Delving into the Latest Updates on DAT-2645 with Synapse

Overview

Basic Info

Drug Type

Small molecule drug

Synonyms

Target

PARG

Mechanism

PARG inhibitors(Poly(ADP-ribose) glycohydrolase inhibitors)

Therapeutic Areas

NeoplasmsDigestive System DisordersEndocrinology and Metabolic Disease+ [2]

Active Indication

Advanced cancerBreast CancerColorectal Cancer+ [7]

Inactive Indication-

Originator Organization

Beijing Danqing Pharmaceutical Technology Co., Ltd.

Active Organization

Beijing Danqing Pharmaceutical Technology Co., Ltd.

Inactive Organization-

Drug Highest PhasePhase 1

First Approval Date-

Regulation-

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[Translation] A dose-escalation, dose-expansion, open-label, Phase I study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary efficacy of DAT-2645 in patients with advanced/metastatic solid tumors harboring BRCA1/2 loss-of-function mutations and/or other defects in the DNA damage repair (DDR) pathway

本研究主要目的为评估PARG抑制剂DAT-2645在携带BRCA1/2功能缺失突变和/或DDR通路中其他缺陷的晚期或转移性实体瘤中的安全性、耐受性、PK、PD指标及初步临床疗效，确定MTD和RP2D，为后续开展临床试验提供I期临床试验数据。

[Translation]

The main purpose of this study is to evaluate the safety, tolerability, PK, PD indicators and preliminary clinical efficacy of the PARG inhibitor DAT-2645 in advanced or metastatic solid tumors carrying BRCA1/2 loss-of-function mutations and/or other defects in the DDR pathway, determine the MTD and RP2D, and provide Phase I clinical trial data for subsequent clinical trials.

Start Date-

Sponsor / Collaborator

Beijing Danqing Pharmaceutical Technology Co., Ltd.

NCT06614751 / Not yet recruitingPhase 1

A Phase I, Open-label, Dose Escalation and Dose Expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Preliminary Efficacy of DAT-2645 in Patients with Advanced/Metastatic Solid Tumors Harboring BRCA1/2 Loss of Function Alterations And/or Other Defects in the DNA Damage Repair Pathway

The primary objective of the study is to evaluate the safety, tolerability, PK, PD, and prilimary efficacy of a PARG inhibitor DAT-2645 in patients with advanced/metastatic solid tumors harboring BRCA1/2 loss of function alterations and/or other defects in the DNA damage repair (DDR) pathway.

Start Date01 Nov 2024

Sponsor / Collaborator

Beijing Danqing Pharmaceutical Technology Co., Ltd.

100 Clinical Results associated with DAT-2645

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100 Translational Medicine associated with DAT-2645

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100 Patents (Medical) associated with DAT-2645

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100 Deals associated with DAT-2645

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R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Advanced cancer	Phase 1	CN	Beijing Danqing Pharmaceutical Technology Co., Ltd.	01 Nov 2024
Breast Cancer	Phase 1	CN	Beijing Danqing Pharmaceutical Technology Co., Ltd.	01 Nov 2024
Colorectal Cancer	Phase 1	CN	Beijing Danqing Pharmaceutical Technology Co., Ltd.	01 Nov 2024
Endometrial Carcinoma	Phase 1	CN	Beijing Danqing Pharmaceutical Technology Co., Ltd.	01 Nov 2024
Metastatic Solid Tumor	Phase 1	CN	Beijing Danqing Pharmaceutical Technology Co., Ltd.	01 Nov 2024
Pancreatic Cancer	Phase 1	CN	Beijing Danqing Pharmaceutical Technology Co., Ltd.	01 Nov 2024
Prostatic Cancer	Phase 1	CN	Beijing Danqing Pharmaceutical Technology Co., Ltd.	01 Nov 2024
Stomach Cancer	Phase 1	CN	Beijing Danqing Pharmaceutical Technology Co., Ltd.	01 Nov 2024
BRCA-Mutated Malignant Neoplasm	IND Approval	US	Beijing Danqing Pharmaceutical Technology Co., Ltd.	24 Jun 2024
HRD positive cancer	IND Approval	US	Beijing Danqing Pharmaceutical Technology Co., Ltd.	24 Jun 2024