CD19 modulators(B-lymphocyte antigen CD19 modulators), CD20 modulators(B-lymphocyte antigen CD20 modulators), CD3 modulators(T cell surface glycoprotein CD3 modulators)

Therapeutic Areas

Neoplasms

Active Indication

Advanced Malignant Solid Neoplasm

Inactive Indication-

Originator Organization

Chengdu Enmu Biotechnology Co., Ltd

Active Organization

BioRay Biopharmaceutical Co., Ltd.

Chengdu Enmu Biotechnology Co., Ltd

Inactive Organization-

Drug Highest PhasePhase 1

First Approval Date-

Regulation-

Clinical Trials associated with BR-115

NCT06388902 / Not yet recruitingPhase 1

A Phase I Clinical Study of the Safety, Tolerability and Efficacy of BR115 for Injection in Patients With Advanced Solid Malignancies

This is a Phase I, multicenter, open-label, single-arm and first-in-human clinical study of BR115 for injection. The study objectives are to evaluate the safety, tolerability, pharmacokinetic profile, anti-tumor activity and immunogenicity of BR115 for injection in patients with advanced solid malignancies.
Patients will receive two doses at the first week of treatment, followed by once per week until intolerable toxicity, disease progression, pregnancy, withdrawal of informed consent, death, study discontinuation, or withdrawal from the study.

Start Date01 Apr 2024

Sponsor / Collaborator

BioRay Biopharmaceutical Co., Ltd.

CTR20241410 / Not yet recruitingPhase 1

BR115注射液在晚期恶性实体肿瘤患者中的安全性、耐受性和有效性的I期临床研究

[Translation] A Phase I clinical study on the safety, tolerability and efficacy of BR115 injection in patients with advanced malignant solid tumors

主要目的：评价BR115注射液在晚期恶性实体肿瘤患者中的安全性、耐受性，确定BR115注射液的最大耐受剂量（MTD）和/或Ⅱ期临床推荐剂量（RP2D）。次要目的： (1) 评价BR115注射液在晚期恶性肿瘤患者中的初步有效性。 (2) 评价BR115注射液在晚期恶性肿瘤患者中的药代动力学特征。 (3) 评价BR115注射液的免疫原性。 (4) 初步评价患者HER2表达水平与临床疗效的相关性。 (5) 如数据允许，初步评价BR115注射液的PK、疗效、安全之间的相关性。 (6) 该研究数据将纳入PopPK分析数据集，基于Pop-PK分析方法，描述BR115注射液在晚期恶性肿瘤患者中的群体PK特征。

[Translation]

Primary objectives: To evaluate the safety and tolerability of BR115 injection in patients with advanced malignant solid tumors, and to determine the maximum tolerated dose (MTD) and/or phase II clinical recommended dose (RP2D) of BR115 injection. Secondary objectives: (1) To evaluate the preliminary efficacy of BR115 injection in patients with advanced malignant tumors. (2) To evaluate the pharmacokinetic characteristics of BR115 injection in patients with advanced malignant tumors. (3) To evaluate the immunogenicity of BR115 injection. (4) To preliminarily evaluate the correlation between the patient's HER2 expression level and clinical efficacy. (5) If data permit, preliminarily evaluate the correlation between the PK, efficacy and safety of BR115 injection. (6) The data from this study will be included in the PopPK analysis data set, and based on the Pop-PK analysis method, the population PK characteristics of BR115 injection in patients with advanced malignant tumors will be described.

Start Date-

Sponsor / Collaborator

Hisun Bio Pharmaceutical Co., Ltd.

[+2]

100 Clinical Results associated with BR-115

100 Translational Medicine associated with BR-115

100 Patents (Medical) associated with BR-115

100 Deals associated with BR-115

R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Advanced Malignant Solid Neoplasm	Phase 1	CN	BioRay Biopharmaceutical Co., Ltd.	01 Apr 2024

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