2026-525531-16-00招募中3 期
A Randomized Phase III Study to Investigate the Efficacy and Safety of Alpha1H as a Neoadjuvant Therapy in Participants with Low- to Intermediate-Risk/Low-Grade Papillary Non-Muscle Invasive Bladder Cancer
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 169
- 试验地点
- 1
- 主要终点
- Event-Free Survival is defined as the time from randomization to the earliest occurrence of: i) Recurrence of NMIBC (any grade or stage), ii) Progression to muscle-invasive bladder cancer (MIBC), iii) Development of metastatic bladder cancer, iv) Death from any cause
研究概览
简要总结
The primary objective is to determine whether neoadjuvant intravesical Alpha1H administered prior to standard TURBT-based management improves Event-Free Survival (EFS) compared with standard TURBT-based management alone in patients with low- to intermediate-risk NMIBC.
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 否
入选标准
- •Signed and dated informed consent.
- •Patient with low- to intermediate-risk (in low and intermediate risk subgroup according to IBCG subclassification) non-muscle invasive papillary bladder cancer (NMIBC).
- •Male and female subjects, 18 years or older.
- •Negative pregnancy test in women of childbearing potential.
- •Women of childbearing potential must agree to use appropriate highly effective methods of contraception during the study in compliance with the protocol requirements; fertile men must refrain from donating sperm.
- •Patients should be able to keep the content of the bladder for two hours.
排除标准
- •Patient with non-papillary tumor appearance at the time of initial cystoscopy
- •WHO performance status 3 or
- •Any other investigational agent or non-marketed product within one month prior to Visit 1 and during the trial.
- •Known active HIV infection, defined as detectable HIV viral load at screening.
- •Active hepatitis B virus (HBV) infection, defined as hepatitis B surface antigen (HBsAg) positivity with detectable HBV DNA at screening.
- •Active hepatitis C virus (HCV) infection, defined as anti-HCV antibody positivity with detectable HCV RNA at screening in a patient not on stable antiviral treatment.
- •Any concurrent illness that may render a participant ineligible or limit compliance with study requirements.
- •Previously enrolled in this trial.
- •Previous history of T1 or high-grade disease in recurrent tumors.
- •Patient with T1 or high-grade non-muscle invasive papillary bladder cancer (NMIBC).
- •Previous intravesical BCG immunotherapy.
- •Participants with any other cancer diagnosis within the last 5 years (except for skin basalioma).
- •Acute urinary tract infection requiring antibiotic treatment.
- •Prior radiotherapy or systemic chemotherapy.
结局指标
主要结局
Event-Free Survival is defined as the time from randomization to the earliest occurrence of: i) Recurrence of NMIBC (any grade or stage), ii) Progression to muscle-invasive bladder cancer (MIBC), iii) Development of metastatic bladder cancer, iv) Death from any cause
Event-Free Survival is defined as the time from randomization to the earliest occurrence of: i) Recurrence of NMIBC (any grade or stage), ii) Progression to muscle-invasive bladder cancer (MIBC), iii) Development of metastatic bladder cancer, iv) Death from any cause
次要结局
- CR rate in the Alpha1H arm compared to SOC.
- Overall Survival in Alpha1H arm compared to SOC.
- Tumor response to Alpha1H based on change in tumor size, cell numbers in urine, properties of shed tumor cells and induction of apoptosis.
- Tumor response defined by cancer-related gene expression in tissue samples and urine RNA.
- Protein biomarkers/immune response to Alpha1H in the urine of patients pre- and post-Alpha1H treatment.
- Correlation between tumor cell shedding and recurrence or CR failure in study population.
- Tissue accumulation of Alpha1H.
- Safety and tolerability of Alpha1H.
- Incidence and severity of treatment-emergent adverse events (AEs) and complications attributable to intravesical instillation of Alpha 1H (dysuria, urinary frequency/urgency, urinary retention, hematuria).
- Quality of Life (QOL) changes based on Patient-Reported-Outcomes (QLQ-NMIBC24]) from baseline to follow-up visit.
研究者
Catharina Svanborg
Scientific
Hamlet BioPharma AB
研究点 (1)
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