NCT06567743ClinicalTrials.gov

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

A Phase 2, Multi-Arm, Multi-Cohort, Open-Label Study to Evaluate the Safety and Efficacy of Cretostimogene Grenadenorepvec in Participants With High-Risk Non-Muscle-Invasive Bladder Cancer (NMIBC)

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En resumen

This is a Phase 2, Multi-Arm, Multi-Cohort, Open-Label Study to Evaluate the Safety and Efficacy of Cretostimogene Grenadenorepvec in Participants with High-Risk Non-Muscle-Invasive Bladder Cancer.

Fase 2325 participantes buscados80 centros2 países

Categorías

Oncología52%Nefrología y urología39%Obstetricia y ginecología9%

Registrado en 1 registro

ClinicalTrials.govNCT06567743Abrir este registro en ClinicalTrials.govSincronizado hace 3 semanas

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La información del ensayo se muestra tal como la publicó el registro, en su idioma original.

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How this study is set up

The points below are drawn from the public registry record for this study. Each one cites the field or sentence it came from. A dash (—) means the record does not state something — not that it is missing or wrong. Many well-run studies, especially small ones, leave some of these blank.

Present: Registered before enrolment beganFirst posted 2024-08-23; recorded start 2024-09-16
Present: Has a defined primary outcomeA primary outcome measure is listed in the record
Present: The primary outcome states a time frameThe primary outcome measure records a time frame
Present: Participants are randomly assignedAllocation is recorded as randomised
Present: Has a comparison groupThe record lists a placebo or comparator arm, or more than one study arm
Not stated: Open label (no blinding)Masking is recorded as none (open label)
Not stated: An ethics committee is not stated in the registry recordThis registry's ingested record has no ethics-committee field
Not stated: Regulatory oversight (such as an IND or IDE) is not stated in the registry recordThis registry's ingested record has no regulatory-authorisation field
Not stated: A data monitoring committee is not stated in the registry recordThis registry's ingested record has no data-monitoring-committee fieldA data monitoring committee is not required for many smaller studies, and its absence here is not unusual.
Present: No cost to participants is mentioned in the recordChecked the summary, description and eligibility text; no cost-to-participant phrase found
Present: Sponsor has 3 other studies in this databaseCounted from the lead sponsor named in the record (CG Oncology, Inc.)
Not stated: No posted results from this sponsor are in this database yetBased on the sponsor’s studies in this database

The record lists 1 condition.
Lead sponsor type recorded as: industry.
Intervention regulatory context: investigational, within a phased regulatory pathway.

These are facts from the public registry record, not a judgement about the study. Discuss any trial with your own doctor before taking part.

What these facts mean, and what to ask · ruleset v1

Trial stature

Three independent measures of this study, described from its registry record — not a recommendation about it. A rigorous study by investigators nobody has heard of is better evidence than a weak study led by a famous one. How these are scored.

Methodological rigourMODERATE

A moderately rigorous design for a phase 2 study, judged from its ClinicalTrials.gov record.

How this score is built

Randomised allocation20/20
Participants are randomly allocated between arms
Blinding0/20
Open-label
Control arm0/15
No comparator arm stated in the record
Primary-outcome specificity10/10
Named primary outcome with a defined time frame
Endpoint type3/10
Surrogate or intermediate endpoint (conservative default)
Multi-centre8/8
Multi-centre: 65 sites
Data monitoring committee7/7
A data monitoring committee is in place
Prospective registration5/5
Registered before the study start date
Protocol / SAP posted0/5
No protocol or SAP posted to the registry

ScaleMEDIUM

A medium-sized study, international in scope: 325 participants (target), run at 80 sites, across 2 countries.

How this score is built

Enrolment24/40
325 participants (target)
Site count21/25
65 sites
Country count0/15
Single country
Planned duration8/10
Planned over about 40 months
Sponsor scale2/10
CG Oncology, Inc. has led 4 trials in our corpus

Investigator standingUNKNOWN

We have no verifiable track record for the investigator named on this trial. That is common for early-career investigators and for records held outside ClinicalTrials.gov — it is not a negative signal.

How this score is built

Investigator standing0/100
No investigator recorded in the registry for this trial

These describe the registry record only, and today we hold ClinicalTrials.gov data. Absent fields lower a score, and absence often reflects registration practice rather than study quality. A high-stature trial is not necessarily safer or a better choice for you — enrolling in a large definitive trial can mean a higher chance of receiving placebo, while a small early-phase study may be the only route to a new therapy.

Resumen

This is a Phase 2, Multi-Arm, Multi-Cohort, Open-Label Study to Evaluate the Safety and Efficacy of Cretostimogene Grenadenorepvec in Participants with High-Risk Non-Muscle-Invasive Bladder Cancer.

