Non-small Cell Lung CancerPhase 1/2NCT05276726
A Study of JAB-21822 in Advanced or Metastatic NSCLC With KRAS p.G12C and STK11 Co-mutation and Wild-type KEAP1
A Phase 1/2 study testing JAB 21822 in people with Non-small Cell Lung Cancer, run by Allist Pharmaceuticals, Inc. at 21 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-small Cell Lung Cancer
- What is being tested?
- JAB 21822
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 104 participants
- Where
- 21 sitesChina
- Study dates
- 17 Aug 2022to Aug 2027
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
21 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Shanghai Allist Pharmaceuticals Co., Ltd Shanghai Allist Pharmaceuticals Co., Ltd contact
21 sites in 1 country
China21 sites, 21 recruiting
- Not yet recruiting
Research site08
Beijing, Beijing Municipality, 100010
- Not yet recruiting
Research site09
Beijing, Beijing Municipality, 100010
- Not yet recruiting
Research site021
Beijing, Beijing Municipality, 100032
- Not yet recruiting
Research site02
Beijing, Beijing Municipality, 100089
- Recruiting
Research site01
Beijing, Beijing Municipality, 100101
Wang Jie Wang Jie M.D., M.D., 010-87788029, zlhuxi@163.com
- Not yet recruiting
Research site013
Beijing, Beijing Municipality, 101100
- Not yet recruiting
Research site015
Changchun, Jilin, 130000
- Not yet recruiting
Research site012
Changsha, Hunan, 410000
- Not yet recruiting
Research site010
Chongqing, Chongqing Municipality, 400000
- Not yet recruiting
Research site019
Hangzhou, Zhejiang, 310000
- Not yet recruiting
Research site018
Harbin, Heilongjiang, 150000
- Not yet recruiting
Research site014
Hohhot, Neimenggu, 010000
- Not yet recruiting
Research site03
Hubei, Wuhan, 430060
- Not yet recruiting
Research site016
Nanning, Guangxi, 530000
- Not yet recruiting
Research site06
Shenyang, Liaoning, 110000
- Not yet recruiting
Research site07
Shenyang, Liaoning, 110000
- Not yet recruiting
Research site011
Shenzhen, Guangdong, 518000
- Not yet recruiting
Research site017
Shijiazhuang, Hebei, 050000
- Not yet recruiting
Research site020
Xi’an, Shanxi, 710000
- Not yet recruiting
Research site05
Xiamen, Fujian, 361000
- Not yet recruiting
Research site04
Zhengzhou, Henan, 450000
About this study
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
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.
Read the 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..
- Conditions
- Non-small Cell Lung Cancer
- Being tested
- JAB 21822
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
JAB 21822Drug
Administered orally
| Study group | Role | What they receive |
|---|---|---|
| Phase 1 ,Dose Exploration ,monotherapy | Experimental | Dose escalation of JAB21822 will be administered as monotherapy to determine the MTD and RP2D Receives: Drug: JAB 21822 |
| Phase 2, Dose Expansion, Part1 monotherapy | Experimental | 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) Receives: Drug: JAB 21822 |
| Phase 2 Dose Expansion, Part 2 monotherapy | Experimental | 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 Receives: Drug: JAB 21822 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 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
Measured: Up to 3 years - from baseline to confirmed Progressive Disease per RECIST.
Secondary outcomes (10)
Dose Escalation 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
Measured: Up to 3 years - from baseline to RECIST confirmed Progressive Disease
Dose Escalation and Dose Expansion phase: Progression-free survival (PFS)
PFS is defined as the interval of time between the date of first treatment to the earliest date of disease progression per RECIST1.1 or death whichever occurs first
Measured: Up to 3 years
Dose Escalation and Dose Expansion phase: Duration of response (DOR)
DOR is defined as the time from the participant's initial objective response (CR or PR) to disease progression per RECIST v1.1 or death due to any cause, whichever occurs first.
