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NSCLCPhase 1/2NCT05009329

A Study of JAB-21822 in Adult Patients With Advanced Solid Tumors Harboring KRAS p.G12C Mutation in China

A Phase 1/2 study testing JAB-21822 in people with NSCLC and Solid Tumor, run by Allist Pharmaceuticals, Inc. at 1 site in China.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

To assess safety, tolerability, PK, efficacy and determine recommended phase 2 dose (RP2D) of JAB-21822 (glecirasib) administered in adult participants with KRAS p.G12C-mutant advanced solid tumors. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
NSCLC, Solid Tumor
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
315 participants
Where
1 siteChina
Study dates
26 Jul 2021to Dec 2026
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

  • Written informed consent
  • Advanced (metastatic or unresectable) KRAS p.G12C mutant solid tumors, with failure or absence of standard treatment
  • Subject must be ≥18 years
  • Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1.
  • Subjects with life expectancy ≥3 months.
  • Subjects must have at least one measurable lesion as defined by RECIST v1.1.
  • There was no serious organ dysfunction in the screening stage
  • Male or female subjects of reproductive age agree to use adequate contraception

Who cannot join

  • History of intestinal disease or major gastric surgery or inability to swallow oral medications
  • Other active cancer
  • Previously treated with KRAS G12C inhibitor
  • Active infection including hepatitis B, hepatitis C and human immunodeficiency virus (HIV)
  • Impaired heart function or clinically significant heart disease
  • Pregnant or breast-feeding
Show all 9Show fewer
  • Previous allogeneic bone marrow transplant or organ transplant
  • Intended study subjects who were unable to abstain from alcohol during medication
  • Other unqualified conditions judged by the investigators

Trial locations and contacts

1 site in 1 country.

China1 site

  • Beijing Cancer Hospital

    Beijing, Beijing Municipality, 100142

Other trials in China

About this study

Official title: Multi-center, Open, Dose-escalation, and Expanded Phase I/II Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Antitumor Activity of JAB-21822 in Advanced Solid Tumors With KRAS p.G12C Mutation

To assess safety, tolerability, PK, efficacy and determine recommended phase 2 dose (RP2D) of JAB-21822 (glecirasib) administered in adult participants with KRAS p.G12C-mutant advanced solid tumors.

Conditions
NSCLC, Solid Tumor
Being tested
JAB-21822
Keywords
KRAS p.G12C Mutant Advanced Solid Tumor; NSCLC
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

    Also called glecirasib

    JAB-21822 will be administered orally

  • JAB-21822Drug

    Also called glecirasib

    JAB-21822 will be administered orally

  • JAB-21822Drug

    Also called glecirasib

    JAB-21822 will be administered orally

Study groups in NCT05009329
Study groupRoleWhat they receive
Phase 1 Dose ExplorationExperimentalDose escalation of JAB-21822 to determine maximum tolerated dose.
Receives: Drug: JAB-21822
Phase IIa Dose ExpansionExperimentalPatients with KRAS p.G12C mutant advanced non small cell lung cancer or other solid tumors will be enrolled and treated at the monotherapy RP2D to evaluate the safety and preliminary efficacy.
Receives: Drug: JAB-21822
Phase IIbExperimentalPatients with KRAS p.G12C mutant advanced non small cell lung cancer will be enrolled and treated at the monotherapy RP2D to evaluate the safety and efficacy.
Receives: Drug: JAB-21822

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence of dose limiting toxicities (DLTs) in the dose escalation phase

    Number of participants with dose limiting toxicities

    Measured: first 21 days

  2. 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

  3. Overall response rate (ORR) by IRC (independent review committee)

    ORR is defined as the proportion of participants with complete response and partial response (CR+PR) per RECIST v 1.1

    Measured: up to 3 years

Secondary outcomes (6)

  1. Overall response rate (ORR) by investigator

    ORR is defined as the proportion of participants with complete response and partial response (CR+PR) per RECIST v 1.1

    Measured: up to 3 years

  2. Duration of response ( DOR )

    DOR is defined as the time from the participant's initial objective response (CR or PR) to study drug therapy, to disease progression or death due to any cause, whichever occurs first.

