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Study of Cretostimogene Given in Patients With Non-Muscle Invasive Bladder Cancer ,Unresponsive to Bacillus-Calmette-Guerin

NCT07283835 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2026-04-23

No results posted yet for this study

Summary

This study aims to evaluate the efficacy and safety of Cretostimogene in patients with BCG-unresponsive high-risk non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS), with or without Ta/T1 papillary tumors.

Conditions

  • Non Muscle Invasive Bladder Cancer
  • High-grade Ta/ T1 Papillary Disease Bladder Cancer

Interventions

OTHER

n-dodecyl-B-D-maltoside

Transduction-enhancing agent

BIOLOGICAL

Cretostimogene Grenadenorepvec

Engineered Oncolytic Adenovirus

Sponsors & Collaborators

  • Lepu Biopharma Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Dinɡwei Ye, M.D. · Fudan University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-12-04
Primary Completion
2027-12-31
Completion
2028-12-31
FDA Drug
Yes

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07283835 on ClinicalTrials.gov