Delving into the Latest Updates on Docetaxel albumin bound with Synapse

Overview

Basic Info

Drug Type

Small molecule drug

Synonyms

Albumin-bound docetaxel, Nab-docetaxel, ABI-008

+ [4]

Target

Tubulin

Action

inhibitors

Mechanism

Tubulin inhibitors

Therapeutic Areas

NeoplasmsDigestive System DisordersSkin and Musculoskeletal Diseases+ [4]

Active Indication

Pancreatic CancerPancreatic adenocarcinomaGastroesophageal junction adenocarcinoma+ [27]

Inactive Indication

Castration-Resistant Prostatic CancerMetastatic breast cancerPlatinum-Resistant Ovarian Carcinoma

Originator Organization

Abraxis BioScience, Inc.

Active Organization

CSPC Zhongqi Pharmaceutical Technology Shijiazhuang Co., Ltd.

CSPC Zhongqi Pharmaceutical Technology (Tianjin) Co., Ltd.

Shanghai JMT Biological Technology Co Ltd

+ [2]

Inactive Organization

Celgene Corp.

License Organization-

Drug Highest PhasePhase 3

First Approval Date-

RegulationOrphan Drug (United States)

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A Multicenter, Open-label, Phase II Clinical Study to Evaluate the Safety and Efficacy of Glumetinib Combined With Docetaxel for Injection (Albumin-bound) in Patients With Advanced Gastric Cancer/Gastroesophageal Junction Adenocarcinoma and Other Solid Tumors With MET Overexpression and/or Amplification

The trial consists of Stage 1 (including dose escalation and dose expansion) and Stage 2 (proof-of-concept study). Among them, Stage 2 adopts a randomized, controlled, open-label, and multicenter design.

Start Date30 Apr 2025

Sponsor / Collaborator

CSPC Zhongqi Pharmaceutical Technology (Tianjin) Co., Ltd.

NCT06747338

/ RecruitingPhase 3

A Randomized, Controlled, Open-label, Multicenter, Phase III Clinical Trial to Compare the Efficacy and Safety of KN026 Combined With HB1801 ± Carboplatin Versus Trastuzumab Combined With Pertuzumab and Docetaxel ± Carboplatin in Neoadjuvant Treatment of Early or Locally Advanced HER2-positive Breast Cancer.

This randomized, controlled, open-label, multicenter study will evaluate the safety and efficacy of KN026 in combination with HB1801 ± Carboplatin as neoadjuvant therapy in patients with early or locally advanced HER2-positive breast cancer.

Start Date16 Dec 2024

Sponsor / Collaborator

Shanghai JMT Biological Technology Co Ltd

CTR20244675

/ RecruitingPhase 3

KN026联合HB1801±卡铂对比曲妥珠单抗联合帕妥珠单抗、多西他赛±卡铂新辅助治疗早期或局部晚期HER2阳性乳腺癌的有效性和安全性的随机、对照、开放、多中心、Ⅲ期临床研究

[Translation] A randomized, controlled, open, multicenter, phase III clinical study on the efficacy and safety of KN026 combined with HB1801±carboplatin versus trastuzumab combined with pertuzumab and docetaxel±carboplatin in the neoadjuvant treatment of early or locally advanced HER2-positive breast cancer

主要目的：比较KN026联合HB1801与曲妥珠单抗联合帕妥珠单抗和多西他赛新辅助治疗早期或局部晚期HER2阳性乳腺癌的tpCR（BIRC评估，AJCC第8版）次要目的：评价KN026联合HB1801与曲妥珠单抗联合帕妥珠单抗和多西他赛新辅助治疗早期或局部晚期HER2阳性乳腺癌tpCR（参研中心）、bpCR、ORR、EFS、iDFS 安全性；评价KN026和HB1801的药代动力学特征；评价KN026的免疫原性

[Translation]

