A Study of JAB-21822 in Adult Patients With Advanced Solid Tumors Harboring KRAS p.G12C Mutation in China
NCT ID: NCT05009329
Last Updated: 2025-04-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
ACTIVE_NOT_RECRUITING
PHASE1/PHASE2
311 participants
INTERVENTIONAL
2021-07-26
2025-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Phase 1/2a Study of JAB-21822 Plus JAB-3312 in Patients With Advanced Solid Tumors Harboring KRAS p.G12C Mutation
NCT05288205
A Study of JAB-3312 in Adult Patients With Advanced Solid Tumors in China
NCT04121286
ZZ06 in Adult Patients With Advanced Solid Tumor Malignancies
NCT04412616
Study of GV20-0251 in Participants With Solid Tumor Malignancies
NCT07070518
Efficacy and Safety of IBI351 in Combination With Chemotherapy in Advanced Non-squamous Non-small Cell Lung Cancer Subjects With KRAS G12C Mutation
NCT05504278
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Phase 1 Dose Exploration
Dose escalation of JAB-21822 to determine maximum tolerated dose.
JAB-21822
JAB-21822 will be administered orally
Phase IIa Dose Expansion
Patients 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.
JAB-21822
JAB-21822 will be administered orally
Phase IIb
Patients 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.
JAB-21822
JAB-21822 will be administered orally
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
JAB-21822
JAB-21822 will be administered orally
JAB-21822
JAB-21822 will be administered orally
JAB-21822
JAB-21822 will be administered orally
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
2. Advanced (metastatic or unresectable) KRAS p.G12C mutant solid tumors, with failure or absence of standard treatment
3. Subject must be ≥18 years
4. Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1.
5. Subjects with life expectancy ≥3 months.
6. Subjects must have at least one measurable lesion as defined by RECIST v1.1.
7. There was no serious organ dysfunction in the screening stage
8. Male or female subjects of reproductive age agree to use adequate contraception
Exclusion Criteria
2. Other active cancer
3. Previously treated with KRAS G12C inhibitor
4. Active infection including hepatitis B, hepatitis C and human immunodeficiency virus (HIV)
5. Impaired heart function or clinically significant heart disease
6. Pregnant or breast-feeding
7. Previous allogeneic bone marrow transplant or organ transplant
8. Intended study subjects who were unable to abstain from alcohol during medication
9. Other unqualified conditions judged by the investigators
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Allist Pharmaceuticals, Inc.
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Beijing Cancer Hospital
Beijing, Beijing Municipality, China
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Li J, Deng T, Gu Y, Blanco AC, 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 Oct 2. doi: 10.1002/cac2.70056. Online ahead of print.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
JAB-21822-1002
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.