In Cohort A, up to 125 participants will be enrolled with pathologically confirmed, high-risk high-grade non-muscle invasive bladder cancer (NMIBC) NMIBC (i.e., CIS with or without concomitant Ta or T1 disease OR HG Ta/T1 disease without CIS) which is naïve to Bacillus Calmette-Guerin (BCG) treatment. Participants with CIS with or without concomitant Ta/T1 NMIBC at baseline will be randomized 1:1 to receive cretostimogene via the current (Arm 1) or an alternative instillation procedure (Arm 2). Participants with papillary-only high-risk NMIBC (i.e., HG Ta/T1 without CIS) at baseline (Arm 3) will receive cretostimogene via the alternative instillation procedure. In Cohort B, up to 150 participants will be enrolled with pathologically confirmed, high-risk high-grade NMIBC (i.e., CIS with or without concomitant Ta or T1 disease OR HG Ta/T1 disease without CIS) which has previously been exposed to BCG treatment. Participants with CIS-containing pathology at baseline will be recruited into Arm 1 and participants with papillary-only pathology at baseline will be recruited into Arm 2. Both Cohort B Arms 1 and 2 will receive cretostimogene via the alternative instillation procedure. In Cohort CX, up to 50 participants will be enrolled with pathologically confirmed, high-risk high-grade NMIBC (i.e., CIS with or without concomitant Ta or T1 disease OR HG Ta/T1 disease without CIS) which has previously been exposed to or is unresponsive to BCG treatment. Participants will be randomized 1:1 to receive cretostimogene and gemcitabine either concurrently or sequentially. In all cohorts, study treatment will be administered as a weekly induction course for the first 6 weeks with a reinduction course administered to patients who have CIS and/or high-grade Ta disease at the 3-month evaluation. Following induction, if no high-grade disease is detected, maintenance treatment will begin. This consists of a cycle of three weekly treatments every three months during the first year, and every six months during the second year, with an optional extension to the third year following the same six-month schedule. Disease status will be assessed using urine cytology, complete bladder visualization (e.g., cystoscopy), upper tract assessment and directed resection/biopsy (if indicated) every 3 months for the first 2 years and then every 6 months for a further 2 years or until disease recurrence.

Afecciones

High-Risk Non-Muscle-Invasive Bladder Cancer

Elegibilidad

Elegibilidad
Sexo	Todos
Edades	18 Years – Sin máximo
Voluntarios sanos	No

Elegibilidad tal como figura en el registro

Cohort A Key Inclusion Criteria: * Pathologically confirmed BCG-naïve high-risk high-grade NMIBC (i.e., CIS with or without Ta/T1 disease or high-grade Ta/T1 papillary-only disease without CIS) within 90 days of treatment allocation. * All visible disease must be resected, and all CIS resected or fulgurated, as feasible within 90 days prior to treatment allocation. * Acceptable baseline organ function. Cohort B Key Inclusion Criteria: * Pathologically confirmed BCG-exposed high-risk high-grade NMIBC (i.e., CIS with or without Ta/T1 disease or high-grade Ta/T1 papillary-only disease without CIS) within 90 days of treatment allocation. * All visible disease must be resected, and all CIS resected or fulgurated, as feasible within 90 days prior to treatment allocation. * Acceptable baseline organ function. Cohort CX Inclusion Criteria * Pathologically confirmed high-risk high-grade BCG-unresponsive or BCG-exposed NMIBC (i.e., CIS with or without Ta/T1 disease or high-grade Ta/T1 papillary-only disease without CIS) within 90 days of treatment allocation. * All visible disease must be resected, and all CIS resected or fulgurated, as feasible within 90 days prior to treatment allocation. * Acceptable baseline organ function. Key Exclusion Criteria (Both Cohorts): * Current or past history of muscle-invasive, locally advanced or metastatic bladder cancer. * High-grade urothelial carcinoma in the upper urinary tract or prostatic urethra within 24 months or T2 in upper tract within 48 months or any history of locally advanced/ nodal or metastatic disease in the upper urinary tract. * Significant immunodeficiency. * Pregnant or breastfeeding. * Cohort CX Only: serial intravesical gemcitabine within 24 months

Elegibilidad en frases sencillas

Los criterios de este registro aún no se han desglosado en frases separadas. El texto del registro anterior está completo y es la versión autorizada.

