Clinical trial NCT05996952: RC48-ADC in Adjuvant/Salvage Treatment of HER2 Positive Non-muscle-invasive Bladder Cancer
Official title: A Multicenter Phase II Study of RC48-ADC in Adjuvant/Salvage Treatment of HER2 Positive High-risk Non-muscle-invasive Bladder Cancer
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
Conditions: Non-muscle Invasive Bladder Cancer
Lead sponsor: West China Hospital
Sponsor class: OTHER
Collaborators: name: RemeGen Co., Ltd.
First posted: 2023-08-18
Enrollment: 77
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: 12-month recurence-free survival rate
timeFrame: From treatment initiation to 12 month
measure: 3-month pathological complete response rate
timeFrame: From treatment initiation to 3 month
measure: Adverse events
timeFrame: From patient screening to 30 days after end of cycle 6
Secondary outcomes:
measure: 6-month recurence-free survival rate
timeFrame: From treatment initiation to 6 month
measure: Duration of response
timeFrame: From time of complete response to up to 60 months
measure: Recurrence-free survival
timeFrame: From time of first dose of RC48-ADC adjuvant treatment to up to 60 months
measure: Progression-free survival
timeFrame: From time of first dose of RC48-ADC treatment to up to 60 months
measure: Overall survival
timeFrame: From time of first dose of RC48-ADC treatment to up to 60 months
measure: Quality of life assessed by EQ-5D scale
timeFrame: After every cycle of treatment and 30 days after end of cycle 6
Other outcomes:
Locations:
city: Chengdu
country: China
facility: West China Hospital
state: Sichuan
Study officials:
affiliation: West China Hospital
name: Hao Zeng
role: PRINCIPAL_INVESTIGATOR
References: