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
1 other identifier
interventional
104
1 country
21
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1 nonsmall-cell-lung-cancer
Started Aug 2022
21 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 3, 2022
CompletedFirst Posted
Study publicly available on registry
March 11, 2022
CompletedStudy Start
First participant enrolled
August 17, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2026
CompletedApril 4, 2025
March 1, 2025
3.5 years
March 3, 2022
April 3, 2025
Conditions
Outcome Measures
Primary Outcomes (3)
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.
At the end of Cycle 1 (each cycle is 21 days)
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
Up to 3 years
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
Up to 3 years - from baseline to confirmed Progressive Disease per RECIST.
Secondary Outcomes (10)
Dose Escalation phase: Objective response rate (ORR)
Up to 3 years - from baseline to RECIST confirmed Progressive Disease
Dose Escalation and Dose Expansion phase: Progression-free survival (PFS)
Up to 3 years
Dose Escalation and Dose Expansion phase: Duration of response (DOR)
Up to 3 years
Dose Escalation and Dose Expansion phase: Disease Control Rate (DCR)
Up to 3 years
Dose Escalation and Dose Expansion phase: Overall Survival (OS)
Up to 3 years
- +5 more secondary outcomes
Study Arms (3)
Phase 1 ,Dose Exploration ,monotherapy
EXPERIMENTALDose escalation of JAB21822 will be administered as monotherapy to determine the MTD and RP2D
Phase 2, Dose Expansion, Part1 monotherapy
EXPERIMENTALPart 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)
Phase 2 Dose Expansion, Part 2 monotherapy
EXPERIMENTALPart 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
Interventions
Administered orally
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (21)
Research site08
Beijing, Beijing Municipality, 100010, China
Research site09
Beijing, Beijing Municipality, 100010, China
Research site021
Beijing, Beijing Municipality, 100032, China
Research site02
Beijing, Beijing Municipality, 100089, China
Research site01
Beijing, Beijing Municipality, 100101, China
Research site013
Beijing, Beijing Municipality, 101100, China
Research site010
Chongqing, Chongqing Municipality, 400000, China
Research site05
Xiamen, Fujian, 361000, China
Research site011
Shenzhen, Guangdong, 518000, China
Research site016
Nanning, Guangxi, 530000, China
Research site017
Shijiazhuang, Hebei, 050000, China
Research site018
Harbin, Heilongjiang, 150000, China
Research site04
Zhengzhou, Henan, 450000, China
Research site012
Changsha, Hunan, 410000, China
Research site015
Changchun, Jilin, 130000, China
Research site06
Shenyang, Liaoning, 110000, China
Research site07
Shenyang, Liaoning, 110000, China
Research site014
Hohhot, Neimenggu, 010000, China
Research site020
Xi’an, Shanxi, 710000, China
Research site03
Hubei, Wuhan, 430060, China
Research site019
Hangzhou, Zhejiang, 310000, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Shanghai Allist Pharmaceuticals Co., Ltd Shanghai Allist Pharmaceuticals Co., Ltd
CONTACT
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 3, 2022
First Posted
March 11, 2022
Study Start
August 17, 2022
Primary Completion
February 1, 2026
Study Completion
February 1, 2026
Last Updated
April 4, 2025
Record last verified: 2025-03
Data Sharing
- IPD Sharing
- Will not share