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

+ [4]

Target

Tubulin

Mechanism

Tubulin inhibitors

Therapeutic Areas

NeoplasmsDigestive System DisordersSkin and Musculoskeletal Diseases+ [4]

Active Indication

Pancreatic CancerGastroesophageal junction adenocarcinomastomach adenocarcinoma+ [19]

Inactive Indication

Castration-Resistant Prostatic CancerMetastatic breast cancer

Originator Organization

Abraxis BioScience, Inc.

Active Organization

CSPC Zhongqi Pharmaceutical Technology Shijiazhuang Co., Ltd.

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

Conjupro Biotherapeutics, Inc.

+ [2]

Inactive Organization

Celgene Corp.

Drug Highest PhasePhase 3

First Approval Date-

RegulationOrphan Drug (US)

Login to view timeline

This study is a randomized, double-blind, multicenter, phase Ⅲ clinical study to compare the clinical efficacy and safety of Docetaxel for Injection (Albumin Bound) in combination with best supportive care versus placebo in combination with best supportive care in participants with pancreatic cancer who have received gemcitabine-containing and fluorouracil-containing regimens.

Start Date12 Aug 2024

Sponsor / Collaborator

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

CTR20242306 / RecruitingPhase 3

注射用多西他赛（白蛋白结合型）联合最佳支持治疗对比安慰剂联合最佳支持治疗在晚期胰腺癌中的随机、双盲、多中心III期临床研究

[Translation] A randomized, double-blind, multicenter phase III clinical study of docetaxel (albumin-bound) for injection combined with best supportive care versus placebo combined with best supportive care in advanced pancreatic cancer

主要目的：评价注射用多西他赛（白蛋白结合型）联合最佳支持治疗对比安慰剂联合最佳支持治疗在晚期胰腺癌中的疗效（OS）。次要目的：1. 评价注射用多西他赛（白蛋白结合型）联合最佳支持治疗对比安慰剂联合最佳支持治疗在晚期胰腺癌中的疗效（PFS、ORR、DCR和DOR）；2. 评价注射用多西他赛（白蛋白结合型）在晚期胰腺癌中的安全性；3. 评价注射用多西他赛（白蛋白结合型）的PK特征。

[Translation]

Primary objective: To evaluate the efficacy (OS) of docetaxel (albumin-bound) for injection combined with best supportive care versus placebo combined with best supportive care in advanced pancreatic cancer. Secondary objectives: 1. To evaluate the efficacy (PFS, ORR, DCR and DOR) of docetaxel (albumin-bound) for injection combined with best supportive care versus placebo combined with best supportive care in advanced pancreatic cancer; 2. To evaluate the safety of docetaxel (albumin-bound) for injection in advanced pancreatic cancer; 3. To evaluate the PK characteristics of docetaxel (albumin-bound) for injection.

Start Date29 Jul 2024

Sponsor / Collaborator

CSPC Zhongqi Pharmaceutical Technology Shijiazhuang Co., Ltd.

NCT06525350 / Not yet recruitingPhase 2

A Randomized, Controlled, Open-label Phase Ⅱ Study to Evaluate the Safety, Tolerability, and Efficacy of the Combination of Glumetinib Tablets and Docetaxel for Injection（Albumin Bound）Verse Docetaxel in the Treatment of Locally Advanced/Recurrent or Distant Metastasized Non-small Cell Lung Cancer Patients With MET Overexpression

This study consists of Stage 1 (including dose escalation and dose expansion) and Stage 2 (randomized controlled study). The main purpose of Stage 1 is to preliminarily evaluate the safety and tolerability of the combination of glumetinib Tablets and Docetaxel for Injection（Albumin Bound）(HB1801) in the treatment of MET-overexpressed non-small cell lung cancer (NSCLC); The main purpose of Stage 2 is to evaluate the efficacy of the combination of glumetinib tablets and HB1801 compared to glumetinib tablets monotherapy or docetaxel in the treatment of MET-expressed NSCLC.

