A Study of RC48-ADC in Subjects With HER2-negative Locally Advanced or Metastatic Urothelial Cancer
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04073602|
Recruitment Status : Recruiting
First Posted : August 29, 2019
Last Update Posted : June 2, 2020
|Condition or disease||Intervention/treatment||Phase|
|Urothelial Carcinoma||Drug: RC48-ADC||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||18 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||An Open-label, Single-arm, Single-center, Phase II Study to Evaluate the Efficacy and Safety of Recombinant Humanized Anti-HER2 Monoclonal Antibody-MMAE Conjugate for Injection in Subjects With HER2-negative Metastatic or Unresectable Urothelial Cancer|
|Actual Study Start Date :||August 19, 2019|
|Estimated Primary Completion Date :||June 30, 2020|
|Estimated Study Completion Date :||October 31, 2020|
Participants will be treated with RC48-ADC 2.0 mg/kg, once every 2 weeks (Q2W) until investigator-assessed loss of clinical benefit, unacceptable toxicity, investigator or participant's decision to withdraw from therapy, or death (whichever occurs first).
The eligible patients will be treated with RC48-ADC, an antibody-drug conjugate, 2.0 mg/kg, once every two weeks until investigator-assessed loss of clinical benefit, unacceptable toxicity, investigator or participant's decision to withdraw from therapy, or death (whichever occurs first).
Other Name: Recombinant Humanized anti-HER2 Monoclonal Antibody-MMAE Conjugate For Injection
- Objective Response Rate (ORR)as assessed by Investigator [ Time Frame: 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) [ Time Frame: 24 months ]Tumor response was assessed by investigator according to RECIST v1.1
- Duration of Objective Response (DOR) [ Time Frame: 24 months ]DOR was defined as the time from first documented OR to first documented PD or death from any cause, whichever occurred earlier
- Disease control rate (DCR) [ Time Frame: 24 months ]DCR was defined as the proportion of patients who achieved an objective response or maintained stable disease during the study
- 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.
- Adverse Events [ Time Frame: 28 days after the last dose of study treatment ]Incidence of Adverse Events
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): NCT04073602
|Contact: Jianmin Fangfirstname.lastname@example.org|
|Beijing Cancer Hospital||Recruiting|
|Beijing, Beijing, China, 100078|
|Contact: Jun Guo, M.D.|