MET-4(MET-4) - 在研适应症：实体瘤，肿瘤，头颈部鳞状细胞癌_专利_临床

概要

基本信息

药物类型

活菌制剂

别名

MET 4、MET-4

靶点-

作用机制

细菌替代物、微生物调节剂

治疗领域

在研适应症

非在研适应症

原研机构

在研机构

非在研机构-

最高研发阶段临床2/3期

首次获批日期-

最高研发阶段(中国)-

特殊审评-

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关联

3

项与 MET-4 相关的临床试验

NCT05743777 / Withdrawn临床2期IIT

A Phase II Study of PembROlizumab With or Without Microbial EcOsystem ThErapeutic 4 (MET4) in Advanced Head and Neck Squamous Cell Carcinoma

The usual approach for patients who are not in a study is treatment with pembrolizumab, a type of immunotherapy drug. Immunotherapy works by allowing the immune system to detect your cancer and reactivate the immune response. This may help to slow down the growth of cancer and may cause cancer cells to die.

开始日期2023-05-12

申办/合作机构

Canadian Cancer Trials Group

[+1]

NCT03838601 / Active, not recruitingN/AIIT

Role of Microbiome as a Biomarkers in Locoregionally-Advanced Oropharyngeal Squamous Cell Carcinoma 2 (ROMA LA-OPSCC-2)

This is a single-centre feasibility study designed to assess the safety, tolerability and engraftment of MET-4 bacterial strains when given in combination with chemoradiotherapy (CRT). The study will involve a prospective cohort of 30 patients diagnosed with Locoregionally-Advanced Oropharyngeal Squamous Cell Carcinoma (LA-OPSCC) to be treated with CRT as per standard of care at Princess Margaret Cancer Centre. All patients enrolled will receive MET-4 in addition to standard CRT. MET-4 is administered orally as an initial daily loading dose over 2 days followed by a daily maintenance dose of MET-4 and will be administered until week 4 of CRT or unacceptable toxicity whichever occurs earlier and in the absence of criteria to discontinue MET-4. This protocol does not determine eligibility to receive treatment with concurrent CRT. It is anticipated that patient accrual will be completed within 12 months.

开始日期2019-07-02

申办/合作机构

University Health Network

[+1]

NCT03686202 / Active, not recruiting临床2/3期IIT

Feasibility Study of Microbial Ecosystem Therapeutics (MET-4) to Evaluate Effects of Fecal Microbiome in Patients on ImmunOtherapy (MET4-IO)

This study is designed to assess the safety, tolerability and engraftment (cumulative relative abundance) of MET-4 strains when given in combination with immune checkpoint inhibitors (ICIs). There will be a safety cohort (group A) of 5 subjects which will receive MET-4 in addition to standard of care (SOC) ICI. After the safety cohort, 40 patients will be enrolled in group B which will be randomized to MET4 with SOC ICI vs. control group with SOC ICI only. Group C will enroll 20 patients who have already started on SOC ICI and have had first unconfirmed progression of disease and expected to continue with standard ICI treatment. These patients will be randomized to continue receiving standard ICI alone, or SOC ICI with MET4.

开始日期2018-11-30

申办/合作机构

University Health Network

[+1]

100 项与 MET-4 相关的临床结果

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100 项与 MET-4 相关的转化医学

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100 项与 MET-4 相关的专利（医药）

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3

项与 MET-4 相关的文献（医药）

2024-06-29·BRITISH JOURNAL OF CANCER

Prospective manipulation of the gut microbiome with microbial ecosystem therapeutic 4 (MET4) in HPV-related locoregionally-advanced oropharyngeal cancer squamous cell carcinoma (LA-OPSCC) undergoing primary chemoradiation: ROMA2 study

Article

作者: Jennings, Sarah ; Oliva, Marc ; Rooney, Ashley M ; Xu, Wei ; Siu, Lillian L ; Chepeha, Douglas ; Taylor, Rachel ; Weinreb, Ilan ; Nin, Ricard Mesia ; Hansen, Aaron R ; Watson, Geoffrey ; Xu, Minge ; Hosni, Ali ; Hope, Andrew ; Cochrane, Kyla ; Heirali, Alya ; Spreafico, Anna ; Coburn, Bryan ; Perez-Ordonez, Bayardo ; Bratman, Scott V ; Waldron, John

BACKGROUND:

Gut microbiome modulation to boost antitumor immune responses is under investigation.