Start Date01 Jul 2024

Sponsor / Collaborator

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

100 Clinical Results associated with Docetaxel albumin bound

Login to view more data

100 Translational Medicine associated with Docetaxel albumin bound

Login to view more data

100 Patents (Medical) associated with Docetaxel albumin bound

Login to view more data

18

Literatures (Medical) associated with Docetaxel albumin bound

01 Dec 2022·Journal of Nanobiotechnology

Construction of gastric cancer patient-derived organoids and their utilization in a comparative study of clinically used paclitaxel nanoformulations

Article

Author: Guo, Peilin ; Chai, Ningli ; Wang, Shuang ; Ye, Peng ; Li, Feng ; Zou, Jiale ; Yue, Hua ; Wei, Wei ; Ma, Guanghui ; Linghu, Enqiang ; Wei, Bo

AbstractBackgroundGastric cancer (GC) is a highly heterogeneous disease with many different histological and molecular subtypes. Due to their reduced systemic adverse effects, nanoformulation agents have attracted increasing attention for use in the treatment of GC patients in the clinic. To improve therapeutic outcomes, it is vitally necessary to provide individual medication references and guidance for use of these nanoformulations, and patient-derived organoids (PDOs) are promising models through which to achieve this goal.ResultsUsing an improved enzymatic digestion process, we succeeded in constructing GC PDOs from surgically resected tumor tissues and endoscopic biopsies from GC patients; these PDOs closely recapitulated the histopathological and genomic features of the corresponding primary tumors. Next, we chose two representative paclitaxel (PTX) nanoformulations for comparative study and found that liposomal PTX outperformed albumin-bound PTX in killing GC PDOs at both the transcriptome and cellular levels. Our results further showed that the different distributions of liposomal PTX and albumin-bound PTX in PDOs played an essential role in the distinct mechanisms through which they kill PDOs. Finally, we constructed patient-derived xenografts model in which we verified the above distinct therapeutic outcomes via an intratumoral administration route.ConclusionsThis study demonstrates that GC PDOs are reliable tools for predicting nanoformulation efficacy.Graphical Abstract

01 Jun 2021·Annals of Palliative MedicineQ4 · MEDICINE

Complete and enduring response in an elderly patient with repeated recurrent gingival squamous cell carcinoma treated by combined toripalimab and single agent chemotherapy: a case report

Q4 · MEDICINE

Article

Author: Wu, Qiuji ; Hua, Xinying ; Zhang, Shuyuan ; Zhong, Yahua ; Yu, Haijun

Combined immune checkpoint inhibitor with platinum-based doublet chemotherapy brought about significant improvement in overall survival as the first line treatment in metastatic and recurrent head and neck cancer patients. However, in elderly patients with relatively poor performance status, these regimens might not be well tolerated. Therefore, we evaluated the safety and effect of combined immunotherapy and single agent chemotherapy in an elderly patient with recurrent head and neck squamous cell carcinoma. A 78-year-old male patients with a repeatedly recurrent gingival squamous cell carcinoma was admitted in our institute. Previously this patient underwent two consecutive surgical resections of recurrent tumors before the second rapid recurrence that resulted in extended tumor mass and lymph node metastasis. As the patient was in a relatively poor performance status (performance status =2), immunotherapy with PD-1 antibody (Toripalimab) combined with single agent chemotherapy (two cycle with albumin-bound paclitaxel and then six cycles with gemcitabine) was administrated, which led to clinical complete response after 8 cycles of treatment. The patient continued 4 cycles of maintenance immunotherapy with Toripalimab until the outbreak of the coronavirus disease 2019. The treatment was well tolerated and the patient remained free from disease until the last follow up by June 2020, 16 months after the initiation of treatment. The success in this case indicated that the combination of anti-PD-1 antibody and single chemotherapy agent may also be effective as well as safe in elderly patients with recurrent head and neck squamous cell carcinoma.

