Evaluating JAB-21822 for advanced lung cancer with specific mutations
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
Run by Allist Pharmaceuticals, Inc. · NCT05276726 · Data updated 2026-11-12
This study is testing a new treatment called JAB-21822 to see if it can help people with advanced lung cancer who have certain genetic mutations.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 104 (estimated) |
| Sponsor | Allist Pharmaceuticals, Inc. Industry-sponsored |
| Drugs / interventions | radiation |
| Locations | 21 sites (Beijing, Beijing Municipality and 20 other locations) |
| Status | Recruiting |
| Started | August 17, 2022 |
| Main results expected | August 2027 |
| Study ends | August 2027 |
| Registry record updated | August 13, 2026 |
| Trial ID | NCT05276726 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include patients with advanced or metastatic NSCLC who have KRAS p.G12C and STK11 co-mutations and are either treatment-naïve or have received at least one prior therapy.
✕Probably not a fit
Patients with CNS metastases, severe uncontrolled medical conditions, or recent therapeutic radiation therapy may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study evaluates the safety, tolerability, and clinical activity of JAB-21822 in patients with advanced or metastatic non-small cell lung cancer (NSCLC) characterized by KRAS p.G12C and STK11 co-mutations. The trial consists of a Dose Escalation phase to assess safety and a subsequent Expansion phase to evaluate preliminary antitumor activity in treatment-naïve patients or those who have received at least one prior therapy. Participants will undergo molecular testing to confirm their eligibility based on specific genetic mutations.
Why it matters
Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with a specific genetic profile of lung cancer.
How similar studies have gone: While this approach is focused on a specific mutation profile, similar studies targeting KRAS mutations have shown promising results, indicating potential for success.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Pathologically documented, locally-advanced or metastatic NSCLC with KRAS p.G12C mutation identified through molecular testing. 2. STK11 co-mutation and KEAP1 Wild-Type (local confirmation) 3. Treatment naïve or have received at least 1 prior standard therapy for advanced NSCLC 4. ECOG 0-1 Exclusion Criteria: 1. Has CNS metastases or carcinomatous meningitis, except treated CNS metastases with no evidence of radiographic progression or hemorrhage for at least 28 days 2. Any severe and/or uncontrolled medical conditions 3. Active infection requiring systemic treatment within 7 days 4. Therapeutic radiation therapy within 3 weeks of study day 1
Where it's running
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Research site01
Beijing, Beijing Municipality, China Recruiting -
Research site08
Beijing, Beijing Municipality, China Not yet recruiting -
Research site09
Beijing, Beijing Municipality, China Not yet recruiting -
Research site021
Beijing, Beijing Municipality, China Not yet recruiting -
Research site02
Beijing, Beijing Municipality, China Not yet recruiting -
Research site013
Beijing, Beijing Municipality, China Not yet recruiting
Show 15 more locations
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Research site010
Chongqing, Chongqing Municipality, China Not yet recruiting -
Research site05
Xiamen, Fujian, China Not yet recruiting -
Research site011
Shenzhen, Guangdong, China Not yet recruiting -
Research site016
Nanning, Guangxi, China Not yet recruiting -
Research site017
Shijiazhuang, Hebei, China Not yet recruiting -
Research site018
Harbin, Heilongjiang, China Not yet recruiting -
Research site04
Zhengzhou, Henan, China Not yet recruiting -
Research site012
Changsha, Hunan, China Not yet recruiting -
Research site015
Changchun, Jilin, China Not yet recruiting -
Research site06
Shenyang, Liaoning, China Not yet recruiting -
Research site07
Shenyang, Liaoning, China Not yet recruiting -
Research site014
Hohhot, Neimenggu, China Not yet recruiting -
Research site020
Xi’an, Shanxi, China Not yet recruiting -
Research site03
Hubei, Wuhan, China Not yet recruiting -
Research site019
Hangzhou, Zhejiang, China Not yet recruiting
Study contacts
- Study coordinator: Shanghai Allist Pharmaceuticals Co., Ltd Shanghai Allist Pharmaceuticals Co., Ltd
- Email: zhenhua.gong@allist.com.cn
- Phone: 021-80423288
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.