Delving into the Latest Updates on XZP-7797-H1 with Synapse

Overview

Basic Info

Drug Type

Chemical drugs

Synonyms

XZP-7797-H1

Target

PARP1

Action

inhibitors

Mechanism

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

Therapeutic Areas

Neoplasms

Active Indication

Advanced Malignant Solid Neoplasm

Inactive Indication-

Originator Organization

Xuanzhu Biopharmaceutical Co., Ltd.

Active Organization

Xuanzhu Biopharmaceutical Co., Ltd.

Inactive Organization-

License Organization-

Drug Highest PhasePhase 1

First Approval Date-

Regulation-

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主要目的: 1. 评价XZP-7797-H1片单药治疗晚期实体瘤受试者的安全性和耐受性，确定MTD（如有）及 RP2D。次要目的: 1. 评价XZP-7797-H1片单药治疗晚期实体瘤受试者的初步疗效； 2. 评价XZP-7797-H1片单药在晚期实体瘤受试者体内的药代动力学特征。探索性目的: 1. 探索PARylation、BRCA1/2突变、HRD状态及HRR等肿瘤相关基因突变与XZP-7797-H1片抗肿瘤疗效的相关性； 2. 初步鉴定XZP-7797-H1在受试者血浆中的代谢产物。

[Translation]

Primary Objectives: 1. To evaluate the safety and tolerability of XZP-7797-H1 tablets as a single agent in subjects with advanced solid tumors and determine the MTD (if available) and RP2D. Secondary Objectives: 1. To evaluate the preliminary efficacy of XZP-7797-H1 tablets as a single agent in subjects with advanced solid tumors; 2. To evaluate the pharmacokinetic characteristics of XZP-7797-H1 tablets as a single agent in subjects with advanced solid tumors. Exploratory Objectives: 1. To investigate the correlation between PARylation, BRCA1/2 mutations, HRD status, and HRR mutations in tumor-related genes and the anti-tumor efficacy of XZP-7797-H1 tablets; 2. To preliminarily identify the metabolites of XZP-7797-H1 in subject plasma.

Start Date-

Sponsor / Collaborator