MedPath

Disitamab vedotin

Generic Name
Disitamab vedotin
Drug Type
Biotech
CAS Number
2136633-23-1
Unique Ingredient Identifier
RB3U3A1S27
Background

Disitamab vedotin is an antibody-drug conjugate drug targeting human epidermal growth factor receptor 2 (HER2). It is currently being investigated for cancers.

Indication

用于至少接受过2个系统化疗的HER2过表达局部晚期或转移性胃癌(包括胃食管结合部腺癌)的患者,HER2过表达定义为HER2免疫组织化学检查结果为2+或3+。

A Study of RC48-ADC in Local Advanced or Metastatic Gastric Cancer With the HER2-Overexpression

Phase 3
Recruiting
Conditions
Gastric Cancer
HER2 Overexpressing Gastric Carcinoma
Interventions
First Posted Date
2021-01-19
Last Posted Date
2023-12-21
Lead Sponsor
RemeGen Co., Ltd.
Target Recruit Count
351
Registration Number
NCT04714190
Locations
🇨🇳

Jilin Provincial Tumor Hospital, Changchun, China

🇨🇳

The Sixth Affiliated Hospital of Sun Yat-sen University, Guangzhou, China

🇨🇳

Zhejiang Cancer Hospital, Hangzhou, China

and more 49 locations

A Study of RC48-ADC for the Treatment of Locally Advanced or Metastatic Breast Cancer With Low Expression of HER2

First Posted Date
2020-05-22
Last Posted Date
2024-01-24
Lead Sponsor
RemeGen Co., Ltd.
Target Recruit Count
366
Registration Number
NCT04400695
Locations
🇨🇳

Oncology Hospital, Chinese Academy of Medical Sciences, Beijing, Beijing, China

A Study of RC48-ADC in Subjects With HER2 Overexpressed Metastatic Biliary Tract Cancer

Phase 2
Active, not recruiting
Conditions
Biliary Tract Cancer
Interventions
First Posted Date
2020-04-01
Last Posted Date
2023-12-20
Lead Sponsor
RemeGen Co., Ltd.
Target Recruit Count
57
Registration Number
NCT04329429
Locations
🇨🇳

Zhongshan Hospital, Fudan University, Shanghai, Shanghai, China

🇨🇳

First Hospital of Jilin University, Chang chun, Jilin, China

🇨🇳

Peking University Cancer Hospital & Institute, Beijing, Beijing, China

and more 13 locations

A Study of RC48-ADC in Subjects With Advanced Non-small Cell Lung Cancer

Phase 1
Completed
Conditions
Non Small Cell Lung Cancer
Interventions
First Posted Date
2020-03-17
Last Posted Date
2023-12-18
Lead Sponsor
RemeGen Co., Ltd.
Target Recruit Count
37
Registration Number
NCT04311034
Locations
🇨🇳

Shanghai Pulmonary Hospital, Shanghai, Shanghai, China

A Study of RC48-ADC in Subjects With HER2-negative Locally Advanced or Metastatic Urothelial Cancer

Phase 2
Completed
Conditions
Urothelial Carcinoma
Interventions
First Posted Date
2019-08-29
Last Posted Date
2023-12-18
Lead Sponsor
RemeGen Co., Ltd.
Target Recruit Count
19
Registration Number
NCT04073602
Locations
🇨🇳

Beijing Cancer Hospital, Beijing, Beijing, China

A Open-label, Single-arm, Multicenter, Phase II Study of RC48-ADC to Evaluate the Efficacy and Safety of Subjects With HER2 Overexpressing Locally Advanced or Metastatic Urothelial Cancer

Phase 2
Completed
Conditions
Urothelial Carcinoma
Interventions
First Posted Date
2019-01-18
Last Posted Date
2023-11-27
Lead Sponsor
RemeGen Co., Ltd.
Target Recruit Count
64
Registration Number
NCT03809013
Locations
🇨🇳

Cancer Hospital Chinese Academy of Medical Sciences, Beijing, Beijing, China

🇨🇳

Hunan Cancer Hospital, Changsha, Hunan, China

🇨🇳

Sun Yat-sen University Cancer Center, Guangzhou, Guangdong, China

and more 5 locations

A Study of RC48-ADC in Local Advanced or Metastatic Gastric Cancer Subjects With the Overexpression of HER2

Phase 2
Completed
Conditions
HER2 Overexpressing Gastric Carcinoma
Gastric Cancer
Interventions
First Posted Date
2018-06-14
Last Posted Date
2022-01-13
Lead Sponsor
RemeGen Co., Ltd.
Target Recruit Count
127
Registration Number
NCT03556345
Locations
🇨🇳

Beijing Cancer Hospital, Beijing, Beijing, China

A Phase II Study of RC48-ADC in Subjects With HER2 Positive Metastatic or Unresectable Urothelial Cancer

Phase 2
Completed
Conditions
Urothelial Carcinoma
Advanced Cancer
Interventions
First Posted Date
2018-04-24
Last Posted Date
2019-08-21
Lead Sponsor
RemeGen Co., Ltd.
Target Recruit Count
43
Registration Number
NCT03507166
Locations
🇨🇳

Beijing Cancer Hospital, Beijing, N/A = Not Applicable, China

🇨🇳

Cancer Hospital Chinese Academy of Medical Sciences, Beijing, N/A = Not Applicable, China

A Study of RC48-ADC Administered Intravenously to Patients With HER2-Positive Metastatic Breast Cancer With or Without Liver Metastases

Phase 2
Active, not recruiting
Conditions
Breast Neoplasms
Breast Diseases
Capecitabine
HER2-positive Breast Cancer
HER2 Positive Breast Carcinoma
HER2-positive Advanced Breast With Liver Metastases
Interventions
First Posted Date
2018-04-18
Last Posted Date
2024-02-20
Lead Sponsor
RemeGen Co., Ltd.
Target Recruit Count
301
Registration Number
NCT03500380
Locations
🇨🇳

Liaoning Cancer Hospital & Institute, Shenyang, Liaoning, China

🇨🇳

Peking University People's Hospital, Beijing, China

🇨🇳

The First Affiliated Hospital of Bengbu Medical College, Bengbu, China

and more 64 locations

A Study of RC48-ADC in Subjects With HER2-Positive Advanced Malignant Solid Tumors

Phase 1
Completed
Conditions
Solid Tumors
Interventions
First Posted Date
2016-08-26
Last Posted Date
2020-07-30
Lead Sponsor
RemeGen Co., Ltd.
Target Recruit Count
24
Registration Number
NCT02881138
Locations
🇨🇳

Cancer Hospital Chinese Academy of Medical Sciences, Beijing, Beijing, China

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