- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04073602
A Study of RC48-ADC in Subjects With HER2-negative Locally Advanced or Metastatic Urothelial Cancer
December 15, 2023 updated by: RemeGen Co., Ltd.
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
This study will evaluate the efficacy and safety of intravenous RC48-ADC in patients with locally advanced or metastatic HER2-negative urothelial cancer.
Study Overview
Study Type
Interventional
Enrollment (Actual)
19
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
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Beijing
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Beijing, Beijing, China, 100078
- Beijing Cancer Hospital
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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
Description
Inclusion Criteria:
- Voluntary agreement to provide written informed consent.
- Male or female, Age ≥ 18 years.
- Predicted survival ≥ 12 weeks.
- Diagnosed with histologically or cytologically-confirmed locally advanced or metastatic urothelial cancer, originate from bladder, renal pelvis, ureter and urinary tract.
- Unresectable or disease progression (i.e. locally advanced/metastasis) after surgery and at least regular chemotherapy including gemcitabine, cisplatin AND paclitaxel. Disease progression within 6 months of the completion of neo-adjuvant and adjuvant chemotherapy with gemcitabine, cisplatin AND paclitaxel is also eligible.
- Measurable lesion according to RECIST 1.1.
- HER2 negative (i.e. IHC -or 1+) as confirmed by the department of Pathology in Beijing Cancer Hospital. Subject is able to provide specimens from primary or metastatic lesions for HER2 tests.
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1.
- Adequate organ function, evidenced by the following laboratory results within 7 days prior to the study treatment:
Cardiac ejection fraction ≥ 50 %. Hemoglobin ≥ 9g/dL; Absolute neutrophil count ≥ 1.5×10^9/L Platelets ≥ 100×10^9/L; Total bilirubin ≤ 1.5× ULN; AST and ALT ≤ 2.5×ULN and ≤ 5 x ULN with hepatic metastasis; Serum creatinine ≤1.5×ULN.
- 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 the components of Recombinant Humanized Anti-HER2 Monoclonal Antibody-MMAE Conjugate.
- Toxicity of previous anti-tumor treatment not recovered to CTCAE Grade 0-1 (with exception of Grade 2 alopecia).
- Pleural or abdominal effusion with clinical symptoms that requires ongoing treatment.
- History of receiving any anti-cancer drug/biologic treatment within 3 weeks prior to trial treatment.
- 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.
- Diagnosed with HBsAg , HBcAb positive and HBV DNA copy positive, or HCVAb positive.
- 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 3 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.
- Uncontrolled hypertension, diabetes, Interstitial lung Disease, or COPD;
- Treated with systemic treatment (e.g. immunomodulators, corticosteroids or immunosuppressants) for the autoimmune disease within 2 years prior to the study treatment.
- NYHA Class III heart failure
- 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: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: RC48-ADC
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).
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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 Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Objective Response Rate (ORR)as assessed by Investigator
Time Frame: 24 months
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Objective Response Rate was defined as the percentage of participants with a complete response (CR) or partial response (PR)
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24 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Duration of Objective Response (DOR)
Time Frame: 24 months
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DOR was defined as the time from first documented OR to first documented PD or death from any cause, whichever occurred earlier
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24 months
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Adverse Events
Time Frame: 28 days after the last dose of study treatment
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Incidence of Adverse Events
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28 days after the last dose of study treatment
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Progression Free Survival (PFS)
Time Frame: 24 months
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Tumor response was assessed by investigator according to RECIST v1.1
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24 months
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Disease control rate (DCR)
Time Frame: 24 months
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DCR was defined as the proportion of patients who achieved an objective response or maintained stable disease during the study
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24 months
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Overall Survival(OS)
Time Frame: up to 24 months
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OS was defined as the time from the first study treatment to the date of death from any cause.
