Cretostimogene Grenadenorepvec for Bladder Cancer

Recruiting at 100 trial locations

Overseen By Jalees Farhan, MD

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: CG Oncology, Inc.

Disqualifiers: High-risk NMIBC, Low-risk NMIBC, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 9

Duration: 13 months

367 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

The trial is studying a new treatment called cretostimogene grenadenorepvec (CG0070) for bladder cancer. It aims to determine if this treatment can prevent bladder cancer from returning after a surgery called TURBT, which removes tumors. Participants will either receive the treatment after surgery or undergo close monitoring to compare results. The trial seeks individuals with bladder cancer who have had their tumors removed and meet specific conditions, such as having had certain types of tumors recently. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants the opportunity to contribute to a potentially groundbreaking treatment.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that cretostimogene grenadenorepvec is generally safe. In earlier studies, 75.5% of patients experienced a complete response, and the treatment effects lasted a long time, indicating it is usually well-tolerated.

Cretostimogene grenadenorepvec is a cancer treatment that specifically targets and destroys cancer cells. It acts like a virus that infects only cancer cells, leaving healthy cells unharmed. This targeted approach helps minimize side effects.

Reports indicate that patients usually handle the treatment well, with no major safety concerns. It has also been tested in other conditions, further supporting its safety.

Overall, for those considering participation in a trial with cretostimogene grenadenorepvec, research suggests it is a safe option for patients with bladder cancer. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for bladder cancer?

Unlike the standard treatments for bladder cancer, such as surgery, chemotherapy, or immunotherapy, cretostimogene grenadenorepvec introduces a novel approach by using genetically modified viruses to target and destroy cancer cells. This innovative treatment utilizes an oncolytic virus, which specifically infects and kills cancer cells while sparing normal cells, potentially reducing the side effects associated with traditional therapies. Researchers are particularly excited about this treatment because it represents a cutting-edge advance in precision medicine, offering a targeted attack on cancer cells with the potential for improved effectiveness and safety in treating bladder cancer.

What evidence suggests that cretostimogene grenadenorepvec might be an effective treatment for bladder cancer?

Research has shown that cretostimogene grenadenorepvec holds promise for treating bladder cancer. In this trial, some participants will receive cretostimogene after TURBT (transurethral resection of bladder tumor) as part of the experimental treatment arm. Studies found that 75.5% of patients experienced a complete response, meaning their cancer was not detectable at some point during treatment. For many patients, this response lasted more than 28 months, with 58.3% maintaining this complete response for over 24 months. This treatment specifically targets and destroys cancer cells. These results suggest that cretostimogene grenadenorepvec could be an effective option for people with bladder cancer. ^{4 6 7 8 9}

Who Is on the Research Team?

Robert Svatek, MD

Principal Investigator

University of Texas Health Science Center San Antonio

Are You a Good Fit for This Trial?

This trial is for people with a type of bladder cancer called Intermediate Risk Non-Muscle Invasive Bladder Cancer (IR-NMIBC). Participants should have had certain low-grade tumors treated within the last 12 months or high-grade tumors smaller than 3 cm, and all visible disease must be removed recently. They need to have good organ function.

Inclusion Criteria

My organs are functioning well.

My bladder cancer has come back within a year or is larger/multiple low-grade tumors.

My low-grade T1 tumor was completely removed recently.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants in Arm A receive an induction course and quarterly maintenance courses of cretostimogene through Month 13, if there is no disease recurrence.

13 months

Quarterly visits for maintenance courses

Observation

Participants in Arm B are observed after TURBT for disease recurrence.

Up to 24 months

Every 3 months for the first 2 years

Follow-up

Participants are monitored for safety and effectiveness after treatment or observation.

3 years

Every 6 months for an additional year or until disease recurrence

Extension

Participants in Arm B who recur with IR-NMIBC after TURBT and observation will be offered treatment with cretostimogene.

As per treatment schedule in Arm A

What Are the Treatments Tested in This Trial?