METHODS:

ROMA-2 evaluated the microbial ecosystem therapeutic (MET)-4 oral consortia, a mixture of cultured human stool-derived immune-responsiveness associated bacteria, given with chemoradiation (CRT) in HPV-related oropharyngeal cancer patients. Co-primary endpoints were safety and changes in stool cumulative MET-4 taxa relative abundance (RA) by 16SRNA sequencing. Stools and plasma were collected pre/post-MET-4 intervention for microbiome and metabolome analysis.

RESULTS:

Twenty-nine patients received ≥1 dose of MET-4 and were evaluable for safety: drug-related adverse events (AEs) occurred in 13/29 patients: all grade 1-2 except one grade 3 (diarrhea). MET-4 was discontinued early in 7/29 patients due to CRT-induced toxicity, and in 1/29 due to MET-4 AEs. Twenty patients were evaluable for ecological endpoints: there was no increase in stool MET-4 RA post-intervention but trended to increase in stage III patients (p = 0.06). MET-4 RA was higher in stage III vs I-II patients at week 4 (p = 0.03) and 2-month follow-up (p = 0.01), which correlated with changes in plasma and stool targeted metabolomics.

CONCLUSIONS:

ROMA-2 did not meet its primary ecologic endpoint, as no engraftment was observed in the overall cohort. Exploratory findings of engraftment in stage III patients warrants further investigation of microbiome interventions in this subgroup.

2015-12-01·Animal nutrition (Zhongguo xu mu shou yi xue hui)1区 · 农林科学

Effects of dietary methionine supplementation on growth performance of cubs, nutrient digestibility, nitrogen metabolism and serum biochemical indicators of female blue foxes (Alopex lagopus)

1区 · 农林科学

ArticleOA

作者: Yang, Fuhe ; Wu, Xuezhuang ; Zhang, Tietao ; Guo, Jungang ; Liu, Zhi ; Cui, Hu ; Gao, Xiuhua

The objective of the present study was to investigate the effects of methionine (Met) supplementation on growth performance of cubs, nutrient digestibility, nitrogen metabolism and serum biochemical parameters of female blue foxes. One hundred primiparous female blue foxes that were similar in breeding date, pedigree, age, and weight were selected for the trial. The foxes were randomly assigned to four groups (n = 25 each group) and fed diets supplemented with Met at 2 (Met2), 4 (Met4), 6 (Met6) and 8 g/kg (Met8), respectively, for 40 days. Our data showed that body weights at 20 and 40 d were significantly higher in the Met4 group than in the Met2 group (P < 0.05). The Met4 group also had the highest apparent digestibility of dry matter and crude protein compared with either the Met2, Met6, or Met8 group (P < 0.05). The serum Met and isoleucine (Ile) concentrations were significantly higher in the Met4 group than in the Met6 or Met8 group (P < 0.05). In summary, these data indicate that supplementary Met improves growth performance of cubs likely due to increased crude protein and dry matter and increased nitrogen retention of female blue foxes. The optimal amount of Met supplementation is 10 g/kg basal diet.

1971-03-01·The Journal of clinical endocrinology and metabolism2区 · 医学

No Interference from Thyroxine Methyl Ester with T₃Determination by Nauman, Nauman and Werner Method

2区 · 医学

Article

作者: Werner, Sidney C. ; Radichevich, Ildiko

K. Sterling (1969) claimed that the Me ester of thyroxine (MeT4) is formed during the determination of total triiodothyronine (T3) in blood by the method of Nauman, et al. (1967).Sterling reported that the formation of MeT4 caused falsely elevated T3 values.This paper reports experiments with authentic MeT4 which indicated that the Rf values of MeT4 and T3 are significantly different on paper chromatograms developed by the descending technique in a tert-amyl alc.-concentrated NH3-H2O (5:1:4) solvent system.MeT4 was completely hydrolyzed during the procedure described by Nauman, et al.Also, MeT4 added to human serum did not cause contamination of the area corresponding to T3 in the paper chromatog. system employed.Therefore, the formation of MeT4 does not interfere with the determination of T3 by the method of Nauman et al.

100 项与 MET-4 相关的药物交易

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研发状态

10 条进展最快的记录,

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适应症	最高研发状态	国家/地区	公司	日期
实体瘤	临床3期	加拿大	Nubiyota LLC	2018-11-30
晚期头颈部鳞状细胞癌	临床2期	-	Nubiyota LLC	2023-05-12
肿瘤	临床1期	美国	Nubiyota LLC	2022-06-15