Phase 2 Study to Evaluate Safety and Efficacy of Cretostimogene Grenadenorepvec in NMIBC

Phase 2

Not yet recruiting

• Conditions: High-Risk Non-Muscle-Invasive Bladder Cancer

• Registration Number: NCT06567743
• Lead Sponsor: CG Oncology, Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-8-14
• Last Update Posted: 2 September 2024

Recruitment & Eligibility

• Status: Not yet recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Inclusion Criteria:<br><br> - To be eligible for participation in this trial, participants must meet all the<br> following entry criteria. The participant must:<br><br> 1. Be =18 years of age (or legal age of majority in the jurisdiction) on day of<br> signing informed consent<br><br> 2. Have Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.<br><br> 3. Have pathologically confirmed (World Health Organization [WHO] grading system<br> employed for tumor grading) (Compérat 2019) BCG-naïve, CIS-containing (i.e.,<br> CIS with or without concomitant HG Ta/T1) high-risk NMIBC within 90 days of<br> randomization.<br><br> Participants with BCG-naïve NMIBC should have either:<br><br> No prior treatment with BCG OR No treatment with BCG within the past 24 months<br> prior to current pathological diagnosis OR A maximum of 1 or 2 doses of BCG<br> within the past 24 months prior to current pathological diagnosis.<br><br> NOTE:<br><br> Tumor risk stratification is determined by 2024 American Urological Association<br> (AUA) guidelines (Holzbeierlein 2024).<br><br> All pathology specimens must be predominantly urothelial (transitional cell)<br> and have less than 50% histologic subtype/variant histology (e.g.,<br> micropapillary, nested, plasmacytoid, neuroendocrine, sarcomatoid, squamous, or<br> glandular differentiation).<br><br> Any prior combination BCG treatment will be considered as additional BCG<br> therapy.<br><br> 4. Have all Ta and/or T1 disease resected, and all CIS resected or fulgurated, as<br> feasible within 90 days prior to randomization.<br><br> NOTE:<br><br> Participants with T1 NMIBC at screening should have a repeat biopsy evaluation<br> of the prior resection site at least 2 weeks prior to randomization to<br> adequately rule out muscle invasion or T2 disease.<br><br> If there is a concern for incomplete resection/regrowth, a repeat cystoscopy is<br> recommended to ensure absence of disease prior to randomization.<br><br> Starting at screening and throughout the treatment phase, study treatment will<br> be administered at least 14 days following the most recent transurethral<br> resection (TUR) or biopsy. In addition, during the treatment phase,<br> cretostimogene treatment will begin no later than 28 days after the most recent<br> TUR or biopsy. CG Oncology approval is required for cretostimogene treatment<br> cycle to begin less than 14 days after the most recent TUR or biopsy.<br><br> 5. Refuse radical cystectomy.<br><br> 6. Demonstrate adequate organ function<br><br>Exclusion Criteria:<br><br>The participant must be excluded from participating in the trial if the participant:<br><br> 1. Has a current or past history of muscle invasive (T2 or higher stage), locally<br> advanced (T3/T4, any N) or metastatic bladder cancer.<br><br> 2. Any HG, non-muscle-invasive urothelial carcinoma (T1, HG Ta, or CIS) in the upper<br> genitourinary tract or prostatic urethra (including CIS of the urethra) within 24<br> months prior to randomization or treatment allocation OR any history of T2 or higher<br> stage urothelial carcinoma in the upper genitourinary tract (kidneys, renal<br> collecting systems, ureters).<br><br> 3. Has had any prior systemic treatment (except for checkpoint inhibitor therapy),<br> radiation therapy, or surgery (except for TURBT/biopsy/fulguration) for bladder<br> cancer. Previous intravesical therapies are allowed if they do not contravene any<br> other exclusion criteria.<br><br> 4. Has received intravesical therapy within 90 days prior to randomization or treatment<br> allocation except for cytotoxic agents (e.g., mitomycin C, gemcitabine, doxorubicin,<br> and epirubicin) when administered as a single instillation immediately following a<br> TURBT.

Exclusion Criteria

Not provided

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Complete response (CR) rate

Secondary Outcome Measures

Name	Time	Method
Compare cretostimogene instillation methods;Duration of response (DoR)