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)

قيد التجنيديقبل مشاركين الآن، وفقاً لسجل السجل.

التواصل مع هذه الدراسة

باختصار

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.

المرحلة 2مطلوب 325 مشاركاً80 موقعاًدولتان

الفئات

علم الأورام52%الكلى والمسالك البولية39%التوليد وأمراض النساء9%

مسجَّلة في سجل واحد

ClinicalTrials.govNCT06567743فتح هذا السجل في ClinicalTrials.govتمت المزامنة قبل 3 أسابيع

يمكن أن تُسجَّل دراسة واحدة في عدة سجلات. نعرضها مرة واحدة ونربط بكل سجل نحتفظ به.

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هل أنت مهتم بهذه الدراسة؟

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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.

ملخص

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.

الحالات

High-Risk Non-Muscle-Invasive Bladder Cancer

الأهلية

الأهلية
الجنس	الجميع
الأعمار	18 Years – لا حد أقصى
المتطوعون الأصحّاء	لا

الأهلية كما كُتبت في السجل

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

الأهلية في عبارات بسيطة

لم تُقسَّم معايير هذا السجل إلى عبارات منفصلة بعد. نص السجل أعلاه كامل وهو النسخة المُعتمَدة.

تصميم الدراسة

تصميم الدراسة
نوع الدراسة	تدخّلية
المرحلة	المرحلة 2
التخصيص	معشّاة
نموذج التدخّل	PARALLEL
الغرض الأساسي	TREATMENT
التعمية	NONE (0)
التجنيد	مطلوب 325 مشاركاً

الجهة الراعية والمتعاونون

CG Oncology, Inc. الجهة الراعية

الأذرع والتدخلات

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

التدخلات

دواء Cretostimogene Grenadenorepvec
Respective Cohort

مقاييس النتائج

مقياس النتيجة الأولي
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
الإطار الزمني At 11 and 24 weeks
مقياس النتيجة الأولي
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.
الإطار الزمني 48 months
مقياس النتيجة الأولي
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.
الإطار الزمني At 11 and 24 weeks
مقياس النتيجة الأولي
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.
الإطار الزمني 48 months
مقياس النتيجة الأولي
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.
الإطار الزمني 48 months
مقياس النتيجة الأولي
Cohort CX (Arms 1 and 2): Safety
Determine the safety of concurrent cretostimogene and gemcitabine and sequential cretostimogene and gemcitabine.
الإطار الزمني 48 months
مقياس النتيجة الثانوي
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.
الإطار الزمني At 11 and 24 weeks
مقياس النتيجة الثانوي
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
الإطار الزمني At 12 months
مقياس النتيجة الثانوي
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
الإطار الزمني 48 months
مقياس النتيجة الثانوي
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
الإطار الزمني At 12 months
مقياس النتيجة الثانوي
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.
الإطار الزمني At 11 and 24 weeks

التواريخ

التواريخ
تاريخ البدء	16 سبتمبر 2024 (فعلي)
الإتمام الأولي	31 مارس 2027 (تقديري)
الإتمام	30 ديسمبر 2027 (تقديري)
أول نشر	23 أغسطس 2024 (فعلي)
آخر تحديث	3 سبتمبر 2026
النتائج منشورة	غير مذكور في سجل السجل
آخر تأكيد للحالة	سبتمبر 2026

فعلي يعني أن الحدث وقع. تقديري يعني أن الجهة الراعية تتوقعه. للكلمتين معنيان مختلفان.

المواقع

76 موقعاً قيد التجنيد

Canada

Canada
المنشأة	المدينة	الولاية أو المنطقة	الحالة
Centre of Applied Urology Research Nova Scotia Health Authority	Halifax	Nova Scotia	قيد التجنيد

United States

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

يُدرَج 30 موقعاً إضافياً في سجل السجل.

مستندات الدراسة

لا تُرتبط أي مستندات في سجل السجل هذا.

التغيّرات عبر الزمن

3 سبتمبر 2026
أُضيف موقع
15 sites added (80 total)
6580

السجل: ClinicalTrials.gov · NCT########

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