[Translation] An open, multicenter, Phase I clinical trial to evaluate the safety, tolerability, pharmacokinetic characteristics and preliminary efficacy of ASKC202 tablets or ASK120067 tablets in patients with advanced solid tumors

主要目的评价ASKC202片单、多次给药在晚期实体瘤患者中的安全性和耐受性，确定 ASKC202片的剂量限制性毒性（DLT）和最大耐受剂量（MTD）。评价ASKC202片联合ASK120067片在局部晚期或转移性非小细胞肺癌（NSCLC）患者中的安全性和耐受性，确定ASKC202 片联合 ASK120067片的剂量限制性毒性（DLT）和最大耐受剂量（MTD）。次要目的评价ASKC202 片在晚期实体瘤患者中的药代动力学特征；评价ASKC202片在晚期实体瘤患者中的初步抗肿瘤疗效，为确定后续临床研究给药方案提供依据。评价ASKC202片联合ASK120067片在局部晚期或转移性NSCLC患者中的药代动力学特征；评价ASKC202片联合ASK120067片在局部晚期或转移性NSCLC患者中的初步抗肿瘤疗效，为确定后续临床研究给药方案提供依据。

[Translation]

Main purpose To evaluate the safety and tolerability of single and multiple administrations of ASKC202 tablets in patients with advanced solid tumors, and to determine the dose-limiting toxicity (DLT) and maximum tolerated dose (MTD) of ASKC202 tablets. To evaluate the safety and tolerability of ASKC202 tablets combined with ASK120067 tablets in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC), and to determine the dose-limiting toxicity (DLT) and maximum tolerated dose (MTD) of ASKC202 tablets combined with ASK120067 tablets. Secondary purpose To evaluate the pharmacokinetic characteristics of ASKC202 tablets in patients with advanced solid tumors; to evaluate the preliminary anti-tumor efficacy of ASKC202 tablets in patients with advanced solid tumors, and to provide a basis for determining the dosing regimen for subsequent clinical studies. To evaluate the pharmacokinetic characteristics of ASKC202 tablets combined with ASK120067 tablets in patients with locally advanced or metastatic NSCLC; to evaluate the preliminary anti-tumor efficacy of ASKC202 tablets combined with ASK120067 tablets in patients with locally advanced or metastatic NSCLC, and to provide a basis for determining the dosing regimen for subsequent clinical studies.

Start Date02 Aug 2022

Sponsor / Collaborator

Jiangsu Aosaikang Pharmaceutical Co. Ltd.

NCT05631678 / CompletedPhase 1

An Open-lable, Two- Period, Single-sequence, Self-controlled Study to Evaluate the Effect of Oral Rifampicin or Itraconazole on the Pharmacokinetics of ASK120067 Tablets

To evaluate the effects of oral administration rifampicin or itraconazole capsules on the pharmacokinetics of ASK120067 and its metabolite CCB4580030 in healthy subjects.
To evaluate the safety of ASK120067 tablets or combination with rifampicin capsules or itraconazole capsules in healthy subjects.

Start Date06 Jun 2022

Sponsor / Collaborator

Jiangsu Aosaikang Pharmaceutical Co. Ltd.

CTR20221327 / CompletedPhase 1

开放、两周期、单序列、自身对照研究设计，评价口服利福平或伊曲康唑对ASK120067片药代动力学的影响

[Translation] An open-label, two-period, single-sequence, self-controlled study design to evaluate the effect of oral rifampicin or itraconazole on the pharmacokinetics of ASK120067 tablets

主要目的：评价健康受试者口服CYP3A4强诱导剂利福平胶囊、强抑制剂伊曲康唑胶囊对ASK120067及其代谢产物CCB4580030药代动力学的影响；次要目的：评价健康受试者单剂量口服ASK120067片及与利福平胶囊、伊曲康唑胶囊联合用药的安全性。

[Translation]

Primary objective: To evaluate the effects of oral administration of rifampicin capsules, a strong CYP3A4 inducer, and itraconazole capsules, a strong inhibitor, on the pharmacokinetics of ASK120067 and its metabolite CCB4580030 in healthy subjects; Secondary objective: To evaluate the safety of single-dose oral administration of ASK120067 tablets and its combination with rifampicin capsules and itraconazole capsules in healthy subjects.

