Evidence map›Paper›PMID 41037823›Full record

Trial reportCancer communications (London, England)2025

Efficacy and safety of glecirasib in solid tumors with KRAS G12C mutation: A pooled analysis of two phase I/II trials.

Jian Li, Ting Deng, Yanhong Gu, Antonio Calles Blanco, Zhihua Li, Chunmei Bai, Lin Wu, Jing Huang, Xingya Li, Yu Yao and 22 more

2 registry-linked trialsAbstract readClinical Trial, Phase IClinical Trial, Phase II
In one paragraph

Trial report in Cancer communications (London, England), 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 13 papers.

0numbers the graph read from it
0cells of the map it votes in
13citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT05002270 phase1 / phase2completednot on this map

A Phase 1/2, Multi-Center, Open-Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Evidence of Antitumor Activity of JAB-21822 Monotherapy and Combination Therapy in Adult Patients With Advanced Solid Tumors Harboring KRAS G12C Mutation

TypeinterventionalSponsorJacobio Pharmaceuticals Co., Ltd.Ran2021 to 2025Enrolled29ConditionsAdvanced Solid Tumor, NSCLC, CRCArmsJAB-21822 (KRAS G12C inhibitor), Cetuximab (EGFR inhibitor)
NCT05009329 phase1 / phase2active not recruitingnot on this map

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

TypeinterventionalSponsorAllist Pharmaceuticals, Inc.Ran2021 to 2026Enrolled315ConditionsNSCLC, Solid TumorArmsJAB-21822
3 · Its place in the literature

Who cites it

13 citing papers in PubMed.

  1. Trial
  2. Review
  3. RAS-targeted therapies for pancreatic cancer.ESMO gastrointestinal oncology · 2026
    Review
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  5. Article
  6. Review
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

32 authors.

Jian LiDepartment of Gastrointestinal Oncology, Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education/Beijing), Beijing Cancer Hospital, Beijing, P. R. China.ORCID https://orcid.org/0000-0002-9333-3255
Ting DengDepartment of Gastrointestinal Medical Oncology, Tianjin Medical University Cancer Institute & Hospital, Tianjin, P. R. China.
Yanhong GuDepartment of Oncology, The First Affiliated Hospital of Nanjing Medical University, Nanjing, Jiangsu, P. R. China.
Antonio Calles BlancoDepartment of Medical Oncology, Hospital General Universitario Gregorio Marañon, Madrid, Spain.ORCID https://orcid.org/0000-0002-2547-1947
Zhihua LiDepartment of Medical Oncology, Sun Yat-Sen Memorial Hospital, Guangzhou, Guangdong, P. R. China.
Chunmei BaiDepartment of Medical Oncology, Peking Union Medical College Hospital, Beijing, P. R. China.
Lin WuDepartment of Thoracic Medical Oncology, Hunan Cancer Hospital, Changsha, Hunan, P. R. China.ORCID https://orcid.org/0000-0001-7078-7767
Jing HuangDepartment of Medical Oncology, Cancer Hospital Chinese Academy of Medical Sciences, Beijing, P. R. China.
Xingya LiDepartment of Medical Oncology, The First Affiliated Hospital of Zhengzhou University, Zhengzhou, Henan, P. R. China.
Yu YaoDepartment of Medical Oncology, The First Affiliated Hospital of Xi'an Jiaotong University, Xi'an, Shaanxi, P. R. China.
Zhengbo SongDepartment of Chemotherapy, Zhejiang Cancer Hospital, Hangzhou, Zhejiang, P. R. China.ORCID https://orcid.org/0000-0002-4817-7775
Yongsheng LiDepartment of Medical Oncology, Chongqing Cancer Hospital, Chongqing, P. R. China.
Lian LiuDepartment of Medical Oncology, Qilu Hospital of Shandong University, Jinan, Shandong, P. R. China.
Ligang XingDepartment of Radiation Oncology, Shandong Cancer Hospital, Jinan, Shandong, P. R. China.ORCID https://orcid.org/0000-0002-0528-9048
Wenming WuDepartment of Medical Oncology, Peking Union Medical College Hospital, Beijing, P. R. China.
Julia Martínez-PérezDepartment of Medical Oncology, Hospital Universitario Virgen del Rocio - PPDS, Sevilla, Spain.
Ayala HubertSharett Institute of Oncology, Hadassah-Hebrew University Medical Center, Jerusalem, Israel.
Jon ZugazagoitiaDepartment of Medical Oncology, Hospital Universitario 12 de Octubre, Madrid, Spain.
Jian ZhangDepartment of Medical Oncology, Fudan University Shanghai Cancer Center, Shanghai, P. R. China.ORCID https://orcid.org/0000-0002-2167-8385
Yongsheng WangDepartment of Thoracic Oncology, West China Hospital of Sichuan University, Chengdu, Sichuan, P. R. China.
Yanqiu ZhaoDepartment of Medical Oncology, Henan Cancer Hospital, Zhengzhou, Henan, P. R. China.
Guilan WenDepartment of Pulmonary and Critical Care Medicine, The First Affiliated Hospital of Nanchang University, Nanchang, Jiangxi, P. R. China.
Guohao XiaDepartment of Oncology, Jiangsu Cancer Hospital, Nanjing, Jiangsu, P. R. China.
Diansheng ZhongDepartment of Medical Oncology, Tianjin Medical University General Hospital, Tianjin, P. R. China.
Xueqin ChenDepartment of Thoracic Oncology, Hangzhou Cancer Hospital, Hangzhou, Zhejiang, P. R. China.
Kuirong JiangDepartment of Oncology, The First Affiliated Hospital of Nanjing Medical University, Nanjing, Jiangsu, P. R. China.
Andrea Wang-GillamJacobio (US) Pharmaceutical, Inc., Burlington, Massachusetts, USA.
Yuli DingJacobio Pharmaceuticals Co., Ltd., Beijing, P. R. China.
Sumei LiuJacobio Pharmaceuticals Co., Ltd., Beijing, P. R. China.
Zhiyue RaoJacobio Pharmaceuticals Co., Ltd., Beijing, P. R. China.
Xinghu LiuJacobio Pharmaceuticals Co., Ltd., Beijing, P. R. China.
Lin ShenDepartment of Gastrointestinal Oncology, Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education/Beijing), Beijing Cancer Hospital, Beijing, P. R. China.