01 Jun 2021·Nanomedicine: Nanotechnology, Biology and MedicineQ2 · MEDICINE

Albumin-stabilized layered double hydroxide nanoparticles synergized combination chemotherapy for colorectal cancer treatment

Q2 · MEDICINE

Article

Author: Xu, Zhi Ping ; Wang, Peng-Yuan ; Han, Felicity Y ; Qian, Yujin ; Sun, Luyao ; Li, Li ; Zhang, Run

Combination chemotherapy with two or more complimentary drugs has been widely used for clinical cancer treatment. However, the efficacy and side effects of combination chemotherapy still remain a challenge. Here, we constructed an albumin-stabilized layered double hydroxide nanoparticle (BLDH) system to simultaneously load and deliver two widely used anti-tumor drugs, i.e. 5-fluorouracil (5FU) and albumin-bound PTX (Abraxane, ABX) for colorectal cancer treatment. The cellular uptake test has revealed that 5FU-ABX encapsulated BLDH (BLDH/5FU-ABX) nanoparticles were efficiently internalized by the colorectal cancer cell (HCT-116), synergistically inducing apoptosis of colon cancer cells. The in vivo test has demonstrated that BLDH/5FU-ABX nanomedicine significantly inhibited the tumor growth after three intravenous injections, without any detectable side effects. The enhanced therapeutic effectiveness is attributed to efficient accumulation of BLDH/5FU-ABX at tumor sites and acid-sensitive release of co-loaded drugs. Thus, combination chemotherapy based on BLDH/5FU-ABX nanomedicine would be a new strategy for colorectal cancer treatment.

100 Deals associated with Docetaxel albumin bound

Login to view more data

R&D Status

10 top R&D records.

Login

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Pancreatic Cancer	Phase 3	CN	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	CN	CSPC Zhongqi Pharmaceutical Technology Shijiazhuang Co., Ltd.	15 Mar 2024
stomach adenocarcinoma	Phase 3	CN	CSPC Zhongqi Pharmaceutical Technology Shijiazhuang Co., Ltd.	15 Mar 2024
HER2 Positive Breast Cancer	Phase 3	-	Shanghai JMT Biological Technology Co Ltd	01 Jul 2023
Metastatic breast cancer	Phase 3	US	Celgene Corp.	01 Nov 2007
Recurrent ovarian cancer	Phase 2	CN	CSPC Zhongqi Pharmaceutical Technology Shijiazhuang Co., Ltd.	18 Aug 2022
Recurrent Cutaneous Squamous Cell Carcinoma of the Head and Neck	Phase 2	CN	CSPC Zhongqi Pharmaceutical Technology Shijiazhuang Co., Ltd.	04 Mar 2022
Squamous cell carcinoma of head and neck metastatic	Phase 2	CN	CSPC Zhongqi Pharmaceutical Technology Shijiazhuang Co., Ltd.	04 Mar 2022
Castration-Resistant Prostatic Cancer	Phase 2	US	Celgene Corp.	01 Apr 2007

Login to view more data

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04931823 (ASCO2024) Manual	Phase 1	Advanced Malignant Solid Neoplasm	34	CPO-100 (albumin bound docetaxel)	(gxtbzskywe) = pkjvlhzzuj kqbkvnmcxa (cnfbgamfmb ) View more	Positive	24 May 2024
ASCO2021	Not Applicable	Breast Cancer Neoadjuvant	263	Paclitaxel-based NAC	(ytwwrqzypk) = ufffxltvzg fwhybnjxwq (ygjwmqzljg )	-	28 May 2021
ASCO2021	Not Applicable	Breast Cancer Neoadjuvant	263	Docetaxel-based NAC	(ytwwrqzypk) = euszfdbppi fwhybnjxwq (ygjwmqzljg )	-	28 May 2021