Start Date06 Jun 2022

Sponsor / Collaborator

Gibh

[+2]

100 Clinical Results associated with Limertinib

100 Translational Medicine associated with Limertinib

100 Patents (Medical) associated with Limertinib

Literatures (Medical) associated with Limertinib

27 May 2024·JACS Au

AM-DMF-SCP: Integrated Single-Cell Proteomics Analysis on an Active Matrix Digital Microfluidic Chip

Article

Author: Feng, Fang ; Zhou, Hu ; Chen, Hongxu ; Xie, Hua ; Chen, Yimin ; Jin, Kai ; Wang, Yuqiu ; Hu, Siyi ; Yang, Zhicheng ; Pan, Zilu ; Ma, Hanbin ; Shi, Mude ; Liu, Qian

Single-cell proteomics offers unparalleled insights into cellular diversity and molecular mechanisms, enabling a deeper understanding of complex biological processes at the individual cell level. Here, we develop an integrated sample processing on an active-matrix digital microfluidic chip for single-cell proteomics (AM-DMF-SCP). Employing the AM-DMF-SCP approach and data-independent acquisition (DIA), we identify an average of 2258 protein groups in single HeLa cells within 15 min of the liquid chromatography gradient. We performed comparative analyses of three tumor cell lines: HeLa, A549, and HepG2, and machine learning was utilized to identify the unique features of these cell lines. 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.

01 Oct 2023·Clinical pharmacology in drug development

Effect of Food on the Pharmacokinetics of Limertinib (ASK120067) and its Main Metabolite in Healthy Chinese Volunteers.

Article

Author: Jiang, Bo ; Guo, Haifang ; Chen, Wenjun ; Ruan, Zourong ; Yang, Dandan ; Lou, Honggang ; Jiang, Qianqian

Limertinib (ASK120067) is a newly developed third-generation epidermal growth factor receptor tyrosine kinase inhibitor. This phase I, open-label, 2-period crossover study was conducted to evaluate the effect of food on the pharmacokinetics (PK) of limertinib and its active metabolite CCB4580030 in Chinese healthy volunteers (HVs). HVs were randomly assigned (1:1) to receive a single dose of limertinib (160 mg) under the fasted state in period 1 and fed condition in period 2, or vice versa. Twenty-four HVs were enrolled, and 20 HVs completed both study periods. PK were assessed before dosing and ≤72 hours after dosing. PK parameters were analyzed by a noncompartmental method. Limertinib was absorbed faster in the fasted state compared with the fed state. The geometric mean ratios (fed/fast) of maximum concentration, area under the plasma concentration-time curve from time 0 to the last quantifiable concentration, and area under the plasma concentration-time curve from time 0 to infinity for ASK120067 were 145.5%, 145.4%, and 141.9%, respectively. Geometric mean ratios of the PK parameters of CCB4580030 were >125.00% and 90% confidence intervals were outside the preset bioequivalent range. Safety profiles were similar in both prandial states, and limertinib was well tolerated. 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.

02 Sep 2023·Expert opinion on drug metabolism & toxicology

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

Article

Author: Yang, Yuanxun ; Zhao, Yu ; Huang, Lei ; Liu, Ming ; Cao, Bei ; Li, Juan ; Ma, Tingting ; Lin, Hui ; Guo, Haifang ; Geng, Yan

BACKGROUND:

Limertinib is a novel mutant-selective and irreversible inhibitor of the epidermal growth factor receptor under development. A phase 1 open, two-period, single-sequence, self-controlled, two-part study was initiated to characterize the effects of a strong CYP3A4 inducer (rifampin) or inhibitor (itraconazole) on the pharmacokinetics of limertinib.

RESEARCH DESIGN AND METHODS:

Twenty-four healthy subjects in each part received a single dose of limertinib alone (160 mg, Part A; 80 mg, Part B) and with multiple doses of rifampin 600 mg once daily (Part A) or itraconazole 200 mg twice daily (Part B).

RESULTS:

Coadministration of rifampin decreased exposure (area under the plasma concentration-time curve from time 0 to infinity, AUC_0-inf) of limertinib and its active metabolite CCB4580030 by 87.86% (geometric least-squares mean [GLSM] ratio, 12.14%; 90% confidence interval [CI], 9.89-14.92) and 66.82% (GLSM ratio, 33.18%; 90% CI, 27.72-39.72), respectively. Coadministration of itraconazole increased the AUC_0-inf of limertinib by 289.8% (GLSM ratio, 389.8%; 90% CI, 334.07-454.82), but decreased that of CCB4580030 by 35.96% (GLSM ratio, 64.04%; 90% CI, 50.78-80.77).

