Delving into the Latest Updates on QLS1304 with Synapse

Overview

Basic Info

Drug Type

Chemical drugs

Synonyms

Target

KAT6A x KAT6B

Action

inhibitors

Mechanism

KAT6A inhibitors(lysine acetyltransferase 6A inhibitors), KAT6B inhibitors(lysine acetyltransferase 6B inhibitors)

Therapeutic Areas

NeoplasmsSkin and Musculoskeletal Diseases

Active Indication

Advanced cancerAdvanced Malignant Solid NeoplasmER-positive/HER2-negative Breast Cancer

Inactive Indication-

Originator Organization

Qilu Pharmaceutical Co., Ltd.

Active Organization

Shanghai Qilu Pharmaceutical Research Center Co., Ltd.

Qilu Pharmaceutical Co., Ltd.

Inactive Organization-

License Organization-

Drug Highest PhasePhase 1

First Approval Date-

Regulation-

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This study is a multi-center, open label, dose escalation/dose expansion phase I clinical trial aimed at evaluating the safety, tolerability, PK characteristics, and preliminary efficacy characteristics of QLS1304 monotherapy in patients with advanced malignant solid tumors. This study was divided into two stages: dose escalation and dose expansion.

Start Date01 Mar 2025

Sponsor / Collaborator

Qilu Pharmaceutical Co., Ltd.

CTR20250176

/ RecruitingPhase 1

一项评价 OLS1304单药用于治疗晚期实体瘤受试者的安全性、耐受性、药代动力学和初步有效性的1期临床研究

[Translation] A Phase 1 clinical study evaluating the safety, tolerability, pharmacokinetics and preliminary efficacy of OLS1304 monotherapy in subjects with advanced solid tumors

Ia期：主要研究目的：确定QLS1304单药在晚期实体瘤受试者中的安全性、耐受性和2期试验推荐剂量（RP2D）。次要研究目的：评估QLS1304在晚期实体瘤受试者中的药代动力学（PK）特征、初步疗效； Ib期：主要研究目的：评估QLS1304单药在晚期实体瘤受试者中的初步疗效。次要研究目的：评估QLS1304单药在晚期实体瘤受试者中的安全性及PK特征。

[Translation]

Phase Ia: Main study objective: To determine the safety, tolerability and recommended dose (RP2D) of QLS1304 monotherapy in subjects with advanced solid tumors. Secondary study objective: To evaluate the pharmacokinetic (PK) characteristics and preliminary efficacy of QLS1304 in subjects with advanced solid tumors; Phase Ib: Main study objective: To evaluate the preliminary efficacy of QLS1304 monotherapy in subjects with advanced solid tumors. Secondary study objective: To evaluate the safety and PK characteristics of QLS1304 monotherapy in subjects with advanced solid tumors.

Start Date14 Feb 2025

Sponsor / Collaborator

Qilu Pharmaceutical Co., Ltd.

100 Clinical Results associated with QLS1304

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100 Translational Medicine associated with QLS1304

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100 Patents (Medical) associated with QLS1304

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100 Deals associated with QLS1304

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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	-	Qilu Pharmaceutical Co., Ltd.	01 Mar 2025
Advanced Malignant Solid Neoplasm	Phase 1	China	Qilu Pharmaceutical Co., Ltd.	14 Feb 2025
ER-positive/HER2-negative Breast Cancer	Preclinical	China	Shanghai Qilu Pharmaceutical Research Center Co., Ltd.	27 Apr 2025

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


QLS1304 (AACR2025)	Not Applicable	KAT6A amplification \| H3K23Ac \| ER expression ... View more	-	QLS1304	thhjrkwkpm(bvwgyzkffu) = suppressed in KAT6A-high cells sggfyokhdf (hajyqihzqm ) View more	-	27 Apr 2025