- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03507166
A Phase II Study of RC48-ADC in Subjects With HER2 Positive Metastatic or Unresectable Urothelial Cancer
August 20, 2019 updated by: RemeGen Co., Ltd.
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
This study will evaluate the efficacy and safety of intravenous RC48-ADC in patients with local advanced or metastatic HER2 positive endothelial cancer.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
43
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
N/A = Not Applicable
-
Beijing, N/A = Not Applicable, China, 100078
- Beijing Cancer Hospital
-
Beijing, N/A = Not Applicable, China
- Cancer Hospital Chinese Academy of Medical Sciences
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 80 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Voluntary agreement to provide written informed consent.
- Male or female, Age ≥ 18 years and < 80 years.
- Predicted survival ≥ 12 weeks.
- Have histologically or cytologically-confirmed diagnosis of inoperable, locally advanced or metastatic urothelial cancer of the bladder, renal pelvis, ureter.
- Have had progression or intolerance following receipt of at least one systemic chemotherapy for advanced or metastatic disease.
- Measurable disease according to RECIST 1.1.
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1.
- HER2-positive status confirmed by the central laboratory: IHC 2+ or 3+; Subject is able to provide specimens from primary or metastatic lesions for HER2 tests
- Adequate organ function, evidenced by the following laboratory results:
Cardiac ejection fraction ≥ 50 %. Hemoglobin ≥ 9g/dL; Absolute neutrophil count ≥ 1.5×109 /L Platelets ≥ 100×109 /L; Total bilirubin ≤ 1.5× ULN; Without liver metastasis: ALT and AST ≤ 2.5 x ULN; With liver metastasis: ALT and AST ≤ 5 x ULN; Serum creatinine ≤1.5×ULN or creatinine clearance (CrCl) ≥ 50 mL/min as calculated by the Cockcroft-Gault equation.
- All female subjects will be considered to be of child-bearing potential unless they are postmenopausal, or have been sterilized surgically.Female subjects of child-bearing potential must agree to use two forms of highly effective contraception. Male subjects and their female partner who are of child-bearing potential must agree to use two forms of highly effective contraception.
- Willing to adhere to the study visit schedule and the prohibitions and restrictions specified in this protocol.
Exclusion Criteria:
- Known hypersensitivity to Recombinant Humanized Anti-HER2 Monoclonal Antibody-MMAE Conjugate For Injection.
- History of receiving any anti-cancer drug/biologic treatment within 4 weeks prior to trial treatment.
- History of receiving Recombinant Humanized Anti-HER2 Monoclonal Antibody-MMAE Conjugate For Injection.
- History of major surgery within 4 weeks of planned start of trial treatment.
- Has received a live virus vaccine within 4 weeks of planned start of trial treatment.
- Currently known active infection with HIV or tuberculosis.
- Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the subject's participation for the full duration of the trial, or is not in the best interest of the subject to participate, in the opinion of the treating investigator.
- History of other malignancy within the previous 5 years, except for appropriately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, or cancers with a similar curative outcome as those mentioned above.
- known central nervous system metastases.
- Pregnancy or lactation.
- Assessed by the investigator to be unable or unwilling to comply with the requirements of the protocol.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: RC48-ADC
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 Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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)
|
up to 24 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
up to 24 months
|
Adverse Events
Time Frame: 28 days after the last dose of study treatment
|
Incidence of Adverse Events
|
28 days after the last dose of study treatment
|
ORR of HER2-positive patients
Time Frame: up to 24 months
|
Tumor response was assessed by investigator according to RECIST v1.1
|
up to 24 months
|
Progression Free Survival (PFS)
Time Frame: up to 24 months
|
Tumor response was assessed by investigator according to RECIST v1.1
|
up to 24 months
|
Duration of 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
|
up to 24 months
|
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
|
up to 24 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
December 28, 2017
Primary Completion (ACTUAL)
October 29, 2018
Study Completion (ACTUAL)
October 29, 2018
Study Registration Dates
First Submitted
April 8, 2018
First Submitted That Met QC Criteria
April 14, 2018
First Posted (ACTUAL)
April 24, 2018
Study Record Updates
Last Update Posted (ACTUAL)
August 21, 2019
Last Update Submitted That Met QC Criteria
August 20, 2019
Last Verified
August 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- RC48-C005
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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