CONCLUSIONS:

Our study demonstrates that the concomitant use of limertinib with strong CYP3A inducers or inhibitors is not recommended. A single dose of limertinib, administered with or without rifampin or itraconazole, is generally safe and well tolerated in healthy Chinese subjects.

CLINICAL TRIAL REGISTRATION:

www.clinicaltrials.gov identifier is NCT05631678.

News (Medical) associated with Limertinib

09 Oct 2024

·www.pharmaceutical-technology.com

MSD ventures into fibroblast therapies with $1.9bn deal with Mestag

Mestag’s pipeline consists of antibody therapies based on fibroblast-immune interactions as a treatment for cancer and inflammatory diseases. Image credit: Sergiy Palamarchuk / Shutterstock. MSD ( Merck & Co) has signed a license and collaboration agreement with Mestag Therapeutics to develop new fibroblast therapies for inflammatory diseases – a deal potentially worth $1.9bn The companies did not disclose the particulars of the deal, noting that the agreement allows MSD the option to get exclusive development and marketing licences to “a prespecified number of potential targets.” The UK-based biotech in return will receive an upfront payment, and access fees and will be in line to receive option fees and “downstream payments”. Fibroblasts form the connective tissue and are responsible for synthesising extracellular matrix components and collagen, the structural framework of the body. They also play an important role in wound healing, inflammation, and tissue repair. Mestag’s pipeline consists of antibody therapies based on fibroblast-immune interactions as a treatment for cancer and inflammatory diseases. The company’s lead candidate, MST-0300, is a bispecific antibody. The therapy targets lymphotoxin beta receptor (LTBR) in the tumour on co-engagement of fibroblast activation protein (FAP), a tumour-specific marker expressed by cancer-associated fibroblasts, to induce the formation of tertiary lymphoid structures (TLSs) in solid tumours. The presence of these TLSs can be predictive of improved patient outcomes and better therapeutic response. Mestag plans to file an investigational new drug (IND) application in the second half of 2025. Another preclinical candidate in the company’s pipeline is M402, a stromal checkpoint agonist antibody. The therapy is designed to inhibit specific immune cell populations, including myeloid cells. Mestag states that M402 has the “potential to benefit patients across inflammatory diseases including rheumatoid arthritis, lupus, Sjogren’s, graft-versus-host disease and others.” See Also: Clinical Dose Companies in Contract Manufacturing for the Pharmaceutical Industry Innovent and ASK Pharm to commercialise limertinib for lung cancer MSD has been steadily investing in expanding its antibody therapies pipeline. In August, the company acquired Curon Biopharmaceutical , a Chinese biopharmaceutical company specialising in developing bispecific antibodies. The deal is worth approximately $1.3bn in upfront and milestone-based payments. Mestag had previously collaborated with Johnson & Johnson (J&J) in 2021. The licensing agreement allowed J&J the option of an exclusive license to develop and commercialise up to two therapies for the treatment of inflammatory disease.

License out/inADCAcquisitionImmunotherapy

09 Oct 2024

·www.pharmaceutical-technology.com

FDA declines to approve Zealand Pharma’s hypoglycaemia therapy in infants

The company had sought approval for dasiglucagon for the treatment and prevention of hypoglycaemia in infants with congenital hyperinsulinism. Credit: Gorodenkoff/Shutterstock. The US Food and Drug Administration (FDA) has issued a complete response letter (CRL) to Zealand Pharma , declining the approval of dasiglucagon for the treatment and prevention of hypoglycaemia in infants with congenital hyperinsulinism (CHI). The CRL, which pertains to Part 1 of the new drug application (NDA) for patients aged seven days and older, cites the need for a reinspection at a third-party manufacturing facility. This regulatory decision is linked to the timing of a reinspection at a contract manufacturing site that concluded in August/September 2024. The facility, responsible for producing dasiglucagon, has not received its inspection classification post-reinspection. Although a previous inspection had identified deficiencies, they were not related to dasiglucagon and had been addressed by the time of the latest reinspection. See Also: Clinical Dose Companies in Contract Manufacturing for the Pharmaceutical Industry Innovent and ASK Pharm to commercialise limertinib for lung cancer The CRL did not raise any concerns regarding the clinical data or the safety profile of dasiglucagon. Zealand Pharma’s NDA for dasiglucagon is currently undergoing a two-part regulatory review. While Part 1 involved dosing for up to three weeks, Part 2 will cover usage beyond that period. The FDA has requested additional analyses from existing continuous glucose monitoring data collected during Phase III clinical trials to support the use of dasiglucagon in CHI for extended periods. Zealand Pharma anticipates submitting the required data by the end of 2024. Zealand Pharma chief medical officer David Kendall said: “We at Zealand Pharma are acutely aware of the significant unmet medical need for newborns and children with congenital hyperinsulinism who have either no or very limited treatment options today. “We are committed to working with the FDA and our third-party manufacturing partner to bring dasiglucagon to patients living with this devastating disease in the months ahead.”

