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Trial Title:
RC48-ADC in Adjuvant/Salvage Treatment of HER2 Positive Non-muscle-invasive Bladder Cancer
NCT ID:
NCT05996952
Condition:
Non-muscle Invasive Bladder Cancer
Conditions: Official terms:
Urinary Bladder Neoplasms
Non-Muscle Invasive Bladder Neoplasms
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Not yet recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
RC48-ADC
Description:
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.
Arm group label:
Adjuvant RC48-ADC
Arm group label:
Salvage RC48-ADC
Summary:
This study will evaluate the efficacy and safety of intravenous RC48-ADC in
adjuvant/salvage treatment of HER2 positive high-risk non-muscle-invasive bladder cancer.
Detailed description:
This study is a multicenter phase II study, which aims to evaluate the efficacy and
safety of intravenous RC48-ADC in adjuvant/salvage treatment of HER2 positive high-risk
non-muscle-invasive bladder cancer.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Be willing and able to provide written informed consent/assent for the trial.
- 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 muscle-invasive (i.e. T2, T3, T4) locally advanced non-resectable or metastatic
urothelial carcinoma.
- 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.
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
West China Hospital
Address:
City:
Chengdu
Zip:
610041
Country:
China
Start date:
August 2023
Completion date:
August 2026
Lead sponsor:
Agency:
West China Hospital
Agency class:
Other
Collaborator:
Agency:
RemeGen Co., Ltd.
Agency class:
Industry
Source:
West China Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05996952
