Non-muscle Invasive Bladder Cancer
Conditions
Brief 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.
Interventions
DRUGRC48-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.
Sponsors
RemeGen Co., Ltd.
West China Hospital
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 12-month recurence-free survival rate | From treatment initiation to 12 month | The probability of patients remaining free of high-risk NMIBC or worse for at least 12 months after first dose of RC48-ADC adjuvant treatment |
| 3-month pathological complete response rate | From treatment initiation to 3 month | The proportion of patients are negative for urine cytology and cystoscopy at 3 month after first dose of RC48-ADC salvage treatment |
| Adverse events | From patient screening to 30 days after end of cycle 6 | The type, incidence, relatedness, and severity of adverse events |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Progression-free survival | From time of first dose of RC48-ADC treatment to up to 60 months | Time from first dose of RC48-ADC treatment to progression to higher stage or death |
| 6-month recurence-free survival rate | From treatment initiation to 6 month | The probability of patients remaining free of high-risk NMIBC or worse for at least 6 months after first dose of RC48-ADC adjuvant treatment |
| Quality of life assessed by EQ-5D scale | After every cycle of treatment and 30 days after end of cycle 6 | Assessed by eEuroQoL EQ-5D scale, higher scores mean better outcomes |
| Overall survival | From time of first dose of RC48-ADC treatment to up to 60 months | Time from first dose of RC48-ADC treatment to death from any cause |
| Duration of response | From time of complete response to up to 60 months | Time from complete response to recurrence of any disease |
| Recurrence-free survival | From time of first dose of RC48-ADC adjuvant treatment to up to 60 months | Time from first dose of RC48-ADC adjuvant treatment to high-risk NMIBC recurrence or worse |
Countries
China
Contacts
Primary ContactHao Zeng
Backup ContactJunru Chen
Outcome results
None listed