NDAPhase 3

08 Oct 2024

·www.prnewswire.com

Innovent and Ask Pharm Announce Strategic Collaboration for Limertinib, a Third-generation EGFR TKI for the Treatment of Lung Cancer

SAN FRANCISCO and SUZHOU, China, Oct. 7, 2024 /PRNewswire/ -- Innovent Biologics, Inc. ("Innovent") (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high-quality medicines for the treatment of oncologic, autoimmune, cardiovascular and metabolic, ophthalmologic and other major diseases, and Jiangsu Aosaikang Pharmaceutical Co. Ltd. (ASK Pharm, 002755.SZ), announced that the two parties have entered into a strategic collaboration regarding limertinib, a third-generation epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI) for the treatment of lung cancer. Under the agreement, Innovent will obtain the exclusive commercialization rights for limertinib in mainland China, and will be entitled to receive a commercialization service fee based on the product's net sales in the region. Ask-Pharm as the MAH holder, will be responsible for the production and commercial supply of limertinib and will be eligible for upfront, regulatory and sales milestone payments. Limertinib is an orally administrated, third-generation novel EGFR TKI with proprietary rights. Two New Drug Applications (NDAs) for limertinib have been accepted and are under review by China's National Drug Administration (NMPA): (1) for the treatment of adult patients with locally advanced or metastatic EGFR T790M mutation-positive NSCLC, confirmed by a validated diagnostic test, whose disease has progressed after EGFR TKI therapy; and (2) for the first-line treatment of adult patients with locally advanced or metastatic NSCLC with EGFR exon 19 deletions or exon 21 L858R mutations. In a multi-center, randomized, double-blind, controlled Phase 3 clinical trial, limertinib's efficacy and safety were compared with gefitinib in the first-line treatment of patients with locally advanced or metastatic NSCLC with EGFR mutations. The Phase 3 clinical trial met its primary endpoint, and detailed data and analysis will be presented at future academic conferences or published in academic journals. Previously, results of limertinib from a Phase 2b clinical study were presented in a poster session at the 2022 American Society of Clinical Oncology (ASCO) Annual Meeting. Dr. Michael Yu, Founder, Chairman and CEO of Innovent, stated: "We are delighted to enter this strategic collaboration with ASK Pharm, one of the most innovative biopharmaceutical companies in China, which will further strengthen Innovent's leadership in oncology. Together with our partners, Innovent has successfully developed a series of high-quality innovative medicines for lung cancer treatments, including TYVYT® (sintilimab Injection), BYVASDA® (bevacizumab Injection), Retsevmo® (selpercatinib), Dupert® (fulzerasib) and Taletrectinib (ROS1 Inhibitor, NDA under review). The addition of limertinib will offer a valuable new treatment option for Chinese patients with EGFR-mutated lung cancer. Innovent remains committed to investing in innovation and collaborative partnerships, aiming to enhancing the accessibility and affordability of innovative therapies in China to benefit even more patients." Mr. Jingfei Ma, Director and General Manager of ASK Pharm, stated: "We are pleased to form a strategic partnership with Innovent Biologics. Oncology is one of the four core areas of focus for ASK Pharm, and our oncology product line spans chemotherapy drugs, small molecule targeted drugs, and biologics. Limertinib, ASK Pharm's first innovative drug, targets the cancer type with the highest incidence and mortality rates in China. Focused on addressing the most common mutations in lung cancer, Ask-Pharm is committed to providing effective drugs for the vast number of patients with EGFR-mutated lung cancer. Innovent has a rich product pipeline in the field of lung cancer, which can form advantageous synergies with limertinib. In addition, with Innovent's professional and efficient marketing team and proven commercialization capabilities, we are confident that this cooperation will help limertinib to fully realize its clinical value, so that more patients can benefit from it." About EGFR mutation-positive non-small-cell lung cancer (NSCLC) Lung cancer is the leading cause of cancer-related death and the second more common cancer worldwide. In China, it has both the highest incidence and mortality rates among malignant tumors. Non-small cell lung cancer (NSCLC) accounts for approximately 80% to 85% of all lung cancers, and approximately 70% of NSCLC patients are diagnosed with locally advanced or metastatic disease that is not eligible to surgical resection. EGFR is the most frequent driver mutation in NSCLC, with 30% to 50% of Asian NSCLC patients having EGFR mutations. EGFR-TKIs are the recommended first-line standard of care for this group, with third-generation EGFR inhibitors offering the broadest applicability. About Limertinib Limertinib is an orally-administrated, third-generation EGFR TKI with proprietary rights, classified as a