Funding

Jacobio Pharmaceuticals Co., Ltd
6 · The paper itself

Abstract

backgroundGlecirasib, an inhibitor of Kirsten rat sarcoma viral oncogene homolog glycine-to-cysteine substitution at codon 12 (KRAS G12C), has exhibited clinical activity in non-small-cell lung cancer (NSCLC) and colorectal cancer (CRC). Here, we investigated the efficacy and safety of glecirasib in patients with pancreatic ductal adenocarcinoma (PDAC) and other solid tumors (excluding NSCLC and CRC) that rarely harbor the KRAS G12C mutation but for which effective treatment options remain limited.

methodsWe conducted and analyzed two open-label, phase I/II trials in adult patients with KRAS G12C mutant solid tumors, in which glecirasib was administered orally. The two trials had similar eligibility criteria and endpoints but differed in the regions of patient recruitment. We performed a pooled analysis of all patients, excluding NSCLC and CRC, from both trials. The primary endpoint in the pooled population was objective response rate (ORR). Efficacy and safety were assessed in patients who received at least one dose of glecirasib.

resultsAs of June 30, 2024, the pooled analysis included 54 patients who were treated with glecirasib: 32 PDACs, 8 biliary tract cancers (BTCs), 4 small intestinal cancers, 3 gastric cancers, 2 appendiceal cancers, and 5 other tumors. At baseline, 24 received ≥ two prior lines of systemic therapy. Of the 53 efficacy-evaluable patients, the confirmed ORR was 50.9% (95% confidence interval [CI], 36.8%-64.9%), with an ORR of 46.9% (95% CI, 29.1%-65.3%) in PDAC patients. Among other solid tumors, ORR was 71.4% (5/7) in BTC, 100% (4/4) in small intestinal cancer, and 66.7% (2/3) in gastric cancer. Median progression-free survival and median overall survival were 6.9 and 10.8 months, respectively, in the overall population, and 5.5 and 10.8 months, respectively, in patients with PDAC. Treatment-related adverse events (TRAEs) of any grade occurred in 94.4% patients, with grade ≥ 3 TRAEs in 27.8%. No fatal TRAEs or TRAEs leading to treatment discontinuation occurred.

conclusionsGlecirasib 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.

trial registrationClinicalTrials.gov identifier: NCT05009329 and NCT05002270.

Indexed as

NeoplasmsProto-Oncogene Proteins p21(ras)AdultAgedAged, 80 and overFemaleHumansMaleMiddle AgedMutationPancreatic NeoplasmsTreatment OutcomeKRAS protein, humanProto-Oncogene Proteins p21(ras)biliary tract cancerglecirasibJAB‐21822KRAS G12Cpancreatic cancersmall intestinal cancer

Identifiers

PMID41037823
PMCPMC12629856

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.