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
Who is this study for? Patients with advanced or metastatic non-small cell lung cancer with a KRAS p.G12C and STK11 co-mutation and wild-type KEAP1
What treatments are being studied? JAB 21822
Status: Recruiting
Location: See all (21) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1/Phase 2
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 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
Locations
Other Locations
China
Research site01
RECRUITING
Beijing
Research site013
NOT_YET_RECRUITING
Beijing
Research site02
NOT_YET_RECRUITING
Beijing
Research site021
NOT_YET_RECRUITING
Beijing
Research site08
NOT_YET_RECRUITING
Beijing
Research site09
NOT_YET_RECRUITING
Beijing
Research site015
NOT_YET_RECRUITING
Changchun
Research site012
NOT_YET_RECRUITING
Changsha
Research site010
NOT_YET_RECRUITING
Chongqing
Research site019
NOT_YET_RECRUITING
Hangzhou
Research site018
NOT_YET_RECRUITING
Harbin
Research site014
NOT_YET_RECRUITING
Hohhot
Research site03
NOT_YET_RECRUITING
Hubei
Research site016
NOT_YET_RECRUITING
Nanning
Research site06
NOT_YET_RECRUITING
Shenyang
Research site07
NOT_YET_RECRUITING
Shenyang
Research site011
NOT_YET_RECRUITING
Shenzhen
Research site017
NOT_YET_RECRUITING
Shijiazhuang
Research site020
NOT_YET_RECRUITING
Xi’an
Research site05
NOT_YET_RECRUITING
Xiamen
Research site04
NOT_YET_RECRUITING
Zhengzhou
Contact Information
Primary
Shanghai Allist Pharmaceuticals Co., Ltd Shanghai Allist Pharmaceuticals Co., Ltd
zhenhua.gong@allist.com.cn
021-80423288
Backup
Wang Jie Wang Jie M.D.
zlhuxi@163.com
010-87788029
Time Frame
Start Date: 2022-08-17
Estimated Completion Date: 2026-02
Participants
Target number of participants: 104
Treatments
Experimental: Phase 1 ,Dose Exploration ,monotherapy
Dose escalation of JAB21822 will be administered as monotherapy to determine the MTD and RP2D
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)
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
Related Therapeutic Areas
Sponsors
Leads: Allist Pharmaceuticals, Inc.