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- ||||| limertinib (ASK120067) / Aosaikang Pharma
Enrollment closed, Trial completion date, Trial primary completion date, Metastases: ASK120067 Versus Gefitinib as First-line Treatment for EGFRm Locally Advanced or Metastatic NSCLC (clinicaltrials.gov) - Jun 14, 2024
P3, N=337, Active, not recruiting, Sponsor: Jiangsu Aosaikang Pharmaceutical Co., Ltd.
Recruiting --> Active, not recruiting | Trial completion date: Dec 2023 --> Sep 2026 | Trial primary completion date: Mar 2023 --> Mar 2024
- | limertinib (ASK120067) / Aosaikang Pharma
Journal: AM-DMF-SCP: Integrated Single-Cell Proteomics Analysis on an Active Matrix Digital Microfluidic Chip. (Pubmed Central) - May 31, 2024
Applying the AM-DMF-SCP to characterize the proteomes of a third-generation EGFR inhibitor, ASK120067-resistant cells (67R) and their parental NCI-H1975 cells, we observed a potential correlation between elevated VIM expression and 67R resistance, which is consistent with the findings from bulk sample analyses. These results suggest that AM-DMF-SCP is an automated, robust, and sensitive platform for single-cell proteomics and demonstrate the potential for providing valuable insights into cellular mechanisms.
- || limertinib (ASK120067) / Aosaikang Pharma
P1 data, PK/PD data, Journal: Phase 1 study to evaluate the effects of rifampin or itraconazole on the pharmacokinetics of limertinib (ASK120067), a novel mutant-selective inhibitor of the epidermal growth factor receptor in healthy Chinese subjects. (Pubmed Central) - Oct 13, 2023
P1
A single dose of limertinib, administered with or without rifampin or itraconazole, is generally safe and well tolerated in healthy Chinese subjects. www.clinicaltrials.gov identifier is NCT05631678.
- || limertinib (ASK120067) / Aosaikang Pharma
PK/PD data, Journal: Effect of Food on the Pharmacokinetics of Limertinib (ASK120067) and its Main Metabolite in Healthy Chinese Volunteers. (Pubmed Central) - May 24, 2023
Food reduced the rate and increased the extent of limertinib absorption following oral administration. Whether limertinib can be administered regardless of prandial state in patients warrants further investigation of efficacy and safety.
- | limertinib (ASK120067) / Aosaikang Pharma, Tagrisso (osimertinib) / AstraZeneca
Preclinical, Journal: Design, Synthesis, and Evaluation of (R)-8-((Tetrahydrofuran-2-yl)methyl)pyrido[2,3-d]pyrimidin-7-ones as Novel Selective ACK1 Inhibitors to Combat Acquired Resistance to the Third-Generation EGFR Inhibitor. (Pubmed Central) - May 3, 2023
In the ASK120067-resistant lung cancer cell line (67R), 10zi dose-dependently inhibited the phosphorylation of ACK1 and downstream AKT pathway and showed a strong synergistic anti-tumor effect in combination with ASK120067 in vitro. Additionally, 10zi also exhibited reasonable PK profiles with an oral bioavailability of 19.8% at the dose of 10 mg/kg, which provided a promising lead for further development of new anticancer drugs.
- | limertinib (ASK120067) / Aosaikang Pharma
Preclinical, Journal: ASK120067 potently suppresses B-cell or T-cell malignancies in vitro and in vivo by inhibiting BTK and ITK. (Pubmed Central) - Jan 3, 2023
Oral administration of ASK120067 led to significant tumor regression in B-cell lymphoma and T-cell leukemia xenograft models by weakening Bruton's tyrosine kinase and interleukin-2-inducible T cell kinase signaling, respectively. Taken together, our studies demonstrated that ASK120067 exerted preclinical anti-tumor activities against B-/T-cell malignancy by targeting BTK/ITK.
- || limertinib (ASK120067) / Aosaikang Pharma
New P1 trial: Drug-drug Interaction Study Beteewn ASK120067 and Rifampicin or Itraconazole (clinicaltrials.gov) - Nov 30, 2022
P1, N=48, Completed, Sponsor: Jiangsu Aosaikang Pharmaceutical Co., Ltd.
- | Journal: And Still They Come Over Troubled Waters: Can Asia's Third-Generation EGFR Tyrosine Kinase Inhibitors (Furmonertinib, Aumolertinib, Rezivertinib, Limertinib, Befotertinib, SH-1028, and Lazertinib) Affect Global Treatment of EGFR+ NSCLC. (Pubmed Central) - Oct 10, 2022
Taken together, our studies demonstrated that ASK120067 exerted preclinical anti-tumor activities against B-/T-cell malignancy by targeting BTK/ITK. No abstract available
- || limertinib (ASK120067) / Aosaikang Pharma
P2b data, Journal: Efficacy and safety of Limertinib (ASK120067) in patients with locally advanced or metastatic EGFR T790M mutated non-small cell lung cancer: a multicenter, single-arm, phase 2b study. (Pubmed Central) - Oct 6, 2022
P1/2
No abstract available Limertinib (ASK120067) was found to have promising efficacy and an acceptable safety profile for the treatment of patients with locally advanced or metastatic EGFR T790M-mutated NSCLC.
- |||| alflutinib (ASK120067) / Aosaikang Pharma
Clinical: Results from single arm phase II study of the 3rd generation #EGFR TKI limertinib (ASK120067) in EGFR T790M NSCLC now @JTOonline. Study launched in 2019 and included 301 pts. RR 69%, mPFS 11m, mOS not reached, intracranial RR 56%. G3+ diarrhea in 13%. https://t.co/fUB1aiJ8HG (Twitter) - Jun 9, 2022
- |||| limertinib (ASK120067) / Aosaikang Pharma
Trial completion date, Trial primary completion date, Metastases: ASK120067 Versus Gefitinib as First-line Treatment for EGFRm Locally Advanced or Metastatic NSCLC (clinicaltrials.gov) - May 12, 2022
P3, N=334, Recruiting, Sponsor: Jiangsu Aosaikang Pharmaceutical Co., Ltd.
Limertinib (ASK120067) was found to have promising efficacy and an acceptable safety profile for the treatment of patients with locally advanced or metastatic EGFR T790M-mutated NSCLC. Trial completion date: Aug 2021 --> Dec 2023 | Trial primary completion date: Jan 2021 --> Mar 2023
- alflutinib (ASK120067) / Aosaikang Pharma
Efficacy and safety of ASK120067 (limertinib) in patients with locally advanced or metastatic EGFR T790M-mutated non–small cell lung cancer: A multicenter, single-arm, phase IIb study. (Available On Demand; 92) - Apr 28, 2022 - Abstract #ASCO2022ASCO_2870;
P1/2
Trial completion date: Aug 2021 --> Dec 2023 | Trial primary completion date: Jan 2021 --> Mar 2023 ASK120067 demonstrated promising efficacy and an acceptable safety profile for the treatment of patients with locally advanced or metastatic EGFR T790M mutated NSCLC.
- || alflutinib (ASK120067) / Aosaikang Pharma
PK/PD data, Journal: Development of an LC-MS/MS method for quantifying ASK120067, a novel mutant-selective inhibitor of the epidermal growth factor receptor (EGFR) as well as its main metabolite in human plasma and its application in a pharmacokinetic study. (Pubmed Central) - May 15, 2021
Further stabilities for the two analytes and internal standard were also investigated covered the entire experimental process beginning from harvesting whole blood to plasma extraction and analysis. ASK120067 was then administered without issue onto a dose-escalation, the first-in-human Phase I clinical trial in Chinese NSCLC patients to determine the pharmacokinetics of oral ASK120067 administration.
- | alflutinib (ASK120067) / Aosaikang Pharma
Journal: Discovery of a novel third-generation EGFR inhibitor and identification of a potential combination strategy to overcome resistance. (Pubmed Central) - Feb 18, 2021
ASK120067 was then administered without issue onto a dose-escalation, the first-in-human Phase I clinical trial in Chinese NSCLC patients to determine the pharmacokinetics of oral ASK120067 administration. Our results idenfity ASK120067 as a promising third-generation EGFR inhibitor and reveal for the first time that Ack1 activation as a novel resistance mechanism to EGFR inhibitors that guide to potential combination strategy.
- ||| limertinib (ASK120067) / Aosaikang Pharma
Enrollment change, Trial completion date, Trial primary completion date, Metastases: Safety, Tolerability, Pharmacokinetics and Anti-tumour Activity of ASK120067 in Locally Advanced and Metastatic Non Small Cell Lung Cancer (clinicaltrials.gov) - Sep 14, 2020
P1/2, N=507, Recruiting, Sponsor: Jiangsu Aosaikang Pharmaceutical Co., Ltd.
Our results idenfity ASK120067 as a promising third-generation EGFR inhibitor and reveal for the first time that Ack1 activation as a novel resistance mechanism to EGFR inhibitors that guide to potential combination strategy. N=135 --> 507 | Trial completion date: Aug 2020 --> Aug 2021 | Trial primary completion date: Jan 2020 --> Jan 2021
- || limertinib (ASK120067) / Aosaikang Pharma
New P1 trial: Assessing the Pharmacokinetics Effects of Food on ASK120067 in Single Oral Administration in Chinese Healthy Subjects (clinicaltrials.gov) - Apr 23, 2020
P1, N=24, Completed, Sponsor: Jiangsu Aosaikang Pharmaceutical Co., Ltd.
- |||||||||| limertinib (ASK120067) / Aosaikang Pharma
New P3 trial, Metastases: ASK120067 Versus Gefitinib as First-line Treatment for EGFRm Locally Advanced or Metastatic NSCLC (clinicaltrials.gov) - Nov 14, 2019
P3, N=334, Recruiting, Sponsor: Jiangsu Aosaikang Pharmaceutical Co., Ltd.
- | limertinib (ASK120067) / Aosaikang Pharma
Trial primary completion date, Metastases: Safety, Tolerability, Pharmacokinetics and Anti-tumour Activity of ASK120067 in Locally Advanced and Metastatic Non Small Cell Lung Cancer (clinicaltrials.gov) - Oct 1, 2019
P1/2, N=135, Recruiting, Sponsor: Jiangsu Aosaikang Pharmaceutical Co., Ltd.
N=135 --> 507 | Trial completion date: Aug 2020 --> Aug 2021 | Trial primary completion date: Jan 2020 --> Jan 2021 Trial primary completion date: Aug 2019 --> Jan 2020
- ||||| limertinib (ASK120067) / Aosaikang Pharma
New P1/2 trial, Metastases: Safety, Tolerability, Pharmacokinetics and Anti-tumour Activity of ASK120067 in Locally Advanced and Metastatic Non Small Cell Lung Cancer (clinicaltrials.gov) - Sep 9, 2019
P1/2, N=135, Recruiting, Sponsor: Jiangsu Aosaikang Pharmaceutical Co., Ltd.