new molecular entity. Two New Drug Applications (NDAs) of limertinib are currently under review by China's National Drug Administration (NMPA): (1) for the treatment of adult patients with locally advanced or metastatic EGFR T790M mutation-positive NSCLC, confirmed by an approved test, whose disease has progressed following EGFR TKI therapy; and (2) for the first-line treatment of adult patients with locally advanced or metastatic NSCLC with EGFR exon 19 deletions or exon 21 L858R mutations. In a multi-center, randomized, double-blind, controlled Phase 3 clinical trial, the efficacy and safety of limertinib were compared to gefitinib in the first-line treatment of patients with locally advanced or metastatic NSCLC harboring EGFR mutations. The Phase 3 clinical trial met its primary endpoint, and the results will be presented at future academic conferences or published in academic journals. Results from a Phase 2b clinical study were presented in a poster session at the 2022 American Society of Clinical Oncology (ASCO) Annual Meeting. In October 2024, Innovent and ASK Pharm entered into a strategic collaboration and license agreement regarding limertinib in mainland China. About Innovent Innovent is a leading biopharmaceutical company founded in 2011 with the mission to empower patients worldwide with affordable, high-quality biopharmaceuticals. The company discovers, develops, manufactures and commercializes innovative medicines that target some of the most intractable diseases. Its pioneering therapies treat cancer, cardiovascular and metabolic, autoimmune and eye diseases. Innovent has launched 11 products in the market. It has 5 new drug applications (NDA) under regulatory review, 3 assets in Phase III or pivotal clinical trials and 18 more molecules in early clinical stage. Innovent partners with over 30 global healthcare companies, including Eli Lilly, Sanofi, Incyte, Adimab, LG Chem and MD Anderson Cancer Center. Guided by the motto, "Start with Integrity, Succeed through Action," Innovent maintains the highest standard of industry practices and works collaboratively to advance the biopharmaceutical industry so that first-rate pharmaceutical drugs can become widely accessible. For more information, visit , or follow Innovent on Facebook and LinkedIn. About Jiangsu Aosaikang Pharmaceutical Co. Ltd. (ASK Pharm) Founded in January 2003, Jiangsu Aosaikang Pharmaceutical Co. Ltd. (ASK Pharm) is a research-based pharmaceutical enterprise that integrates and streamlines innovative research and development with manufacture, marketing promotion and sales of proprietary pharmaceuticals, fine chemicals and health-care products. ASK Pharm specializes in digestive disease, multidrug resistant infection, oncology and chronic disease areas. ASK Pharm focuses on the R&D of small-molecule targeted innovative drugs and immuno-oncology biologic drugs. Currently, there are 48 major research projects, including 11 disclosed key projects focused on innovative chemical and biologic drugs. Among these, the innovative anti-tumor drug Limertinib are in the NDA stage, while ASKC109 (maltol iron capsules) and ASKB589 (Claudin18.2 monoclonal antibody) are in Phase III clinical trials. ASK Pharm has Ranked among the top 20 best industrial enterprises in China's pharmaceutical R&D pipeline for 14 consecutive years and it has also received numerous honors such as "Top Ten National R&D Innovators", "Best National Enterprise for Investment", and "National Torch Program High-Tech Enterprises". For more information, visit . Innovent's Forward-Looking Statements This news release may contain certain forward-looking statements that are, by their nature, subject to significant risks and uncertainties. The words "anticipate", "believe", "estimate", "expect", "intend" and similar expressions, as they relate to Innovent, are intended to identify certain of such forward-looking statements. Innovent does not intend to update these forward-looking statements regularly. These forward-looking statements are based on the existing beliefs, assumptions, expectations, estimates, projections and understandings of the management of Innovent with respect to future events at the time these statements are made. These statements are not a guarantee of future developments and are subject to risks, uncertainties and other factors, some of which are beyond Innovent's control and are difficult to predict. Consequently, actual results may differ materially from information contained in the forward-looking statements as a result of future changes or developments in our business, Innovent's competitive environment and political, economic, legal and social conditions. Innovent, the Directors and the employees of Innovent assume (a) no obligation to correct or update the forward-looking statements contained in this site; and (b) no liability in the event that any of the forward-looking statements does not materialize or turn out to be incorrect. SOURCE Innovent Biologics WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Phase 2Phase 3License out/inClinical ResultNDA

