^
    6d
    Glecirasib Combined With Ivonescimab for First-line Treatment of KRAS G12C-mutated NSCLC (clinicaltrials.gov)
    P1/2, N=42, Not yet recruiting, Cancer Institute and Hospital, Chinese Academy of Medical Sciences
    New P1/2 trial
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    PD-L1 (Programmed death ligand 1) • KRAS (KRAS proto-oncogene GTPase)
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    KRAS mutation • KRAS G12C • KRAS G12
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    Airuikai (glecirasib) • Yidafan (ivonescimab)
    7d
    JAB-21822 Activity in Adult Patients With Advanced Solid Tumors Harboring KRAS G12C Mutation (clinicaltrials.gov)
    P1/2, N=29, Completed, Jacobio Pharmaceuticals Co., Ltd. | Recruiting --> Completed | N=100 --> 29 | Trial completion date: Jul 2025 --> Feb 2025 | Trial primary completion date: Jan 2024 --> Feb 2025
    Trial completion • Enrollment change • Trial completion date • Trial primary completion date
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    KRAS (KRAS proto-oncogene GTPase)
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    KRAS mutation • KRAS G12C • KRAS G12
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    Erbitux (cetuximab) • Airuikai (glecirasib)
    12d
    JAB-21822 Combined With Chemotherapy and Bevacizumab in Second-line KRAS G12C CRC (clinicaltrials.gov)
    P1, N=30, Active, not recruiting, Jian Li | Recruiting --> Active, not recruiting | Phase classification: P2 --> P1 | Trial primary completion date: Jun 2026 --> Mar 2026
    Enrollment closed • Phase classification • Trial primary completion date
    |
    KRAS (KRAS proto-oncogene GTPase)
    |
    KRAS mutation • KRAS G12C • KRAS G12
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    Avastin (bevacizumab) • 5-fluorouracil • irinotecan • leucovorin calcium • Airuikai (glecirasib)
    2ms
    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. (PubMed, Lancet Gastroenterol Hepatol)
    Glecirasib monotherapy and its combination with cetuximab represent potential treatment options for patients with advanced, refractory colorectal cancer harbouring KRASG12C mutations. The promising efficacy and safety support further exploration of glecirasib-based combinations in earlier lines of treatment.
    P1/2 data • Journal
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    KRAS (KRAS proto-oncogene GTPase)
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    KRAS mutation • KRAS G12C • KRAS G12
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    Erbitux (cetuximab) • Airuikai (glecirasib)
    2ms
    Glecirasib plus sitneprotafib in patients with KRASG12C-mutated non-small-cell lung cancer in China: an open-label, multicentre, single-arm, phase 1/2a trial. (PubMed, Lancet Respir Med)
    Glecirasib combined with sitneprotafib showed promising efficacy and manageable safety in patients with advanced KRASG12C -mutated NSCLC, particularly among those who had not received previous treatment. These findings support the evaluation of this combination in a phase 3 trial comparing this chemotherapy-free regimen to current standard of care in this patient group.
    P1/2 data • Journal
    |
    KRAS (KRAS proto-oncogene GTPase)
    |
    KRAS mutation • KRAS G12C • KRAS G12
    |
    Airuikai (glecirasib) • sitneprotafib (JAB-3312)
    3ms
    Advances in Diagnosis and Targeted Therapy of KRASG12C Mutant Non-small Cell Lung Cancer (PubMed, Zhongguo Fei Ai Za Zhi)
    In targeted therapies, KRASG12C targeted drugs, including Sotorasib, Adagrasib, Fulzerasib, Garsorasib, and Glecirasib, have demonstrated certain therapeutic efficacies in clinical trials and have obtained marketing approval. To tackle drug resistance and enhance patient's prognoses, combination therapeutic strategies that integrate targeted agents with chemotherapy, immune checkpoint inhibitors, Src homology region 2 domain-containing phosphatase 2 (SHP2) inhibitors, and epidermal growth factor receptor (EGFR) monoclonal antibodies have emerged. This paper systematically reviews the advancements in the diagnosis and targeted therapy of NSCLC with KRASG12C mutation, aiming to offer a reference for the selection of clinical treatment regimens and subsequent research..