Diseño del estudio

Diseño del estudio
Tipo de estudio	De intervención
Fase	Fase 2
Asignación	Aleatorizado
Modelo de intervención	PARALLEL
Propósito principal	TREATMENT
Enmascaramiento	NONE (0)
Inscripción	325 participantes buscados

Patrocinador y colaboradores

CG Oncology, Inc. Patrocinador

Grupos e intervenciones

Experimental: Cohort A, Arm 1EXPERIMENTAL
Cretostimogene (1 x 1012 vp) will be administered intravesically via the current instillation method
Experimental: Cohort A, Arm 2EXPERIMENTAL
Cretostimogene (1 x 1012 vp) will be administered intravesically via an alternative instillation method.
Experimental: Cohort A, Arm 3EXPERIMENTAL
Cretostimogene (1 x 1012 vp) will be administered intravesically via an alternative instillation method.
Experimental: Cohort B, Arm 1EXPERIMENTAL
Cretostimogene (1 x 1012 vp) will be administered intravesically via an alternative instillation method.
Experimental: Cohort B, Arm 2EXPERIMENTAL
Cretostimogene (1 x 1012 vp) will be administered intravesically via an alternative instillation method.
Experimental: Cohort CX, Arm 1EXPERIMENTAL
At all treatment visits cretostimogene (1 x 1012 vp) will be administered intravesically via an alternative instillation method followed by gemcitabine instilled intravesically
Experimental: Cohort CX, Arm 2EXPERIMENTAL
Cretostimogene (1 x 1012 vp) will be administered intravesically via an alternative instillation method for two consecutive weeks, followed by gemcitabine administered intravesically in the third week on a cyclic 2:1 visit schedule basis

Intervenciones

Fármaco Cretostimogene Grenadenorepvec
Respective Cohort

Variables de resultado

Variable de resultado principal
Cohort A (Arm 1 and 2): Complete response rate
Determine the complete response rate at any time following treatment with cretostimogene in participants with BCG-naïve CIS with or without concomitant high-grade Ta or T1 disease at baseline
Plazo At 11 and 24 weeks
Variable de resultado principal
Cohort A (Arm 3): High- Grade Event-Free Survival
Determine the High-Grade Event-Free Survival following treatment with cretostimogene in participants with BCG-naïve HG Ta/T1 disease without concomitant CIS at baseline.
Plazo 48 months
Variable de resultado principal
Cohort B (Arm 1): Complete response rate
Determine the complete response rate at any time following treatment with cretostimogene in participants with BCG-exposed CIS with or without concomitant high-grade Ta or T1 disease at baseline.
Plazo At 11 and 24 weeks
Variable de resultado principal
Cohort B (Arm 2): High-Grade Event-Free Survival
Determine the High-Grade Event-Free Survival following treatment with cretostimogene in participants with BCG-exposed high-grade Ta/T1 papillary disease without CIS at baseline.
Plazo 48 months
Variable de resultado principal
Cohort CX (Arms 1 and 2): High-Grade Event-Free Survival
Determine the High-Grade Event-Free Survival following treatment with cretostimogene in participants with BCG-exposed or BCG-unresponsive high-grade NMIBC.
Plazo 48 months
Variable de resultado principal
Cohort CX (Arms 1 and 2): Safety
Determine the safety of concurrent cretostimogene and gemcitabine and sequential cretostimogene and gemcitabine.
Plazo 48 months
Variable de resultado secundaria
Cohort A (Arms 1 and 2): Evaluate cretostimogene instillation methods
Evaluate cretostimogene genome and GM-CSF levels, treatment efficacy, and safety by 2 different methods of cretostimogene instillation in participants with pathologically confirmed CIS-containing high-risk NMIBC who are naïve to BCG treatment.
Plazo At 11 and 24 weeks
Variable de resultado secundaria
Cohort A (Arm 3): High-Grade Event-Free Survival at 12 months
Determine the proportion of participants with BCG-naive papillary-only high-grade NMIBC at baseline who are free from high-grade events at 12 months
Plazo At 12 months
Variable de resultado secundaria
Cohort A (Arms 1 and 2) and Cohort B (Arm 1) Duration of response
Assess duration of response in participants with CIS with or without concomitant HG Ta/T1 disease at baseline
Plazo 48 months
Variable de resultado secundaria
Cohort B (Arm 2) High-Grade Event-Free Survival at 12 months
Determine the proportion of participants with BCG-exposed papillary-only high-grade NMIBC at baseline who are free from high-grade events at 12 months
Plazo At 12 months
Variable de resultado secundaria
Cohort CX (Arm 1 and 2) Complete response rate
Determine the complete response rate at any time following treatment with cretostimogene and gemcitabine in participants with BCG-exposed or BCG-unresponsive CIS with or without concomitant high-grade Ta or T1 disease at baseline.
Plazo At 11 and 24 weeks

Fechas

Fechas
Fecha de inicio	16 de septiembre de 2024 (real)
Finalización principal	31 de marzo de 2027 (estimada)
Finalización	30 de diciembre de 2027 (estimada)
Primera publicación	23 de agosto de 2024 (real)
Última actualización	3 de septiembre de 2026
Resultados publicados	No indicado en el registro
Estado verificado por última vez	septiembre de 2026

Real significa que el evento ocurrió. Estimada significa que el patrocinador lo prevé. Ambas cosas significan algo distinto.

