A Phase II Study of RC48-ADC in Subjects With HER2 Positive Metastatic or Unresectable Urothelial Cancer
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|ClinicalTrials.gov Identifier: NCT03507166|
Recruitment Status : Completed
First Posted : April 24, 2018
Last Update Posted : June 26, 2019
|Condition or disease||Intervention/treatment||Phase|
|Urothelial Carcinoma Advanced Cancer||Drug: RC48-ADC||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||43 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||Drug: RC48-ADC|
|Masking:||None (Open Label)|
|Official Title:||A Multicenter, Open Label，Single Arm，Phase II Study to Evaluate the Effect and Safety of Recombinant Humanized Anti-HER2 Monoclonal Antibody-MMAE Conjugate For Injection in Subjects With HER2 Positive Metastatic or Unresectable Urothelial Cancer|
|Actual Study Start Date :||December 28, 2017|
|Actual Primary Completion Date :||October 29, 2018|
|Actual Study Completion Date :||October 29, 2018|
Participants will receive RC48-ADC every 2 weeks (Q2W) until investigator assessed loss of clinical benefit, unacceptable toxicity, investigator or participant decision to withdraw from therapy, or death (whichever occurs first).
2 mg/kg IV every 2 weeks
Other Name: Recombinant Humanized anti-HER2 Monoclonal Antibody-MMAE Conjugate For Injection
- Objective Response Rate （ORR） [ Time Frame: up to 24 months ]Objective Response Rate was defined as the percentage of participants with a complete response (CR) or partial response (PR)
- Progression Free Survival (PFS) as Assessed by investigator [ Time Frame: up to 24 months ]Tumor response was assessed by investigator according to RECIST v1.1
- Duration of Objective Response (DOR) [ Time Frame: up to 24 months ]DOR was defined as the time from first documented OR to first documented PD or death from any cause, whichever occurred earlier
- Overall Survival(OS) [ Time Frame: up to 24 months ]OS was defined as the time from the first study treatment to the date of death from any cause
- ORR of HER2-positive patients [ Time Frame: up to 24 months ]ORR of HER2-Positive patients was defined as the percentage of HER2-positive participants with a complete response (CR) or partial response (PR).
- Disease control rate (DCR) [ Time Frame: up to 24 months ]DCR was defined as the proportion of patients who achieved an objective response or maintained stable disease during the study.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03507166
|China, N/A = Not Applicable|
|Beijing Cancer Hospital|
|Beijing, N/A = Not Applicable, China, 100078|
|Cancer Hospital Chinese Academy of Medical Sciences|
|Beijing, N/A = Not Applicable, China|