A 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
2026년 8월 31일 업데이트: Hamlet Pharma AB
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
The goal of this clinical trial is to learn if the drug Alpha1H works to treat low-to-intermediate risk non-muscle-invasive bladder cancer in adults. It will also learn about the safety of drug Alpha1H.
The main questions it aims to answer are:
- Does giving drug Alpha1H before surgery lower the risk of cancer returning or worsening compared to standard care alone?
- Is drug Alpha1H safe and well-tolerated by participants? Researchers will compare participants receiving drug Alpha1H before standard surgery to participants receiving standard care alone to see if drug Alpha1H lowers the risk of cancer returning or progressing.
Participants will:
- Be randomly assigned to receive either drug Alpha1H before surgery or standard care alone.
- Receive drug Alpha1H directly into the bladder 6 times over about 1 month if assigned to the Alpha1H group.
- Hold the liquid in the bladder for up to 2 hours during each visit.
- Undergo standard surgery through the urethra (TURBT) to remove remaining tumor tissue.
- Visit the clinic regularly for follow-up checkups (including bladder examinations and urine tests) to check if the cancer returns.
- Fill out questionnaires about their quality of life.
연구 개요
상태
아직 모집하지 않음
연구 유형
중재적
등록 (추정된)
194
단계
- 3단계
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 연락처
- 이름: Catharina Svanborg, MD, PhD.
- 전화번호: +46709426549
- 이메일: catharina.svanborg@med.lu.se
연구 연락처 백업
- 이름: Petr Bouska
- 전화번호: +420773076076
- 이메일: pe.bouska@gmail.com
연구 장소
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Prague, 체코, 15000
- Fakultní nemocnice Motol a Homolka
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
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- 고령자
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아니
설명
Inclusion Criteria:
- Signed and dated informed consent.
- Low- or intermediate-risk non-muscle-invasive bladder cancer (NMIBC) meeting one of the following definitions:
- Low-risk NMIBC: Primary, solitary, Ta, low-grade, 0.5 cm to 3 cm.
- Intermediate-risk NMIBC (low-to-intermediate risk subgroup per IBCG classification):
- Primary multifocal (<10 lesions), Ta, low-grade, 0.5 cm to 3 cm;
- Recurrent solitary, Ta, low-grade, 0.5 cm to 3 cm; or
- Recurrent multifocal (<10 lesions), Ta, low-grade, >1 year after previous recurrence.
- Men and women aged 18 years or older.
- Negative pregnancy test at screening for women of childbearing potential.
- Women of childbearing potential must agree to use highly effective contraception methods throughout study participation; men of childbearing potential must refrain from donating sperm during the study.
- Ability to retain bladder contents for 2 hours.
Exclusion Criteria:
- Patient with non-papillary tumor appearance at the time of initial cystoscopy.
- Previous history of T1 or high-grade disease in recurrent tumors.
- Patients with T1 or high-grade non-muscle invasive papillary bladder cancer (NMIBC).
- Previous intravesical BCG immunotherapy.
- Patients 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.
- WHO performance status of 3 or 4.
- 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.
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: Alpha1H
Participants receive 6 intravesical instillations of Alpha1H over approximately 1 month prior to transurethral resection of bladder tumor (TURBT).
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Administered via intravesical instillation directly into the urinary bladder.
Participants in the experimental group receive a total of 6 instillations on Days 1, 3, 5, 8, 15, and 22 over approximately 1 month prior to TURBT.
During each treatment, participants are asked to retain the solution in the bladder for up to 2 hours.
Standard endoscopic surgical procedure performed through the urethra to resect and remove papillary bladder tumor tissue.
Performed approximately 30 days after study entry (on Visit 8).
Resected tumor tissue is collected for histopathology and central analysis.
A single early intravesical instillation of standard-of-care chemotherapy (epirubicin, mitomycin, or gemcitabine) administered into the urinary bladder shortly following TURBT surgery in accordance with local institutional guidelines.
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활성 비교기: Standard of Care
Participants receive standard of care consisting of transurethral resection of bladder tumor (TURBT) followed by a single early intravesical instillation of standard chemotherapy.
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Standard endoscopic surgical procedure performed through the urethra to resect and remove papillary bladder tumor tissue.
Performed approximately 30 days after study entry (on Visit 8).
