RecruitingPhase 1Phase 2NCT05276726

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

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


Sponsor

Allist Pharmaceuticals, Inc.

Enrollment

104 participants

Start Date

Aug 17, 2022

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests JAB-21822, a targeted drug for non-small cell lung cancer (NSCLC) that has a specific combination of genetic mutations: KRAS G12C mutation, STK11 co-mutation, and wild-type (normal) KEAP1. **You may be eligible if...** - You have locally advanced or metastatic NSCLC confirmed by molecular testing - Your tumor has both the KRAS G12C mutation and an STK11 co-mutation, with normal KEAP1 - You are treatment-naive or have received at least one prior standard therapy for advanced NSCLC - Your performance status is good (ECOG 0–1) **You may NOT be eligible if...** - You have active, untreated brain metastases or cancer spread to the lining around the brain - You have had radiation therapy within 3 weeks before starting treatment - You have an active infection requiring treatment - You have other serious uncontrolled medical conditions Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGJAB 21822

Administered orally


Locations(21)

Research site08

Beijing, Beijing Municipality, China

Research site09

Beijing, Beijing Municipality, China

Research site021

Beijing, Beijing Municipality, China

Research site02

Beijing, Beijing Municipality, China

Research site01

Beijing, Beijing Municipality, China

Research site013

Beijing, Beijing Municipality, China

Research site010

Chongqing, Chongqing Municipality, China

Research site05

Xiamen, Fujian, China

Research site011

Shenzhen, Guangdong, China

Research site016

Nanning, Guangxi, China

Research site017

Shijiazhuang, Hebei, China

Research site018

Harbin, Heilongjiang, China

Research site04

Zhengzhou, Henan, China

Research site012

Changsha, Hunan, China

Research site015

Changchun, Jilin, China

Research site06

Shenyang, Liaoning, China

Research site07

Shenyang, Liaoning, China

Research site014

Hohhot, Neimenggu, China

Research site020

Xi’an, Shanxi, China

Research site03

Hubei, Wuhan, China

Research site019

Hangzhou, Zhejiang, China

View Full Details on ClinicalTrials.gov

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NCT05276726


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