RC48-ADC in Adjuvant/Salvage Treatment of HER2 Positive Non-muscle-invasive Bladder Cancer
NCT ID: NCT05996952
Last Updated: 2023-08-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
PHASE2
77 participants
INTERVENTIONAL
2023-08-31
2026-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Adjuvant RC48-ADC
In this arm, RC48-ADC is evaluated in patients with HER2-positive high-risk non-muscle-invasive bladder cancer as an adjuvant treatment.
RC48-ADC
Patients are treated with RC48-ADC at 2.0 mg/kg as an intravenous infusion over 30-90 minutes (60 minutes is recommended) once every 2 weeks for 12 weeks.
Salvage RC48-ADC
In this arm, RC48-ADC is evaluated in patients with HER2-positive non-muscle-invasive bladder cancer who failed BCG treatment as an adjuvant treatment.
RC48-ADC
Patients are treated with RC48-ADC at 2.0 mg/kg as an intravenous infusion over 30-90 minutes (60 minutes is recommended) once every 2 weeks for 12 weeks.
Interventions
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RC48-ADC
Patients are treated with RC48-ADC at 2.0 mg/kg as an intravenous infusion over 30-90 minutes (60 minutes is recommended) once every 2 weeks for 12 weeks.
Eligibility Criteria
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Inclusion Criteria
* Life expectancy ≥12 weeks.
* Have a histologically-confirmed diagnosis of high-risk non-muscle-invasive (according to 2023 NCCN guidelines for bladder cancer) transitional cell carcinoma of the bladder. Subjects with tumors of mixed transitional/non-transitional cell histology are allowed, but transitional cell carcinoma must be the predominant histology.
* Have been treated with adequate BCG therapy and failed (according to 2023 EAU guidelines for NMIBC, for salvage treatment arm).
* Have elected not to undergo, or are considered ineligible for radical cystectomy, as determined by the treating surgeon.
* Have tumor tissues for HER2 IHC evaluation and have a HER2 expression score of HER2 2+ or HER2 3+ reviewed by an independent pathologist at the central laboratory.
* Have a performance status of 0, 1 or 2 on the Eastern Cooperative Oncology Group (ECOG) Performance Scale.
* Demonstrate adequate organ function.
* Female subjects of childbearing potential must have a negative urine or serum pregnancy test within 7 days prior to receiving the first dose of study medication.
* Male subjects of childbearing potential (Section 5.7.2) must agree to use an adequate method of contraception starting with the first dose of study therapy through 6 months after the last dose of study therapy.
Exclusion Criteria
* Has concurrent extra-vesical (i.e. urethra, ureter or renal pelvis) non-muscle invasive transitional cell carcinoma of the urothelium.
* Is currently participating and receiving study therapy or has participated in a study of an investigational agent and received study therapy or used an investigational device within 4 weeks of the first dose of treatment.
* Has undergone any intervening intravesical chemotherapy or immunotherapy from the time of most recent cystoscopy/TURBT to starting trial treatment. (Note: A single dose of intravesical treatment given as part of the most recent cystoscopy/TURBT, during the screening period, such as with chemotherapy as per local / regional practices, is acceptable.).
* Allergic to study therapy.
* Has a known additional malignancy that has had progression or has required active treatment in the last five years.
* Has an active autoimmune disease that has required systemic treatment in past 2 years.
* Have diseases that may interfere with the study treatment or severe and uncontrolled concomitant diseases.
* Has had an allogeneic tissue/solid organ transplant.
18 Years
75 Years
ALL
No
Sponsors
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RemeGen Co., Ltd.
INDUSTRY
West China Hospital
OTHER
Responsible Party
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Hao Zeng
Professor
Principal Investigators
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Hao Zeng
Role: PRINCIPAL_INVESTIGATOR
West China Hospital
Locations
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West China Hospital
Chengdu, Sichuan, China
Countries
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Central Contacts
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Other Identifiers
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2023(24)
Identifier Type: -
Identifier Source: org_study_id
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