Delving into the Latest Updates on AL58805 with Synapse

Overview

Basic Info

Drug Type

Small molecule drug

Synonyms

AL 58805, AL-58805

Target

PI3Ks x mTOR

Action

inhibitors

Mechanism

PI3K family inhibitors(Phosphatidylinositol 3-kinase family inhibitors), mTOR inhibitors(Serine/threonine-protein kinase mTOR inhibitors)

Therapeutic Areas

NeoplasmsImmune System DiseasesDigestive System Disorders+ [6]

Active Indication

NeoplasmsChronic Lymphocytic LeukemiaSmall Lymphocytic Lymphoma+ [8]

Inactive Indication-

Originator Organization

Advenchen Laboratories Nanjing Ltd.

Active Organization

Zhejiang University

Advenchen Laboratories Nanjing Ltd.

Advenchen Laboratories LLC

Inactive Organization-

Drug Highest PhasePhase 1

First Approval Date-

Regulation-

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研究晚期实体瘤患者单次和多次给予AL58805后的耐受性和安全性，观测给药后人体的DLT和MTD，毒性的可逆程度、毒性与剂量关系。研究分析AL58805片在晚期实体瘤患者体内的药代动力学特征。根据I期耐受性试验和药代动力学结果为II期临床试验推荐合适的给药剂量和方案；初步评估AL58805在晚期实体瘤患者中的疗效。

[Translation]

Study the tolerance and safety of AL58805 after single and multiple administrations in patients with advanced solid tumors, observe the DLT and MTD of the human body after administration, the reversibility of toxicity, and the relationship between toxicity and dose. Study and analyze the pharmacokinetic characteristics of AL58805 tablets in patients with advanced solid tumors. Recommend appropriate dosage and regimen for Phase II clinical trials based on Phase I tolerance and pharmacokinetic results; preliminarily evaluate the efficacy of AL58805 in patients with advanced solid tumors.

Start Date-

Sponsor / Collaborator

Hangzhou Edcheng Pharmaceutical Technology Co., Ltd.

[+2]

CTR20210794

/ Not yet recruitingPhase 1

AL58805 治疗晚期肿瘤患者的剂量递增耐受性和药代动力学Ⅰ期临床研究

[Translation] Phase I clinical study on dose escalation tolerance and pharmacokinetics of AL58805 in patients with advanced tumors

主要目的：（1）研究晚期实体瘤患者单次和多次给予 AL58805 后的耐受性和安全性，观测给药后人体的剂量限制性毒性（DLT）和最大耐受剂量（MTD），毒性的可逆程度、毒性与剂量关系。（2）研究分析 AL58805 片在晚期实体瘤患者体内的药代动力学特征。次要目的： 1) 根据 I 期耐受性试验和药代动力学结果为 II 期临床试验推荐合适的给药剂量和方案； 2) 初步评估 AL58805 在晚期实体瘤患者中的疗效。

[Translation]

Main objectives: (1) To study the tolerance and safety of AL58805 after single and multiple administrations in patients with advanced solid tumors, to observe the dose-limiting toxicity (DLT) and maximum tolerated dose (MTD) in humans after administration, the reversibility of toxicity, and the relationship between toxicity and dose. (2) To study and analyze the pharmacokinetic characteristics of AL58805 tablets in patients with advanced solid tumors. Secondary objectives: 1) To recommend appropriate dosage and regimen for Phase II clinical trials based on the results of Phase I tolerance tests and pharmacokinetic studies; 2) To preliminarily evaluate the efficacy of AL58805 in patients with advanced solid tumors.

Start Date-

Sponsor / Collaborator

Hangzhou Edcheng Pharmaceutical Technology Co., Ltd.

[+2]

CTR20212290

/ Not yet recruitingPhase 1

AL58805 片在血液肿瘤受试者中的耐受性和药代动力学I期临床研究

[Translation] Phase I clinical study on the tolerability and pharmacokinetics of AL58805 tablets in subjects with hematological malignancies

主要目的：1、研究血液肿瘤患者单次和多次给予 AL58805 后的耐受性和安全性，观测给药后人体的剂量限制性毒性（DLT）和最大耐受剂量（MTD），毒性的可逆程度、毒性与剂量关系。2、初步研究分析 AL58805 片在血液肿瘤患者体内的药代动力学特征；次要目的：1、根据 I 期耐受性试验和药代动力学结果为 II 期临床试验推荐合适的给药剂量和方案；2、初步评估 AL58805 在血液肿瘤患者中的疗效

[Translation]

Main purpose: 1. To study the tolerance and safety of AL58805 after single and multiple administrations in patients with hematological tumors, to observe the dose-limiting toxicity (DLT) and maximum tolerated dose (MTD) in humans after administration, the reversibility of toxicity, and the relationship between toxicity and dose. 2. To preliminarily study and analyze the pharmacokinetic characteristics of AL58805 tablets in patients with hematological tumors; Secondary purpose: 1. To recommend appropriate dosage and regimen for Phase II clinical trials based on Phase I tolerance test and pharmacokinetic results; 2. To preliminarily evaluate the efficacy of AL58805 in patients with hematological tumors

Start Date-

Sponsor / Collaborator

Hangzhou Edcheng Pharmaceutical Technology Co., Ltd.

[+2]

100 Clinical Results associated with AL58805

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100 Translational Medicine associated with AL58805

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100 Patents (Medical) associated with AL58805

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100 Deals associated with AL58805

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R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Neoplasms	Phase 1	China	Advenchen Laboratories LLC	30 Jan 2022
Chronic Lymphocytic Leukemia	Phase 1	China	Zhejiang University	09 Sep 2021
Chronic Lymphocytic Leukemia	Phase 1	China	Advenchen Laboratories Nanjing Ltd.	09 Sep 2021
Small Lymphocytic Lymphoma	Phase 1	China	Zhejiang University	09 Sep 2021
Small Lymphocytic Lymphoma	Phase 1	China	Advenchen Laboratories Nanjing Ltd.	09 Sep 2021
Advanced cancer	Phase 1	China	Zhejiang University	14 Jan 2019
Advanced cancer	Phase 1	China	Advenchen Laboratories Nanjing Ltd.	14 Jan 2019
Bile Duct Neoplasms	Phase 1	China	Advenchen Laboratories Nanjing Ltd.	14 Jan 2019
Bile Duct Neoplasms	Phase 1	China	Zhejiang University	14 Jan 2019
Bladder Cancer	Phase 1	China	Advenchen Laboratories Nanjing Ltd.	14 Jan 2019