[Translation] An open-label, multicenter, dose-escalation and dose-expansion Phase I clinical study to evaluate the safety, tolerability, pharmacokinetic characteristics and efficacy of NC18 in patients with HER2-positive or HER2-expressing advanced solid tumors

（1）主要目的：评估NC18在HER2阳性或表达的晚期实体瘤患者中的安全性和耐受性，确定NC18使用的最大耐受剂量（MTD）和II期推荐剂量（RP2D）。（2）次要目的：评估NC18的药代动力学（PK）特征、免疫原性和有效性。

[Translation]

(1) Primary objective: To evaluate the safety and tolerability of NC18 in patients with HER2-positive or HER2-expressing advanced solid tumors, and to determine the maximum tolerated dose (MTD) and phase II recommended dose (RP2D) of NC18. (2) Secondary objective: To evaluate the pharmacokinetic (PK) characteristics, immunogenicity and efficacy of NC18.

Start Date25 Jun 2024

Sponsor / Collaborator

Nuo Ling Sheng Wu Yi Yao Ke Ji （ Hang Zhou ） You Xian Gong Si

100 Clinical Results associated with NC-18

100 Translational Medicine associated with NC-18

100 Patents (Medical) associated with NC-18

Literatures (Medical) associated with NC-18

01 Apr 2013·Diagnostic Microbiology and Infectious DiseaseQ4 · MEDICINE

Emergence of blaNDM-1 among Klebsiella pneumoniae ST15 and novel ST1031 clinical isolates in China

Q4 · MEDICINE

Article

Author: Zhang, Bailing ; Pan, Jingye ; Wang, Liangxing ; Tu, Jinjing ; Hu, Longhua ; Xu, Yuanyuan ; Yu, Fangyou ; Hu, Xiaoyan ; Parsons, Chris ; Zhong, Qiaoshi ; Qin, Zhiqiang

The emergence of NDM-1 has become established as a major public health threat and represents a new and major challenge in the treatment of infectious diseases. A total of 39 carbapenem-resistant Enterobacteriaceae isolates collected from patients receiving care at 5 teaching hospitals in Jiangxi province, central China, were analyzed for carriage of resistance genes, including bla(NDM-1). Two carbapenem-resistant Klebsiella pneumoniae isolates (NC12 and NC18) were found to harbor bla(NDM-1). In addition to bla(NDM-1), NC12 also carried bla(SHV-1), while NC18 harbored additional resistance genes, including bla(SHV-12), bla(CTX-M-14), armA and bla(TEM-1). NC12 and NC18 belonged to ST15 and novel ST1031 and were clonally unrelated. Carbapenem resistance for NC12 could be transferred to Escherichia coli recipients through conjugation and chemical transformation, while carbapenem resistance for NC18 was only transferred to E. coli recipients by chemical transformation. The EcoR1-digested DNA pattern of plasmids from the transformants of NC12 was identical to that for NC18. Taken together, this is the first report of bla(NDM-1) carriage by K. pneumoniae clinical isolates in mainland China, indicating that bla(NDM-1) is disseminated among Enterobacteriaceae in China. Systemic surveillance should focus on the dissemination of bla(NDM-1) among Gram-negative clinical isolates, especially some major clones, such as K. pneumoniae ST15 which is a major clone among CTX-M-15-producing isolates.

01 Aug 2011·Applied Biochemistry and BiotechnologyQ3 · ENGINEERING & TECHNOLOGY

Enriched Microbial Community in Bioaugmentation of Petroleum-Contaminated Soil in the Presence of Wheat Straw

Q3 · ENGINEERING & TECHNOLOGY

Article

Author: Zuojun Wu ; Diannan Lu ; Zheng Liu ; Liangdong Zou ; Hongjun Dong

The bioaugmentation of petroleum-contaminated soil using Enterobacter cloacae was profiled from the evolution of microbial community, soil dehydrogenase activity, to the degradation of petroleum contaminants. The seeding and proliferation of inoculant and the consequential microbial community were monitored by denaturing gradient gel electrophoresis analysis of the amplification of V3 zone of 16S rDNA. Degradation process kinetics was characterized by the degradation ratio of nC17 to nC18. The dehydrogenase activity was also determined during the degradation process. An abrupt change in the microbial community after inoculation was illustrated as well as successive changes in response to degradation of the petroleum contaminants. Seeding with E. cloacae stimulated the growth of other degrading stains such as Pseudomonas sp. and Rhodothermus sp. The application of wheat straw as a representative lignin waste, at 5% (w/w), induced an increase in the total dehydrogenase activity from 0.50 to 0.79, an increase in the microbial content of 130% for bacteria and 84% for fungi, and an increase of the overall degradation ratio from 44% to 56% after 56 days of treatment. The above mentioned results have provided a microbial ecological insight being essential for the design and implementation of bioaugmentation processes.

01 Sep 2007·Journal of Chromatography AQ2 · CHEMISTRY

Assessment of oil weathering by gas chromatography–mass spectrometry, time warping and principal component analysis

Q2 · CHEMISTRY

Article

Author: Jan Henning Christensen ; Asger B. Hansen ; Rasmus Rørdam Olsen ; Ole Andersen ; Linus Mattias Valdemar Malmquist

Detailed characterization and understanding of oil weathering at the molecular level is an essential part of tiered approaches for forensic oil spill identification, for risk assessment of terrestrial and marine oil spills, and for evaluating effects of bioremediation initiatives. Here, a chemometric-based method is applied to data from two in vitro experiments in order to distinguish the effects of evaporation and dissolution processes on oil composition. The potential of the method for obtaining detailed chemical information of the effects from evaporation and dissolution processes, to determine weathering state and to distinguish between various weathering processes is investigated and discussed. The method is based on comprehensive and objective chromatographic data processing followed by principal component analysis (PCA) of concatenated sections of gas chromatography-mass spectrometry chromatograms containing homologue series of n-alkanes (m/z 85) and alkyltoluenes (m/z 105). The PCA model based solely on in vitro samples and validated by samples from an authentic marine oil spill gives a detailed description of the temporal changes in n-alkane and alkyltoluene compositions. The PCA model is able to distinguish the two physical weathering processes both with respect to removal rate and relative changes. The model shows that evaporation has a large impact on both the alkyltoluenes and on the n-alkanes (e.g., nC-18 is completely removed after 192 days of in vitro evaporation). Dissolution, however, is shown to be a much slower process for weathering of heavy fuel oils with only limited impact on the alkyltoluenes, and no effects on the n-alkane distribution.

100 Deals associated with NC-18

R&D Status

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Indication	Highest Phase	Country/Location	Organization	Date
HER2 Positive Solid Tumors	Phase 1	China	Nuo Ling Sheng Wu Yi Yao Ke Ji （ Hang Zhou ） You Xian Gong Si	25 Jun 2024

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NC18 (ESMO_ASIA2024)	Not Applicable	HER2-positive	-	NC18	yojilzuuif(dzrpnyiwiz) = dzassviera qorlhgoipn (ljtzsxqeby )	-	07 Dec 2024
				Enhertu	yojilzuuif(dzrpnyiwiz) = gergzkljiw qorlhgoipn (ljtzsxqeby )

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