Ubicaciones

76 centros están en reclutamiento

Canada

Canada
Centro	Ciudad	Estado o región	Estado
Centre of Applied Urology Research Nova Scotia Health Authority	Halifax	Nova Scotia	En reclutamiento

United States

United States
Centro	Ciudad	Estado o región	Estado
Potomac Urology	Alexandria	Virginia	En reclutamiento
Amarillo Urology Research	Amarillo	Texas	Completado
Anne Arundel Urology	Annapolis	Maryland	En reclutamiento
UPNT Research Institute, LLC	Arlington	Texas	En reclutamiento
Emory University	Atlanta	Georgia	En reclutamiento
Urology Austin, PLLC (Urology America)	Austin	Texas	En reclutamiento
Michael G Oefelein, MD Clinical Trials	Bakersfield	California	En reclutamiento
Midlantic Urology (Solaris)	Bala-Cynwyd	Pennsylvania	En reclutamiento
Brigham and Women's Hospital	Boston	Massachusetts	En reclutamiento
Urology of Indiana - Carmel	Carmel	Indiana	En reclutamiento
University of North Carolina	Chapel Hill	North Carolina	En reclutamiento
Charleston Area Medical Center	Charleston	South Carolina	En reclutamiento
Atrium Health/Levine Center	Charlotte	North Carolina	En reclutamiento
Associated Urological Specialists	Chicago Ridge	Illinois	En reclutamiento
The Urology Group (Solaris)	Cincinnati	Ohio	En reclutamiento
University of Cincinnati Cancer Center	Cincinnati	Ohio	En reclutamiento
Cleveland Clinic	Cleveland	Ohio	En reclutamiento
Urology Center of Iowa Research	Clive	Iowa	En reclutamiento
Ohio State University	Columbus	Ohio	En reclutamiento
UT Southwestern Medical Center	Dallas	Texas	En reclutamiento
Urology Clinics of North Texas, PLLC	Dallas	Texas	En reclutamiento
Central Ohio Urology Group (US Urology Partners)	Gahanna	Ohio	En reclutamiento
University of Florida	Gainesville	Florida	En reclutamiento
The Conrad Pearson Clinic (Urology America)	Germantown	Tennessee	En reclutamiento
Banner MD Anderson Cancer Center	Gilbert	Arizona	En reclutamiento
Uropartners	Glenview	Illinois	En reclutamiento
Urology of Indiana, LLC (US Urology Partners)	Greenwood	Indiana	En reclutamiento
Hackensack University Medical Center	Hackensack	New Jersey	En reclutamiento
Chesapeake Urology Research Associates	Hanover	Maryland	En reclutamiento
Penn State University Milton S. Hershey Medical Center	Hershey	Pennsylvania	En reclutamiento
Houston Methodist	Houston	Texas	En reclutamiento
City of Hope	Irvine	California	En reclutamiento
Mayo Clinic Florida	Jacksonville	Florida	En reclutamiento
First Urology, PSC	Jeffersonville	Indiana	En reclutamiento
Southern Urology (Urology America)	Lafayette	Louisiana	En reclutamiento
Colorado Urology	Lakewood	Colorado	En reclutamiento
Keystone Urology Specialists	Lancaster	Pennsylvania	En reclutamiento
Advanced Urology Institute (Solaris)	Largo	Florida	En reclutamiento
Accellacare	Lisle	Illinois	En reclutamiento
University of Arkansas for Medical Sciences	Little Rock	Arkansas	En reclutamiento
Arkansas Urology	Little Rock	Arkansas	En reclutamiento
Urology Associates, Lone Tree	Lone Tree	Colorado	En reclutamiento
Genesis Research (Greater Los Angeles)	Los Alamitos	California	En reclutamiento
Advanced Urology	Los Angeles	California	Retirado
Urologic Specialists of Northwest Indiana (Solaris)	Merrillville	Indiana	En reclutamiento
Urology Center of Southern California	Murrieta	California	En reclutamiento
Carolina Urologic Research Center, LLC	Myrtle Beach	South Carolina	En reclutamiento
Urology Associates, PC	Nashville	Tennessee	En reclutamiento
Ochsner Medical Center	New Orleans	Louisiana	En reclutamiento

En el registro figuran 30 centros más.

Documentos del estudio

No hay documentos enlazados en este registro.

Cambios a lo largo del tiempo

3 de septiembre de 2026
Centro añadido
15 sites added (80 total)
6580

Registro: ClinicalTrials.gov · NCT########

https://xmedica.io/trials/ctgov/NCT06567743