Primary purpose: Compare the tpCR of KN026 combined with HB1801 and trastuzumab combined with pertuzumab and docetaxel in neoadjuvant treatment of early or locally advanced HER2-positive breast cancer (BIRC assessment, AJCC 8th edition) Secondary purpose: Evaluate the safety of tpCR (participating centers), bpCR, ORR, EFS, and iDFS of KN026 combined with HB1801 and trastuzumab combined with pertuzumab and docetaxel in neoadjuvant treatment of early or locally advanced HER2-positive breast cancer; evaluate the pharmacokinetic characteristics of KN026 and HB1801; evaluate the immunogenicity of KN026

Start Date16 Dec 2024

Sponsor / Collaborator

Shanghai JMT Biological Technology Co Ltd

[+1]

100 Clinical Results associated with Docetaxel albumin bound

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100 Translational Medicine associated with Docetaxel albumin bound

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100 Patents (Medical) associated with Docetaxel albumin bound

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100 Deals associated with Docetaxel albumin bound

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R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Pancreatic Cancer	Phase 3	-	CSPC Zhongqi Pharmaceutical Technology (Tianjin) Co., Ltd.	12 Aug 2024
Pancreatic adenocarcinoma	Phase 3	China	CSPC Zhongqi Pharmaceutical Technology Shijiazhuang Co., Ltd.	29 Jul 2024
Squamous non-small cell lung cancer	Phase 3	-	Shanghai JMT Biological Technology Co Ltd	01 May 2024
Gastroesophageal junction adenocarcinoma	Phase 3	China	CSPC Zhongqi Pharmaceutical Technology Shijiazhuang Co., Ltd.	15 Mar 2024
stomach adenocarcinoma	Phase 3	China	CSPC Zhongqi Pharmaceutical Technology Shijiazhuang Co., Ltd.	15 Mar 2024
Stomach Cancer	Phase 3	China	CSPC Zhongqi Pharmaceutical Technology (Tianjin) Co., Ltd.	27 Feb 2024
HER2 Positive Breast Cancer	Phase 3	-	Shanghai JMT Biological Technology Co Ltd	01 Jul 2023
Advanced gastric carcinoma	Phase 2	China	CSPC Zhongqi Pharmaceutical Technology Shijiazhuang Co., Ltd.	28 Apr 2025
Advanced Malignant Solid Neoplasm	Phase 2	China	CSPC Zhongqi Pharmaceutical Technology Shijiazhuang Co., Ltd.	28 Apr 2025
c-Met positive non-small cell lung cancer	Phase 2	-	CSPC Zhongqi Pharmaceutical Technology (Tianjin) Co., Ltd.	01 Jul 2024

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT05705635 (ASCO_GI2025) Manual	Phase 2	stomach adenocarcinoma \| Gastroesophageal junction adenocarcinoma Second line	128	HB1801	omaoyfsrcf(xjfwfkqzqb) = zyvchrfhli gvjlqyxgiz (tikzawoigo, 2.8 - 4.2) View more	Positive	23 Jan 2025
				Docetaxel	omaoyfsrcf(xjfwfkqzqb) = luqcphpobz gvjlqyxgiz (tikzawoigo, 1.8 - 3.0) View more
NCT05705635 (ASCO2024) Manual	Phase 2	Advanced Gastric Adenocarcinoma \| Advanced Gastroesophageal Junction Adenocarcinoma	125	HB1801 (albumin-bound docetaxel)	lxtbbugijf(zsmgditwpy) = tldepheubb whhlsliwwb (cnfpgcrffh, 12.88 - 39.54) View more	Positive	24 May 2024
				docetaxel (Taxotere)	lxtbbugijf(zsmgditwpy) = xesvcozlro whhlsliwwb (cnfpgcrffh, 6.20 - 28.31) View more
NCT04931823 (ASCO2024) Manual	Phase 1	Advanced Malignant Solid Neoplasm	34	CPO-100 (albumin bound docetaxel)	zlwblaskap(ivreqkfjfm) = yezumbzvcc wmascgqwsu (xvwogkfgtw ) View more	Positive	24 May 2024