[Translation] A dose-escalation, open-label Phase I clinical study to evaluate the safety, tolerability, and pharmacokinetic characteristics of NV-A01 in the treatment of patients with advanced malignant solid tumors

评价NV-A01单次与多次瘤内注射给药治疗晚期恶性实体瘤患者的安全性和耐受性，观察NV-A01的剂量限制性毒性（DLT），确定NV-A01的最大耐受剂量（MTD）以及Ⅱ期临床试验推荐剂量（RP2D）。

[Translation]

To evaluate the safety and tolerability of single and multiple intratumoral injections of NV-A01 in the treatment of patients with advanced malignant solid tumors, observe the dose-limiting toxicity (DLT) of NV-A01, and determine the maximum tolerated dose (MTD) of NV-A01 and the recommended dose (RP2D) for Phase II clinical trials.

Start Date-

Sponsor / Collaborator

Nanjing Nuowei Biotechnology Partnership LP

NCT06193538 / RecruitingPhase 1

Clinical Study on the Safety and Effectiveness of NV-A01 in the Treatment of Advanced Glioma Patients

The goal of this clinical trial is to learn about the safety and effectiveness of NV-A01 in the treatment of advanced glioma patients. The main questions it aims to answer are:
The safety of NV-A01 in the treatment of advanced glioblastoma patients.
The effectiveness of NV-A01 in treating patients with advanced glioblastoma.

Start Date14 Sep 2023

Sponsor / Collaborator

Wannan Medical College

100 Clinical Results associated with NV-A01

100 Translational Medicine associated with NV-A01

100 Patents (Medical) associated with NV-A01

Literatures (Medical) associated with NV-A01

01 Jan 2023·Frontiers in immunology

Infant antibody and B-cell responses following confirmed pediatric GII.17 norovirus infections functionally distinguish GII.17 genetic clusters.

Article

Author: Diehl, Sean A ; Mallory, Michael L ; Zepeda, Omar ; Reyes, Yaoska ; Montmayeur, Anna M ; Gonzalez, Fredman ; Bucardo, Filemon ; Vinjé, Jan ; Averill, April M ; Strother, Camilla A ; McElvany, Benjamin D ; Becker-Dreps, Sylvia ; Costantini, Verónica P ; May, Samantha ; Baric, Ralph S ; Brewer-Jensen, Paul D ; Lindesmith, Lisa C

Genogroup II (GII) noroviruses are a major cause of diarrheal disease burden in children in both high- and low-income countries. GII.17 noroviruses are composed of distinct genetic clusters (I, II, IIIa, and IIIb) and have shown potential for replacing historically more prevalent GII.4 strains, but the serological basis for GII.17 antigenic diversity has not been studied in children. Utilizing samples from a birth cohort, we investigated antibody and B-cell responses to GII.17 cluster variants in confirmed GII.17 infections in young children as well as demonstrated that the distinct genetic clusters co-circulate. Polyclonal serum antibodies bound multiple clusters but showed cluster-specific blockade activity in a surrogate virus neutralization assay. Antibodies secreted by immortalized memory B cells (MBCs) from an infant GII.17 case were highly specific to GII.17 and exhibited blockade activity against this genotype. We isolated an MBC-derived GII.17-specific Immunoglobulin A (IgA) monoclonal antibody called NVA.1 that potently and selectively blocked GII.17 cluster IIIb and recognized an epitope targeted in serum from cluster IIIb-infected children. These data indicate that multiple antigenically distinct GII.17 variants co-circulate in young children, suggesting retention of cluster diversity alongside potential for immune escape given the existence of antibody-defined cluster-specific epitopes elicited during infection.

100 Deals associated with NV-A01

R&D Status

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Indication	Highest Phase	Country/Location	Organization	Date
Advanced Malignant Solid Neoplasm	Phase 1	CN	Nanjing Nuowei Biotechnology Partnership LP	12 Jan 2024

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