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A Phase 1 Dose-escalation Study of UGN-501 Administered Intravesically in Adult Participants With Recurrent NMIBC

2026년 7월 21일 업데이트: UroGen Pharma, Inc., a subsidiary of UroGen Pharma Ltd.

A Phase 1, Open-label, Dose-escalation Study to Investigate the Safety, Tolerability, and Pharmacokinetics of UGN-501 Administered Intravesically in Adult Participants With Recurrent Non-muscle Invasive Bladder Cancer (NMIBC)

This study is being conducted to evaluate the safety and tolerability of UGN-501 administered intravesically in adult participants with recurrent non-muscle invasive bladder cancer (NMIBC) and to determine the recommended Phase 2 dose (RP2D).

연구 개요

상태

아직 모집하지 않음

정황

개입 / 치료

상세 설명

This is a Phase 1, open-label, dose-escalation, multicenter study to investigate the safety, tolerability, immunogenicity, and pharmacokinetics (PK) of UGN-501, a chimeric oncolytic adenovirus, administered intravesically in participants with recurrent NMIBC.

Eligible participants will enter a 12-week Induction Period. Participants with Ta and/or T1 disease who do not have disease recurrence, and participants with carcinoma in situ (CIS) who have a complete response (CR) at Week 12, will enter the Maintenance Period. Disease assessments will be performed every 3 months through Month 15, or until disease recurrence, disease progression, or death, whichever occurs first.

The maximum duration of participation is approximately 15 months.

This master protocol may include multiple study intervention arms designed to independently evaluate UGN-501. Any additional study intervention arms or dose expansions will be added by protocol amendment.

연구 유형

중재적

등록 (추정된)

30

단계

  • 1단계

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 연락처

연구 장소

  • 미국
    • Arizona
      • Queen Creek, Arizona, 미국, 85140
        • East Valley Urology Center of Arizona
        • 수석 연구원:
          • Harpreet Wadhwa, MD
        • 연락하다:
    • California
      • Bakersfield, California, 미국, 93301
        • Michael G Oefelein Clinical Trials
        • 수석 연구원:
          • Michael Oefelein, MD
        • 연락하다:
      • Murrieta, California, 미국, 92563
        • Urology Center of Southern California
        • 수석 연구원:
          • Madhumitha Reddy, DO
        • 연락하다:
    • Massachusetts
      • Boston, Massachusetts, 미국, 02115
        • Brigham and Women's Hospital
        • 연락하다:
        • 수석 연구원:
          • Matthew Mossanen, MD, PhD
    • Nebraska
      • Omaha, Nebraska, 미국, 68198
        • University of Nebraska Medical Center
        • 수석 연구원:
          • Jared Schober, MD
        • 연락하다:
    • New York
      • New York, New York, 미국, 10029
        • Ichan School of Medicine at Mount Sinai
        • 수석 연구원:
          • John Sfakianos, MD
        • 연락하다:
      • Syracuse, New York, 미국, 13210
        • SUNY Upstate Medical University
        • 수석 연구원:
          • Joseph Jacob, MD
        • 연락하다:
    • Pennsylvania
      • Philadelphia, Pennsylvania, 미국, 19104
        • University of Pennsylvania-Perelman Center for Advanced Medicine
        • 수석 연구원:
          • Trinity Bivalacqua, MD, PhD
        • 연락하다:
    • South Carolina
      • Myrtle Beach, South Carolina, 미국, 29572
        • START Carolinas
        • 수석 연구원:
          • Abhishek Srivastava, MD
        • 연락하다:
    • Texas
      • Arlington, Texas, 미국, 76017
        • UPNT Research Institute
        • 연락하다:
        • 수석 연구원:
          • Patrick Collini, MD
      • Austin, Texas, 미국, 78759

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

  • 성인
  • 고령자

건강한 자원 봉사자를 받아들입니다

아니

설명

Inclusion Criteria:

  1. Participant must be 18 years of age or older at the time of signing informed consent.
  2. Has confirmed recurrent non-muscle invasive bladder cancer (NMIBC) with high-grade Ta and/or T1 disease and/or carcinoma in situ (CIS), or recurrent low-grade Ta and/or T1 disease.

  3. Participants with high-grade Ta and/or T1 disease and/or CIS must meet one of the following criteria:

    • Has BCG-unresponsive disease, defined as:
    • persistent or recurrent CIS alone or with recurrent Ta/T1 disease within 12 months of completion of adequate BCG therapy; or
    • recurrent high-grade Ta/T1 disease within 6 months of completion of adequate BCG therapy; or
    • high-grade T1 disease at the first evaluation following a BCG induction course.