    Review • Journal • IO biomarker
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    EGFR (Epidermal growth factor receptor) • KRAS (KRAS proto-oncogene GTPase)
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    KRAS mutation • KRAS G12C • KRAS G12
    |
    Lumakras (sotorasib) • Krazati (adagrasib) • Anfangning (garsorasib) • Airuikai (glecirasib) • Dupert (fulzerasib)
    4ms
    Efficacy and safety of glecirasib in solid tumors with KRAS G12C mutation: A pooled analysis of two phase I/II trials. (PubMed, Cancer Commun (Lond))
    Glecirasib showed promising efficacy and was well tolerated in patients with PDAC and other advanced solid tumors (beyond NSCLC and CRC), warranting further expedited clinical development in this patient population.
    P1/2 data • Retrospective data • Journal
    |
    KRAS (KRAS proto-oncogene GTPase)
    |
    KRAS mutation • KRAS G12C • KRAS G12
    |
    Airuikai (glecirasib)
    4ms
    A Phase 2 Clinical Study of Combination Therapy With ABSK043 and Glecirasib (clinicaltrials.gov)
    P2, N=86, Not yet recruiting, Abbisko Therapeutics Co, Ltd
    New P2 trial
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    Airuikai (glecirasib) • ABSK043
    6ms
    A Phase II Study Evaluating JAB-21822 Monotherapy in Adult Patients With Pancreatic Cancer and Other Solid Tumors Harboring the KRAS p.G12C Mutation. (clinicaltrials.gov)
    P2, N=88, Recruiting, Allist Pharmaceuticals, Inc. | Trial completion date: Nov 2025 --> Dec 2027 | Trial primary completion date: May 2025 --> Dec 2026
    Trial completion date • Trial primary completion date
    |
    KRAS (KRAS proto-oncogene GTPase) • MSI (Microsatellite instability) • CA 19-9 (Cancer antigen 19-9)
    |
    KRAS mutation • MSI-H/dMMR • KRAS G12C • KRAS G12
    |
    Airuikai (glecirasib)
    9ms
    JAB-3312, a Potent Allosteric SHP2 Inhibitor that Enhances the Efficacy of RTK/RAS/MAPK and PD-1 Blockade Therapies. (PubMed, Clin Cancer Res)
    JAB-3312 in combination with RTK/RAS/MAPK or PD-1 blockage therapies is a promising strategy that warrants further clinical investigation.
    Journal • PD(L)-1 Biomarker • IO biomarker
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    EGFR (Epidermal growth factor receptor) • KRAS (KRAS proto-oncogene GTPase)
    |
    KRAS mutation
    |
    Tagrisso (osimertinib) • Airuikai (glecirasib) • sitneprotafib (JAB-3312)
    9ms
    Glecirasib, a potent and selective covalent KRAS G12C inhibitor exhibiting synergism with cetuximab or SHP2 inhibitor JAB-3312. (PubMed, Cancer Res Commun)
    Glecirasib could effectively inhibit HRAS G12C, NRAS G12C, and several G12C-inclusive KRAS double mutants that showed resistance to adagrasib. A new drug application for glecirasib has been submitted in China, seeking approval for the treatment of non-small cell lung cancer, supported by a pivotal phase 2 single-arm study (NCT05009329). Additionally, glecirasib is being explored in clinical trials in combination with cetuximab (phase 2, NCT05194995) and JAB-3312 (phase 3, NCT06416410).
    Journal
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    EGFR (Epidermal growth factor receptor) • KRAS (KRAS proto-oncogene GTPase) • NRAS (Neuroblastoma RAS viral oncogene homolog) • HRAS (Harvey rat sarcoma viral oncogene homolog)
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    KRAS wild-type • RAS wild-type • NRAS wild-type • NRAS G12
    |
    Erbitux (cetuximab) • Krazati (adagrasib) • Airuikai (glecirasib) • sitneprotafib (JAB-3312)
    10ms
    A Study of JAB-21822 in Advanced or Metastatic NSCLC With KRAS p.G12C and STK11 Co-mutation and Wild-type KEAP1 (clinicaltrials.gov)
    P1/2, N=104, Recruiting, Allist Pharmaceuticals, Inc. | Trial primary completion date: Dec 2023 --> Feb 2026
    Trial primary completion date
    |
    KRAS (KRAS proto-oncogene GTPase) • STK11 (Serine/threonine kinase 11) • KEAP1 (Kelch Like ECH Associated Protein 1)
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    KRAS mutation • KRAS G12C • STK11 mutation • KEAP1 mutation • KRAS G12
    |
    Airuikai (glecirasib)