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

NCT05009329 | Active Not Recruiting Phase 1

• 1 other identifier: JAB-21822-1002
• Study Type: interventional
• Target: 315
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Solid Tumor; NSCLC

Keywords

KRAS p.G12C Mutant Advanced Solid Tumor; NSCLC

Outcome Measures

Primary Outcomes (3)

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

  Number of participants with dose limiting toxicities

  first 21 days

• Number of participants with adverse events

  Patients will be assessed for incidence and severity of adverse events (AEs) according to NCI-CTCAE criteria

  up to 3 years

• 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

  up to 3 years

Secondary Outcomes (6)

• Overall response rate (ORR) by investigator

  up to 3 years

• Duration of response ( DOR )

  up to 3 years

• Disease Control Rate ( DCR )

  up to 3 years

• Progression-free survival (PFS)

  up to 3 years

• Time to response (TTR)

  up to 3 years

Study Arms (3)

Phase 1 Dose Exploration

EXPERIMENTAL

Dose escalation of JAB-21822 to determine maximum tolerated dose.

Drug: JAB-21822

Phase IIa Dose Expansion

EXPERIMENTAL

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.

Drug: JAB-21822

Phase IIb

EXPERIMENTAL

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.

Drug: JAB-21822

Interventions

JAB-21822 DRUG

JAB-21822 will be administered orally

Also known as: glecirasib

Phase 1 Dose Exploration

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Allist Pharmaceuticals, Inc.: lead

Study Sites (1)

Beijing Cancer Hospital

Beijing, Beijing Municipality, 100142, China

Location

Related Publications (3)

• 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.

  PMID: 41344351 DERIVED

• 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.

  PMID: 41037823 DERIVED

• 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.

  PMID: 39762419 DERIVED

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

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: July 26, 2021
• First Posted: August 17, 2021
• Study Start: July 26, 2021
• Primary Completion: May 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: March 13, 2026

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)