    Adequate BCG therapy is defined as at least 5 of 6 doses of an initial induction course plus either at least 2 of 3 doses of maintenance therapy or at least 2 of 6 doses of a second induction course. Participants with BCG-unresponsive disease also must be unwilling or unfit to undergo radical cystectomy.

    • Is BCG-exposed, defined as high-grade persistent or recurrent NMIBC within 24 months of the last dose of BCG but not meeting the definition of BCG-unresponsive disease, and received at least 5 of 6 doses of an initial induction course of BCG.
    • Is BCG intolerant, defined as the inability to tolerate at least 1 full induction course of BCG.
    • Has a high-grade Ta tumor ≤3 cm and failed at least 1 previous course of therapy, such as TURBT plus an adjuvant induction course of intravesical chemotherapy.

  4. Participants with low-grade disease must meet one of the following criteria:

    • Ta tumors recurring within 1 year.
    • Ta solitary tumor >3 cm.
    • Ta multifocal tumors.
    • T1 tumors.
  5. All visible papillary tumors must be resected and obvious areas of CIS fulgurated during Screening or within 6 weeks before Screening. Participants with T1 disease should have a re-staging TURBT during Screening or within 6 weeks before Screening. Enhanced cystoscopy, such as blue light cystoscopy or other locally accepted modalities, is permitted, but the same modality must be used for all subsequent disease assessments.
  6. Has Eastern Cooperative Oncology Group performance status score ≤2.
  7. Has no concomitant upper tract urothelial carcinoma (UTUC) or urothelial carcinoma within the prostatic stroma. Freedom from upper tract disease, if clinically indicated, must be demonstrated by no evidence of upper tract tumor by either IV pyelogram, retrograde pyelogram, CT urogram with or without contrast, MRI urogram with or without contrast, or ureteroscopy with ureteral washing for cytology, performed within 6 months of enrollment. Participants with urothelial carcinoma involving the prostatic urethra, where carcinoma is confined to the ducts and/or epithelium, may be included after a restaging TURBT is performed to rule out more extensive disease involving the prostatic stroma.
  8. Participants with prostate cancer may be eligible if, after surgery or radiation, they do not meet criteria for biochemical recurrence, or if they are on active surveillance at very low, low, or favorable risk for progression, defined as Gleason Grade Group 1 or 2, Gleason score ≤7, prostate-specific antigen <20 ng/dL, and cT1-cT2b, at the discretion of the investigator.

  9. Has adequate organ and bone marrow function within 14 days of treatment initiation, as determined by routine laboratory tests:

    • Leukocytes ≥3000/μL.
    • Absolute neutrophil count ≥1500/μL.
    • Platelets ≥100,000/μL.
    • Hemoglobin ≥9.0 g/dL.
    • Total bilirubin ≤1.5 × upper limit of normal (ULN).
    • Aspartate aminotransferase (AST) ≤2.5 × UL
    • Alanine aminotrasferase (ALT) ≤2.5 × ULN.
    • Alkaline phosphatase ≤2.5 × ULN.
    • Estimated creatinine clearance ≥30 mL/min using the Cockcroft-Gault equation.
  10. Has a life expectancy >12 months.
  11. Participants and participant partners must agree to follow contraception and barrier method requirements consistent with local regulations and the protocol during the study intervention period and for at least 12 weeks after the last study intervention instillation.
  12. Has signed informed consent and is willing and able to comply with the requirements and restrictions listed in the informed consent form and protocol.

Exclusion Criteria:

  1. Current or previous evidence of muscle invasive, locally advanced nonresectable, or metastatic urothelial carcinoma, including T2, T3, T4, and/or stage IV disease.
  2. Current systemic therapy for bladder cancer.
  3. Prior treatment with any human adenovirus-based therapy, such as nadofaragene firadenovec-vncg or cretostimogene grenadenorepvec.
  4. Intravesical therapy within 4 weeks before starting study intervention, including but not limited to BCG, chemotherapy, and nogapendekin alfa inbakicept.
  5. Participation in a study of an investigational agent with receipt of study therapy, or receipt of an investigational device, within 4 weeks before the first dose of study intervention.
  6. Receipt of immune modulator therapy within 5 half-lives of starting study intervention, including but not limited to pembrolizumab, BCG, and nogapendekin alfa inbakicept.
  7. Receipt of a vaccine or anti-viral agent within 2 weeks before starting study intervention.
  8. Active infection requiring systemic therapy, including urinary tract infection. Participants may enter the study once the infection is satisfactorily treated.
  9. Immunocompromised state, including but not limited to HIV infection or any condition that required systemic immunosuppressive treatment in the past 2 years, such as active systemic autoimmune disease or solid organ or stem cell transplant. Short courses (≤14 days) of steroids for medical reasons without anticancer intent, such as atopic dermatitis, psoriasis, infection, or allergic reaction, are permitted if the last dose was at least 4 weeks before the first dose of study intervention.
  10. Any medical, psychological, familial, sociological, or geographical condition that, in the opinion of the investigator, would preclude participation in the study.
  11. History of malignancy of another organ system within the past 5 years, except previously treated UTUC, basal cell carcinoma or squamous cell carcinoma of the skin, and/or prostate cancer meeting protocol-specified criteria.
  12. Cannot tolerate intravesical dosing or intravesical surgical manipulation.
  13. Known allergy or hypersensitivity to any of the study interventions or any study intervention excipients.

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: 무작위화되지 않음
  • 중재 모델: 순차적 할당
  • 마스킹: 없음(오픈 라벨)

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: UGN-501 Dose Escalation (Part 1)
Dose escalation of UGN-501 in participants with recurrent NMIBC with high grade (HG) Ta and/or T1 disease and/or CIS or recurrent low grade (LG) Ta and/or T1 disease.
생물학적: UGN-501
UGN-501 is administered by intravesical instillation into the bladder. Participants receive 6 once-weekly instillations during the Induction Period. Participants eligible for maintenance receive 3 once-weekly instillations quarterly from Month 3 through Month 12.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Incidence of dose-limiting toxicities (DLTs) and treatment-emergent adverse events (TEAEs)
기간: Up to 15 Months
The number of participants with each type of event will be summarized.
Up to 15 Months
Concentration of UGN-501 in blood and urine
기간: Up to 12 Weeks
Data will be summarized using descriptive statistics.
Up to 12 Weeks
Complete response rate (CRR)
기간: 3 Months
CRR is defined as the proportion of CIS participants who achieved CR at the Week 12 (3-month) Visit.
3 Months
Recurrence-free survival (RFS) rate
기간: 6 Months
RFS rate is defined as the proportion of participants with Ta/T1 disease who are recurrence-free at the 6-month Visit.
6 Months

2차 결과 측정

결과 측정
측정값 설명
기간
Presence of anti-drug antibodies (ADA) in serum
기간: Up to 12 Weeks
The number of participants with ADA will be summarized.
Up to 12 Weeks
UGN-501 maximum concentration (Cmax) following single and repeat dose administration
기간: Up to 12 Weeks
Data will be summarized using descriptive statistics
Up to 12 Weeks
UGN-501 area under the concentration-time curve (AUC) following single and repeat dose administration
기간: Up to 12 Weeks
Data will be summarized using descriptive statistics.
Up to 12 Weeks
UGN-501 terminal half-life (t1/2) following single and repeat dose administration
기간: Up to 12 Weeks
Data will be summarized using descriptive statistics.
Up to 12 Weeks
UGN-501 time to maximum concentration (tmax) following single and repeat dose administration
기간: Up to 12 Weeks
Data will be summarized using descriptive statistics.
Up to 12 Weeks
UGN-501 concentration at the end of a dosing interval (Ctau) following single and repeat dose administration
기간: Up to 12 Weeks
Data will be summarized using descriptive statistics.
Up to 12 Weeks
Evaluation of viral shedding in urine following singe and repeat dose administration.
기간: Up to 12 Weeks
Data will be summarized using descriptive statistics.
Up to 12 Weeks

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

UroGen Pharma, Inc., a subsidiary of UroGen Pharma Ltd.

수사관

  • 연구 책임자: Sebastian Mirkin, MD, UroGen Pharma

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 30일

기본 완료 (추정된)

2029년 8월 2일

연구 완료 (추정된)

2029년 8월 2일

연구 등록 날짜

최초 제출

2026년 7월 21일

QC 기준을 충족하는 최초 제출

2026년 7월 21일

처음 게시됨 (실제)

2026년 7월 24일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 7월 24일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 7월 21일

마지막으로 확인됨

2026년 7월 1일

추가 정보

이 연구와 관련된 용어

키워드

추가 관련 MeSH 약관

기타 연구 ID 번호

  • UGN-501-101

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

예

미국 FDA 규제 기기 제품 연구

아니

미국에서 제조되어 미국에서 수출되는 제품

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

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