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

NCT07283835 | Recruiting Phase 2 FDA Drug

• 1 other identifier: CG0070-II-CIS-01
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 14

Brief 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

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

Keywords

high-grade Ta papillary disease; high-grade T1 papillary disease; carcinoma in situ; Bacillus-Calmette-Guerin unresponsive

Outcome Measures

Primary Outcomes (1)

• Complete response rate at any time in BCG-unresponsive high-risk NMIBC with or without Ta/T1 papillary tumors including CIS

  36 months

Secondary Outcomes (6)

• Duration of response (DOR)

  36 months

• Assess high-grade reoccurrence free survival (RFS)

  36 months

• Assess progression free survival (PFS)

  36 months

• Complete response rate at 12, 24, and 36 months

  Assessed at 12, 24, and 36 months

• Overall survival rate at 36 months

  36 months

Study Arms (1)

Cretostimogene

EXPERIMENTAL

Patients with CIS with or without HG Ta/T1 papillary disease. Cretostimogene will be administered intravesically following a series of bladder washes with 5% DDM and normal saline. Cretostimogene will be administered weekly for specific schedule per protocol.

Biological: Cretostimogene Grenadenorepvec; Other: n-dodecyl-B-D-maltoside

Interventions

n-dodecyl-B-D-maltoside OTHER

Transduction-enhancing agent

Also known as: DDM

Cretostimogene

Cretostimogene Grenadenorepvec BIOLOGICAL

Engineered Oncolytic Adenovirus

Also known as: CG0070

Cretostimogene

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• In order to be eligible for participation in this trial, the patient must:
• Be ≥18 years of age on day of signing informed consent.
• \- Patients must have pathologically confirmed BCG-unresponsive non-muscle-invasive bladder cancer (NMIBC) with carcinoma in situ (CIS), with or without concomitant Ta/T1 papillary disease.
• Have Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.
• Have all Ta and/or T1 disease resected and all CIS resected or fulgurated, as feasible, prior to study treatment.
• Demonstrate adequate organ function.
• Patients must be willing to comply with study mandated cystoscopies, urine cytology, urograms, biopsies, and other procedures (including TURBT or other resection for all Ta/T1 disease) for the duration of the study. Patients who withdraw consent for these procedures will be withdrawn from the trial.
• Ineligible to receive radical cystectomy or refusal of radical cystectomy according to Investigator assessment.

You may not qualify if:

• Has current or past history of muscle invasive (T2 or higher stage) or locally advanced (T3/T4, any N) or metastatic bladder cancer.
• History of urothelial carcinoma in the upper genitourinary tract (kidney, renal collecting system, ureter) or in the prostatic urethra, including urethral CIS, within 24 months prior to enrollment.
• Has received systemic anti-cancer therapy, including investigational agents.
• Has had prior systemic treatment (with the exception of checkpoint inhibitor therapy), radiation therapy, or surgery for bladder cancer other than TURBT or bladder biopsies.
• Has any of the following within the 6 months prior to starting study treatment: myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass graft, cerebrovascular accident, pulmonary embolus, uncontrolled hypertension, or uncontrolled congestive heart failure.
• Cannot tolerate study-related biopsies, IVE administration, or 1-hour bladder hold of Cretostimogene.

Sponsors & Collaborators

• Lepu Biopharma Co., Ltd.: lead

Study Sites (14)

Peking University First Hospital (First Clinical Medical School of Peking University)

Beijing, Beijing Municipality, 100034, China

RECRUITING

Chongqing University Cancer Hospital

Chongqing, Chongqing Municipality, 400030, China

RECRUITING

Fujian Cancer Hospital

Fuzhou, Fujian, 350014, China

RECRUITING

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Wuhan, Hubei, 430022, China

RECRUITING

Hunan Cancer Hospital

Changsha, Hunan, 410013, China

RECRUITING

The Affiliated Drum Tower Hospital of Nanjing University Medical School

Nanjing, Jiangsu, 210008, China

RECRUITING

The First Hospital of China Medical University

Shenyang, Liaoning, 110001, China

RECRUITING

Qilu Hospital of Shandong University

Jinan, Shandong, 250012, China

RECRUITING

Ruijin Hospital, Shanghai Jiao Tong University School of Medicine

Shanghai, Shanghai Municipality, 200025, China

RECRUITING

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, 200032, China

RECRUITING

West China Hospital, Sichuan University

Chengdu, Sichuan, 610041, China

RECRUITING

The Second Hospital of Tianjin Medical University

Tianjin, Tianjin Municipality, 300211, China

RECRUITING

The First Affiliated Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310003, China

RECRUITING

The First Affiliated Hospital of Wenzhou Medical University

Wenzhou, Zhejiang, 325000, China

RECRUITING

MeSH Terms

Conditions

Non-Muscle Invasive Bladder Neoplasms; Carcinoma in Situ

Interventions

dodecyl maltoside

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Urinary Bladder Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases

Study Officials

• Dinɡwei Ye, M.D.

  Fudan University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Program Director

CONTACT

86-21-61637960; clinicaltrials@lepubiopharma.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 6, 2025
• First Posted: December 16, 2025
• Study Start: December 4, 2025
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2028
• Last Updated: April 23, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (14)