Delving into the Latest Updates on QLC1401 with Synapse

Overview

Basic Info

Drug Type

Chemical drugs

Synonyms

QLC1401

Target-

Action-

Mechanism-

Therapeutic Areas

NeoplasmsSkin and Musculoskeletal Diseases

Active Indication

Advanced breast cancerER-positive/HER2-negative Breast CancerHER2-negative breast cancer

Inactive Indication-

Originator Organization

Qilu Pharmaceutical Co., Ltd.

Active Organization

Qilu Pharmaceutical Co., Ltd.

Shenzhen Yangli Pharmaceutical Technology Co. Ltd.

Inactive Organization-

License Organization-

Drug Highest PhasePhase 1/2

First Approval Date-

Regulation-

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Evaluation of Safety, Tolerability, Efficacy, and Pharmacokinetic Characteristics of QLC1401 Tablets Combined With CDK4/6 Inhibitors or mTOR Inhibitors in Patients With Estrogen Receptor-Positive (ER+), Human Epidermal Growth Factor Receptor 2-Negative (HER2-) Locally Advanced or Metastatic Breast Cancer: A Phase Ib/II Clinical Study

This study is an open-label, multicenter, Phase Ib/II clinical trial designed to evaluate the safety, tolerability, efficacy, and pharmacokinetic characteristics of QLC1401 tablets in combination with CDK4/6 inhibitors or mTOR inhibitors in patients with ER+/HER2- locally advanced or metastatic breast cancer. The study consists of two stages: a Phase Ib dose-escalation stage and a Phase II dose-expansion stage.

Start Date01 Sep 2025

Sponsor / Collaborator

Qilu Pharmaceutical Co., Ltd.

CTR20261845

/ Not yet recruitingPhase 1

QLC1401片的食物影响研究

[Translation] Food Influence Study of QLC1401 Tablets

主要目的：评价健康参与者在空腹、低脂餐后和高脂餐后单次口服 QLC1401片 150 mg的药代动力学特征（ PK）以及食物对 QLC1401药代动力学的影响。次要目的：评价健康参与者在空腹、低脂餐后和高脂餐后单次口服 QLC1401片 150 mg的安全性。

[Translation]

Primary objective: To evaluate the pharmacokinetic characteristics (PK) of a single oral dose of QLC1401 tablets 150 mg in healthy participants after fasting, low-fat meals, and high-fat meals, and to assess the effect of food on the pharmacokinetics of QLC1401. Secondary objective: To evaluate the safety of a single oral dose of QLC1401 tablets 150 mg in healthy participants after fasting, low-fat meals, and high-fat meals.

Start Date-

Sponsor / Collaborator

Shenzhen Yangli Pharmaceutical Technology Co. Ltd.

100 Clinical Results associated with QLC1401

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100 Translational Medicine associated with QLC1401

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100 Patents (Medical) associated with QLC1401

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100 Deals associated with QLC1401

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R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Advanced breast cancer	Phase 2	-	Qilu Pharmaceutical Co., Ltd.	01 Sep 2025
ER-positive/HER2-negative Breast Cancer	Phase 2	-	Qilu Pharmaceutical Co., Ltd.	01 Sep 2025
HER2-negative breast cancer	Phase 1	China	Shenzhen Yangli Pharmaceutical Technology Co. Ltd.	13 May 2026