100 Deals associated with Limertinib

External Link

KEGG	Wiki	ATC	Drug Bank
-	-	-	DB16087

R&D Status

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
EGFR exon 19 Deletions Mutant Non-small Cell Lung Cancer	NDA/BLA	CN	Jiangsu Aosaikang Pharmaceutical Co. Ltd.	13 Aug 2024
EGFR exon 21 Substitution Mutant Non-small Cell Lung Cancer	NDA/BLA	CN	Jiangsu Aosaikang Pharmaceutical Co. Ltd.	13 Aug 2024
Locally Advanced Lung Non-Small Cell Carcinoma	NDA/BLA	CN	Jiangsu Aosaikang Pharmaceutical Co. Ltd.	16 Nov 2021
EGFR positive non-small cell lung cancer	Phase 3	CN	Gibh	30 Oct 2019
EGFR positive non-small cell lung cancer	Phase 3	CN	Shanghai Institute of Materia Medica Chinese Academy of Sci	30 Oct 2019
EGFR positive non-small cell lung cancer	Phase 3	CN	Jiangsu Aosaikang Pharmaceutical Co. Ltd.	30 Oct 2019
EGFR T790M Mutation Positive Non-Small Cell Lung Carcinoma	Phase 3	CN	Jiangsu Aosaikang Pharmaceutical Co. Ltd.	23 Jul 2019
MET gene amplification Non-small Cell Lung Cancer	IND Approval	CN	Jiangsu Aosaikang Pharmaceutical Co. Ltd.	20 Nov 2023

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03502850 (ASCO2022) Manual	Phase 2	EGFR-mutated non-small Cell Lung Cancer EGFR T790M Mutation	301	Limertinib	sdmdqvrwpw(wwosbzvjpb) = kzecpcjjlv rcbdirycpq (kqgaocyswb, 63.2 - 74.0) View more	Positive	02 Jun 2022
NCT03502850 (ASCO2022) Manual	Phase 2	EGFR-mutated non-small Cell Lung Cancer EGFR T790M Mutation	301	Limertinib (CNS metastases)	sdmdqvrwpw(wwosbzvjpb) = jzawkrmxjt rcbdirycpq (kqgaocyswb, 54.4 - 74.0) View more	Positive	02 Jun 2022
NCT03502850 (Pubmed)	Phase 2	EGFR T790M Mutation Positive Non-Small Cell Lung Carcinoma	301	Limertinib 160 mg	uzmtvellcj(ncjnehlmqf) = fcdlfldxrp btinsrcwre (ziuqtvlstx, 39.7% - 71.5%) View more	Positive	02 Jun 2022

Translational Medicine

Boost your research with our translational medicine data.

view full example data

Deal

Boost your decision using our deal data.

view full example data

Core Patent

Boost your research with our Core Patent data.

view full example data

Clinical Trial

Identify the latest clinical trials across global registries.

view full example data

Approval

Accelerate your research with the latest regulatory approval information.

view full example data

Regulation

Understand key drug designations in just a few clicks with Synapse.

view full example data

Chat with Hiro

Get started for free today!

Accelerate Strategic R&D decision making with Synapse, PatSnap’s AI-powered Connected Innovation Intelligence Platform Built for Life Sciences Professionals.

Start your data trial now!

Synapse data is also accessible to external entities via APIs or data packages. Empower better decisions with the latest in pharmaceutical intelligence.

Bio

Bio Sequences Search & Analysis

Chemical

Chemical Structures Search & Analysis