Measured: Up to 3 years
Dose Escalation and Dose Expansion phase: Disease Control Rate (DCR)
DCR is defined as percentage of participants with complete response (CR), partial response (PR), or stable disease (SD) per RECIST v1.1
Measured: Up to 3 years
Dose Escalation and Dose Expansion phase: Overall Survival (OS)
Defined as time from first treatment to death by any cause
Measured: Up to 3 years
Dose Escalation and Dose Expansion phase: Time to response (TTR)
Defined as time from first treatment to first evidence of PR or CR
Measured: Up to 3 years
Dose Expansion phase: Number of participants with adverse events
Patients will be assessed for incidence and severity of adverse events (AEs) according to NCI-CTCAE criteria
Measured: Up to 3 years
Dose Escalation and Dose Expansion phase: Plasma concentration (Cmax)
Cmax of JAB-21822 will be measured by using plasma PK samples
Measured: Up to 3 Years
Dose Escalation and Dose Expansion phase: Time to achieve Cmax (Tmax)
Tmax of JAB-21822 will be measured by using plasma PK samples
Measured: Up to 3 Years
Escalation and Dose Expansion phase：Area under the plasma concentration-time curve (AUC)
AUC of JAB-21822 will be measured by using plasma PK samples
Measured: Up to 3 Years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2022
- Study start17 Aug 2022
- Primary completionAug 2027 (estimated)
- Study completionAug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-small Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by Allist Pharmaceuticals, Inc.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 104 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Allist Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05276726
- Sponsor's protocol ID
- JAB-21822-1003
- Status last verified
- Aug 2026
- First submitted
- 3 Mar 2022
- Last updated
- 13 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05276726
- Acronym / sponsor ID
- JAB-21822-1003
- Conditions
- Non-small Cell Lung Cancer
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 104 participants (estimated)
- Lead sponsor
- Allist Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- 17 Aug 2022 (actual)
- Primary completion
- Aug 2027 (estimated)
- Study completion
- Aug 2027 (estimated)
- First posted
- 11 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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..
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Phase 1 ,Dose Exploration ,monotherapy | Experimental | Drug: JAB 21822Dose escalation of JAB21822 will be administered as monotherapy to determine the MTD and RP2D |
| Phase 2, Dose Expansion, Part1 monotherapy | Experimental | Drug: JAB 21822Part 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 | Experimental | Drug: JAB 21822Part 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| JAB 21822Administered orally | Drug | Phase 1 ,Dose Exploration ,monotherapy, Phase 2 Dose Expansion, Part 2 monotherapy, Phase 2, Dose Expansion, Part1 monotherapy |
Primary outcome
Dose Escalation phase Number of participants with dose limiting toxicities (DLTs)
Time frame: At the end of Cycle 1 (each cycle is 21 days)
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.
Dose Escalation phase: Number of participants with adverse events
Time frame: Up to 3 years
Patients will be assessed for incidence and severity of AEs according to NCI-CTCAE 5.0 criteria
Dose Expansion phase: Objective response rate (ORR)
Time frame: Up to 3 years - from baseline to confirmed Progressive Disease per RECIST.
ORR is defined as the percentage of participants with complete response (CR) or partial response (PR) per RECIST v 1.1
10 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Shanghai Allist Pharmaceuticals Co., Ltd Shanghai Allist Pharmaceuticals Co., Ltd contact
21 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing JAB 21822 in people with Non-small Cell Lung Cancer, run by Allist Pharmaceuticals, Inc. at 21 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 21 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Shanghai Allist Pharmaceuticals Co., Ltd Shanghai Allist Pharmaceuticals Co., Ltd (021-80423288, zhenhua.gong@allist.com.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dose Escalation phase Number of participants with dose limiting toxicities (DLTs) (time frame: At the end of Cycle 1 (each cycle is 21 days)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Aug 2026.