    Measured: up to 3 years

  3. Disease Control Rate ( DCR )

    DCR is defined as percentage of participants with complete response (CR), partial response (PR), and stable disease(SD) per RECIST v1.1

    Measured: up to 3 years

  4. 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 or death per RECIST v1.1, which occurs first

    Measured: up to 3 years

  5. Time to response (TTR)

    Time from patient randomization (first treatment) to first response per RECIST 1.1 criteria

    Measured: up to 3 years

  6. Peak Plasma Concentration (Cmax)

    Cmax 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.

  1. First posted17 Aug 2021
  2. Study start26 Jul 2021
  3. Primary completionAug 2026 (estimated)
  4. Study completionDec 2026 (estimated)

Resources

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
315 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05009329
Sponsor's protocol ID
JAB-21822-1002
Status last verified
Aug 2026
First submitted
26 Jul 2021
Last updated
13 Aug 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Jiang L, Luo Y, Liang H, Feng X, Huang Y, Li Y, Wang Z, Xu T, Zou H, Li Z, Shen L, Chen Y, Wang W, Li J. The dynamic evolution of circulating tumor cells during glecirasib treatment predicts survival and resistance in gastrointestinal tumors with KRASG12C mutation. Hum Cell. 2026 Jul 1;39(7):95. doi: 10.1007/s13577-026-01405-0.

    PubMed 42384131

  • Li J, Wang Z, Huang J, Ba Y, Cao B, Luo S, Li W, Bai C, Song Z, Xiong J, Zhu L, An G, Zhang Y, Li Z, Li Y, Gu Y, Hu C, Li X, Huang C, Fu Q, Yin X, Liang X, Zhong D, Shi H, Li X, Li Z, Liu L, Wang F, Liang R, Xia G, Wang Z, Wang-Gillam A, Ding Y, Rao Z, Pan W, Lu S, Sun X, Shen L. Glecirasib with or without cetuximab in previously treated locally advanced or metastatic colorectal cancer with KRASG12C mutation (JAB-21822-1002 and JAB-21822-1007): two open-label, non-randomised phase 1/2 trials. Lancet Gastroenterol Hepatol. 2026 Feb;11(2):110-123. doi: 10.1016/S2468-1253(25)00267-5. Epub 2025 Dec 1.

    PubMed 41344351

  • Li J, Deng T, Gu Y, Calles Blanco A, Li Z, Bai C, Wu L, Huang J, Li X, Yao Y, Song Z, Li Y, Liu L, Xing L, Wu W, Martinez-Perez J, Hubert A, Zugazagoitia J, Zhang J, Wang Y, Zhao Y, Wen G, Xia G, Zhong D, Chen X, Jiang K, Wang-Gillam A, Ding Y, Liu S, Rao Z, Liu X, Shen L. Efficacy and safety of glecirasib in solid tumors with KRAS G12C mutation: A pooled analysis of two phase I/II trials. Cancer Commun (Lond). 2025 Nov;45(11):1500-1512. doi: 10.1002/cac2.70056. Epub 2025 Oct 2.

    PubMed 41037823

  • Shi Y, Fang J, Xing L, Yao Y, Zhang J, Liu L, Wang Y, Hu C, Xiong J, Liu Z, Yang R, Wang Z, Zhao E, Wang M, Zhao Y, Tang K, Li Z, Song Z, Li Y, Zhuang W, Jin B, Cheng Y, Hu Y, Gu Y, Wu L, Ma R, Yu Q, Yu Y, Zhao J, Zhao H, Lv D, Shang Y, Xing P, Zhou J, Li X, Liu Z, Dai Z, Xia G, Chen X, Ba Y, Bai C, Li Q, An G, Hu W, Wang Y, Wang-Gillam A, Ding Y, Li Q, Rao Z. Glecirasib in KRASG12C-mutated nonsmall-cell lung cancer: a phase 2b trial. Nat Med. 2025 Mar;31(3):894-900. doi: 10.1038/s41591-024-03401-z. Epub 2025 Jan 6.

    PubMed 39762419

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing JAB-21822 in people with NSCLC and Solid Tumor, run by Allist Pharmaceuticals, Inc. at 1 site 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 8 inclusion and 9 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: under way, not looking for participants, 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 1 site 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?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of dose limiting toxicities (DLTs) in the dose escalation phase (time frame: first 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?

On the ClinicalTrials.gov record for NCT05009329, which also lists 4 linked publications.

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.

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