Delving into the Latest Updates on JR8603 with Synapse

Overview

Basic Info

Drug Type

Chemical drugs

Synonyms

Target-

Mechanism-

Therapeutic Areas

Neoplasms

Active Indication

Advanced Malignant Solid Neoplasm

Inactive Indication-

Originator Organization

JiaRay Therapeutics, Inc.

Active Organization

Jiangsu Jiarui Biotechnology Co., Ltd.JiaRay Pharmaceuticals, Inc.

Pharmaceutics International, Inc.

Inactive Organization-

Drug Highest PhasePhase 1

First Approval Date-

Regulation-

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一、剂量递增（第1部分）主要目的：评价JR8603 的安全性和耐受性；确定最大耐受剂量(MTD)和/II 期推荐剂量（ RP2D ）。次要目的：确定JR8603 在晚期实体瘤中的有效性；评估JR8603 的药代动力学（PK）特征。探索性目的：通过血清和肿瘤组织中生物标志物的表达以及血清Legumain 水平评估ORR。二、剂量扩展（第2部分）主要目的：确定MTD/RP2D 下JR8603 的安全性和耐受性；评估各队列有效性的初步证据。次要目的：进一步评估JR8603 的PK 特征；确定JR8603 在各队列的有效性。探索性目的：通过血清和肿瘤组织中生物标志物的表达以及血清Legumain 水平评估ORR。

[Translation]

I. Dose escalation (Part 1) Primary objectives: Evaluate the safety and tolerability of JR8603; determine the maximum tolerated dose (MTD) and/phase II recommended dose (RP2D). Secondary objectives: Determine the efficacy of JR8603 in advanced solid tumors; evaluate the pharmacokinetic (PK) characteristics of JR8603. Exploratory objectives: Evaluate ORR by the expression of biomarkers in serum and tumor tissues and serum Legumain levels. II. Dose expansion (Part 2) Primary objectives: Determine the safety and tolerability of JR8603 under MTD/RP2D; evaluate the preliminary evidence of efficacy in each cohort. Secondary objectives: Further evaluate the PK characteristics of JR8603; determine the efficacy of JR8603 in each cohort. Exploratory objectives: Evaluate ORR by the expression of biomarkers in serum and tumor tissues and serum Legumain levels.

Start Date-

Sponsor / Collaborator

Jiangsu Jiarui Biotechnology Co., Ltd.

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100 Clinical Results associated with JR8603

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100 Translational Medicine associated with JR8603

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100 Patents (Medical) associated with JR8603

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100 Deals associated with JR8603

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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	Jiangsu Jiarui Biotechnology Co., Ltd.	30 Sep 2024
Advanced Malignant Solid Neoplasm	Phase 1	CN	JiaRay Pharmaceuticals, Inc.	30 Sep 2024
Advanced Malignant Solid Neoplasm	Phase 1	CN	Pharmaceutics International, Inc.	30 Sep 2024