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up to 24 months
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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)
August 19, 2019
Primary Completion (Actual)
September 30, 2022
Study Completion (Actual)
January 31, 2023
Study Registration Dates
First Submitted
August 27, 2019
First Submitted That Met QC Criteria
August 27, 2019
First Posted (Actual)
August 29, 2019
Study Record Updates
Last Update Posted (Actual)
December 18, 2023
Last Update Submitted That Met QC Criteria
December 15, 2023
Last Verified
December 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- RC48-C011
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.
Clinical Trials on Urothelial Carcinoma
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Alliance for Clinical Trials in OncologyNational Cancer Institute (NCI)Active, not recruitingMetastatic Bladder Urothelial Carcinoma | Metastatic Renal Pelvis Urothelial Carcinoma | Metastatic Ureter Urothelial Carcinoma | Metastatic Urethral Urothelial Carcinoma | Metastatic Urothelial Carcinoma | Locally Advanced Bladder Urothelial Carcinoma | Locally Advanced Renal Pelvis Urothelial... and other conditionsUnited States
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Roswell Park Cancer InstituteIovance Biotherapeutics, Inc.WithdrawnMetastatic Bladder Urothelial Carcinoma | Metastatic Renal Pelvis Urothelial Carcinoma | Metastatic Ureter Urothelial Carcinoma | Metastatic Urethral Urothelial Carcinoma | Unresectable Renal Pelvis Urothelial Carcinoma | Unresectable Ureter Urothelial CarcinomaUnited States
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University of UtahNational Cancer Institute (NCI)RecruitingMetastatic Urothelial Carcinoma | Locally Advanced Urothelial Carcinoma | Unresectable Urothelial Carcinoma | Infiltrating Urothelial Carcinoma, Sarcomatoid VariantUnited States
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National Cancer Institute (NCI)Active, not recruitingMetastatic Urothelial Carcinoma | Stage III Bladder Urothelial Carcinoma AJCC v6 and v7 | Stage IV Bladder Urothelial Carcinoma AJCC v7 | Locally Advanced Urothelial Carcinoma | Recurrent Urothelial Carcinoma | Unresectable Urothelial Carcinoma | Advanced Urothelial CarcinomaUnited States
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Emory UniversityNational Cancer Institute (NCI); ExelixisRecruitingMetastatic Urothelial Carcinoma | Locally Advanced Urothelial Carcinoma | Unresectable Urothelial Carcinoma | Infiltrating Bladder Urothelial Carcinoma With Squamous DifferentiationUnited States
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Mamta ParikhNational Cancer Institute (NCI); Karyopharm Therapeutics IncRecruitingMetastatic Urothelial Carcinoma | Locally Advanced Urothelial Carcinoma | Advanced Urothelial Carcinoma | Refractory Urothelial CarcinomaUnited States
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M.D. Anderson Cancer CenterNational Cancer Institute (NCI)Active, not recruitingMetastatic Urothelial Carcinoma | Infiltrating Bladder Urothelial Carcinoma, Plasmacytoid Variant | Infiltrating Bladder Urothelial Carcinoma Sarcomatoid Variant | Infiltrating Bladder Urothelial Carcinoma With Glandular Differentiation | Infiltrating Bladder Urothelial Carcinoma With Squamous... and other conditionsUnited States
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National Cancer Institute (NCI)Active, not recruitingMetastatic Bladder Urothelial Carcinoma | Metastatic Ureter Urothelial Carcinoma | Stage IV Bladder Urothelial Carcinoma AJCC v7 | Metastatic Renal Pelvis and Ureter Urothelial CarcinomaUnited States
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Mayo ClinicNational Cancer Institute (NCI)WithdrawnInfiltrating Bladder Urothelial Carcinoma | Stage II Bladder Urothelial Carcinoma | Stage IV Bladder Urothelial Carcinoma | Stage III Bladder Urothelial CarcinomaUnited States
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University of Southern CaliforniaNational Cancer Institute (NCI)TerminatedStage II Bladder Urothelial Carcinoma | Stage III Bladder Urothelial Carcinoma | Stage 0is Bladder Urothelial Carcinoma | Stage I Bladder Urothelial CarcinomaUnited States
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