Delving into the Latest Updates on VB15010 with Synapse

Overview

Basic Info

Drug Type

Chemical drugs

Synonyms

VB15010

Target

PARP1

Mechanism

PARP1 inhibitors(Poly (ADP-Ribose) polymerase 1 inhibitors)

Therapeutic Areas

Neoplasms

Active Indication

Advanced Malignant Solid Neoplasm

Inactive Indication-

Originator Organization

Shenzhen Yangli Pharmaceutical Technology Co. Ltd.

Active Organization

Shenzhen Yangli Pharmaceutical Technology Co. Ltd.

Inactive Organization-

Drug Highest PhasePhase 1/2

First Approval Date-

Regulation-

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主要目的：评估晚期实体瘤受试者接受VB15010给药的安全性、耐受性；确定VB15010单药治疗的最大耐受剂量（MTD）、Ⅱ期推荐剂量（RP2D）；确定VB15010单药治疗的给药方案。次要目的：评价VB15010在晚期实体瘤受试者体内药代动力学（PK）特征；评价VB15010治疗晚期实体瘤受试者的初步疗效。探索性目的（I期）：探索PARylation和/或HRR基因突变（包括但不限于BRCA1/2、PALB2、RAD51C/D等）与疗效指标的相关性。

[Translation]

Primary objectives: To evaluate the safety and tolerability of VB15010 in subjects with advanced solid tumors; To determine the maximum tolerated dose (MTD) and phase II recommended dose (RP2D) of VB15010 monotherapy; To determine the dosing regimen of VB15010 monotherapy. Secondary objectives: To evaluate the pharmacokinetic (PK) characteristics of VB15010 in subjects with advanced solid tumors; To evaluate the preliminary efficacy of VB15010 in the treatment of subjects with advanced solid tumors. Exploratory objectives (Phase I): To explore the correlation between PARylation and/or HRR gene mutations (including but not limited to BRCA1/2, PALB2, RAD51C/D, etc.) and efficacy indicators.

Start Date-

Sponsor / Collaborator