Resected tumor tissue is collected for histopathology and central analysis.
A single early intravesical instillation of standard-of-care chemotherapy (epirubicin, mitomycin, or gemcitabine) administered into the urinary bladder shortly following TURBT surgery in accordance with local institutional guidelines.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
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Event-Free Survival (EFS)
기간: From randomization until the occurrence of an EFS event or study completion, assessed at 3, 6, 9 (optional), and 12 months post-randomization, and every 6 months thereafter for up to 3 years.
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From randomization until the occurrence of an EFS event or study completion, assessed at 3, 6, 9 (optional), and 12 months post-randomization, and every 6 months thereafter for up to 3 years.
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Complete Response (CR) Rate
기간: Day 30 (±5 days), prior to TURBT
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Day 30 (±5 days), prior to TURBT
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Overall Survival (OS)
기간: From randomization through study completion (assessed at 3, 6, 9 [optional], and 12 months, and every 6 months thereafter for up to 3 years).
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From randomization through study completion (assessed at 3, 6, 9 [optional], and 12 months, and every 6 months thereafter for up to 3 years).
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Tumor Response (Morphological and Cellular)
기간: Baseline (Day 1) to Day 30 (±5 days)
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Assessed as: (1) change in papillary tumor size (% reduction from baseline); (2) tumor cell shedding in urine (cells/mL); (3) apoptosis in shed cells (% TUNEL-positive cells); (4) Alpha1H uptake in shed cells (% Alpha1H-positive cells).
Each parameter reported separately.
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Baseline (Day 1) to Day 30 (±5 days)
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Tumor Gene Expression
기간: Baseline (Day 1) to Day 30 (±5 days)
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Assessed by RNA sequencing (whole transcriptome) in tumor tissue and urine RNA.
Reported as number of differentially expressed cancer-related genes and pathways between the Alpha1H and SOC arms.
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Baseline (Day 1) to Day 30 (±5 days)
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Urinary Biomarkers and Immune Response
기간: Day 1, 3, 5, 8, 15, and 22 (pre- and post-instillation), and Day 30 (±5 days)
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Assessed by proteomic profiling of urine samples.
Reported as change in concentration (pg/mL) of cytokines, chemokines, and interferons between pre- and post-instillation samples, compared between the Alpha1H and SOC arms.
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Day 1, 3, 5, 8, 15, and 22 (pre- and post-instillation), and Day 30 (±5 days)
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Incidence and Severity of Adverse Events (AEs)
기간: From Visit 1 (Screening) through Visit 9 (Day 40/50) and follow-up period (up to 3 years)
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From Visit 1 (Screening) through Visit 9 (Day 40/50) and follow-up period (up to 3 years)
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Change in Quality of Life (QoL) as Assessed by the QLQ-NMIBC24 Questionnaire
기간: From Visit 1 (Screening) through follow-up visits (up to 3 years)
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Quality of life will be assessed using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Non-Muscle-Invasive Bladder Cancer Module (EORTC QLQ-NMIBC24), a 24-item, disease-specific patient-reported outcome instrument.
Each domain score is linearly transformed to range from 0 to 100.
On functional scales (e.g., sexual function), higher scores indicate better functioning; on symptom-related scales (e.g., urinary symptoms, future perspective), higher scores indicate greater symptom burden.
Scores are calculated per the EORTC scoring manual.
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From Visit 1 (Screening) through follow-up visits (up to 3 years)
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여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
스폰서
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (추정된)
2026년 9월 1일
기본 완료 (추정된)
2029년 7월 1일
연구 완료 (추정된)
2029년 7월 1일
연구 등록 날짜
최초 제출
2026년 8월 26일
QC 기준을 충족하는 최초 제출
2026년 8월 31일
처음 게시됨 (실제)
2026년 9월 4일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2026년 9월 4일
QC 기준을 충족하는 마지막 업데이트 제출
2026년 8월 31일
마지막으로 확인됨
2026년 8월 1일
추가 정보
이 연구와 관련된 용어
키워드
추가 관련 MeSH 약관
기타 연구 ID 번호
- HP003-001
- 2026-525531-16-00 (씨티스)
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
미정
약물 및 장치 정보, 연구 문서
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예
미국 FDA 규제 기기 제품 연구
아니
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