At the end of Cycle 1 (each cycle is 21 days)]
  • Dose Escalation phase: Number of participants with adverse events [Time frame: Up to 3 years]
  • Dose Expansion phase: Objective response rate (ORR) [Time frame: Up to 3 years - from baseline to confirmed Progressive Disease per RECIST.]
Secondary outcome measures (10)
  • Dose Escalation phase: Objective response rate (ORR) [Time frame: Up to 3 years - from baseline to RECIST confirmed Progressive Disease]
  • Dose Escalation and Dose Expansion phase: Progression-free survival (PFS) [Time frame: Up to 3 years]
  • Dose Escalation and Dose Expansion phase: Duration of response (DOR) [Time frame: Up to 3 years]
  • Dose Escalation and Dose Expansion phase: Disease Control Rate (DCR) [Time frame: Up to 3 years]
  • Dose Escalation and Dose Expansion phase: Overall Survival (OS) [Time frame: Up to 3 years]
  • Dose Escalation and Dose Expansion phase: Time to response (TTR) [Time frame: Up to 3 years]
  • Dose Expansion phase: Number of participants with adverse events [Time frame: Up to 3 years]
  • Dose Escalation and Dose Expansion phase: Plasma concentration (Cmax) [Time frame: Up to 3 Years]
  • Dose Escalation and Dose Expansion phase: Time to achieve Cmax (Tmax) [Time frame: Up to 3 Years]
  • Escalation and Dose Expansion phase：Area under the plasma concentration-time curve (AUC) [Time frame: Up to 3 Years]

Eligibility criteria

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Sequential
Masking
Open label
Primary purpose
Treatment

Study locations

China · 21 centers
  • Research site08 — Beijing
  • Research site09 — Beijing
  • Research site021 — Beijing
  • Research site02 — Beijing
  • Research site01 — Beijing
  • Research site013 — Beijing
  • Research site010 — Chongqing
  • Research site05 — Xiamen
  • … and 13 more centers

Identifiers

NCT: NCT05276726 · JAB-21822-1003

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