Interventions

• Cretostimogene Grenadenorepvec

Trial Overview The study compares two approaches after tumor removal surgery (TURBT): one group receives an experimental therapy called Cretostimogene Grenadenorepvec, while the other group is just observed without additional treatment. The goal is to see which method is better at preventing cancer recurrence.

How Is the Trial Designed?

Group I: Cretostimogene after TURBT Experimental Treatment 2 Interventions

Following screening confirmation of IR-NMIBC and complete resection of the tumor, participants will be treated with adjuvant cretostimogene.

Group II: Observation after TURBT Active Control 1 Intervention

Following screening confirmation of IR-NMIBC and complete resection of tumor, participants will enter surveillance. Participants who recur with IR-NMIBC after TURBT and surveillance will be offered treatment with cretostimogene as per the treatment schedule in Arm A. This arm will be called the Extension Arm.

Who Is Running the Clinical Trial?

CG Oncology, Inc.

Lead Sponsor

Trials

9

Recruited

900+

Citations

1. ir.cgoncology.com ir.cgoncology.com/news-releases/news-release-details/cretostimogene-grenadenorepvec-data-continues-demonstrate-best

Cretostimogene Grenadenorepvec Data Continues to ... Latest BOND-003 data show 75.5% of patients achieved a complete response at any time – – Median duration of response exceeds 28 months and ...

2. auajournals.org auajournals.org/doi/10.1097/01.JU.0001111604.90306.91.02

BOND-003 COHORT C- PHASE 3, SINGLE-ARM STUDY ... BOND-003 (NCT044552591) is a phase-3 study evaluating the efficacy and safety of cretostimogene in patients with HR BCG-UR NMIBC.

3. urotoday.com urotoday.com/trials-in-progress/pivot-006-trial/videos/5131-phase-3-trial-results-for-intravesical-cretostimogene-grenadenorepvec-in-bladder-cancer-mark-tyson.html

Phase 3 Trial Results for Intravesical Cretostimogene ... Mark Tyson shares comprehensive cretostimogene grenadenorepvec data with Sam Chang, explaining this oncolytic immunotherapy's dual mechanism ...

4. ascopubs.org ascopubs.org/doi/10.1200/JCO.2025.43.5_suppl.TPS902

Expanded access program of cretostimogene ... Cretostimogene grenadenorepvec is an oncolytic immunotherapy with a dual mechanism of action. It selectively replicates and lyses bladder cancer ...

5. cgoncology.com cgoncology.com/cg-oncology-announces-bond-003-topline-results-aua-2025/

CG Oncology Announces Best-in-Disease Durability Data ... Robust 24-month complete response rate of 42.3% by KM for cretostimogene monotherapy in BOND-003 Cohort C. 58.3% of patients showed durable complete responses ...

6. cgoncology.com cgoncology.com/cretostimogene-grenadenorepvec-data-continues-to-demonstrate-best-in-class-durability-of-response-as-well-as-consistent-and-compelling-safety-and-efficacy/

Cretostimogene Grenadenorepvec Data Continues to ... Latest BOND-003 data show 75.5% of patients achieved a complete response at any time – – Median duration of response exceeds 28 months and ...

7. cgoncology.com cgoncology.com/science/

NMIBC | MIBC | Mechanism of Action of CG0070 Cretostimogene grenadenorepvec is an oncolytic immunotherapy with a dual mechanism of action that selectively replicates in and lyses cancer cells.

8. clinicaltrials.gov clinicaltrials.gov/study/NCT06111235

NCT06111235 | A Study of Adjuvant Cretostimogene ... This is a Phase 3, open-label, randomized trial designed to evaluate the RFS of TURBT followed by cretostimogene grenadenorepvec versus TURBT followed by ...

9. urotoday.com urotoday.com/conference-highlights/eau-2025/eau-2025-press-releases/159230-cretostimogene-grenadenorepvec-data-continues-to-demonstrate-best-in-class-durability-of-response-as-well-as-consistent-and-compelling-safety-and-efficacy.html

Cretostimogene Grenadenorepvec Data Continues to ... “Cretostimogene's strong safety and efficacy profile, combined with its best-in-class durability, address an unmet need for my non-muscle invasive bladder ...