Cretostimogene for BCG‑unresponsive high‑grade non‑muscle‑invasive bladder cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is an open‑label, single‑arm Phase 2 study giving intravesical cretostimogene together with n‑dodecyl‑β‑D‑maltoside to patients with BCG‑unresponsive high‑risk non‑muscle‑invasive bladder cancer, specifically carcinoma in situ with or without concomitant high‑grade Ta/T1 disease. All visible Ta/T1 tumors are resected and CIS is resected or fulgurated as feasible before treatment. Patients are followed with scheduled cystoscopies, urine cytology, imaging and biopsies as needed to monitor tumor response and safety. The goal is to measure tumor clearance and durability of response after the single treatment regimen.

Why it matters

Who can join: the full rules

Inclusion Criteria:

In order to be eligible for participation in this trial, the patient must:

1. 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.
2. Have Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.
3. Have all Ta and/or T1 disease resected and all CIS resected or fulgurated, as feasible, prior to study treatment.
4. Demonstrate adequate organ function.
5. 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 Patients who withdraw consent for these procedures will be withdrawn from the trial.
6. Ineligible to receive radical cystectomy or refusal of radical cystectomy according to Investigator assessment.

Exclusion Criteria:

1. Has current or past history of muscle invasive (T2 or higher stage) or locally advanced (T3/T4, any N) or metastatic bladder cancer.
2. 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.
3. Has received systemic anti-cancer therapy, including investigational agents.
4. 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.
5. 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.
6. Cannot tolerate study-related biopsies, IVE administration, or 1-hour bladder hold of Cretostimogene.

Where it's running

• Peking University First Hospital (First Clinical Medical School of Peking University)
  Beijing, Beijing Municipality, China Recruiting
• Chongqing University Cancer Hospital
  Chongqing, Chongqing Municipality, China Recruiting
• Fujian Cancer Hospital
  Fuzhou, Fujian, China Recruiting
• Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
  Wuhan, Hubei, China Recruiting
• Hunan Cancer Hospital
  Changsha, Hunan, China Recruiting
• The Affiliated Drum Tower Hospital of Nanjing University Medical School
  Nanjing, Jiangsu, China Recruiting

Study contacts

• Principal investigator: Dinɡwei Ye, M.D. — Fudan University
• Study coordinator: Program Director
• Email: clinicaltrials@lepubiopharma.com
• Phone: 86-21-61637960

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• NMIBC sample collection to test cancer monitoring biomarkers

  This study tests a blood, urine, and tumor tissue collection approach in people with high-risk non-muscle invasive bladder cancer to see if a molecular test can detect residual disease and monitor recurrence.

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• Sequential Gemcitabine Plus Docetaxel vs Gemcitabine Plus Mitomycin C for BCG-Unresponsive NMIBC

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• Is ongoing systemic immunotherapy needed after achieving tumor-free status in very-high-risk NMIBC?

  This study tests whether patients who have become tumor-free after a systemic immunotherapy-based bladder-sparing treatment can safely stop therapy and instead be watched closely.

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• Testing PF-08052667 for high-risk non-muscle invasive bladder cancer

  This study will test whether the new medicine PF-08052667, alone or with BCG and/or sasanlimab, helps adults with high-risk non-muscle invasive bladder cancer that has come back or not responded to standard treatment.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.