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Virus Therapy

CG0070 for Bladder Cancer (BOND-003 Trial)

Phase 3
Recruiting
Led By James Burke, MD
Research Sponsored by CG Oncology, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Received prior adequate BCG therapy as defined
Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 60 months
Awards & highlights

BOND-003 Trial Summary

This trial will test the effectiveness of CG0070, given through the bladder, in patients with NMIBC that has not responded to BCG treatment.

Who is the study for?
This trial is for adults with high-risk non-muscle invasive bladder cancer that hasn't responded to BCG therapy. Participants should be in fair to good physical condition (ECOG 0-2), not eligible or unwilling to undergo radical cystectomy, and have proper organ function. Those with muscle-invasive, advanced, or metastatic bladder cancer, other malignancies in the urinary tract, recent systemic anti-cancer treatments, immune deficiencies including HIV or past organ transplants are excluded.Check my eligibility
What is being tested?
The study tests CG0070 given directly into the bladder of patients who haven't responded to BCG treatment for their bladder cancer. It aims to see how effective this approach is. The intervention involves a compound called n-dodecyl-B-D-maltoside alongside CG0070 as part of the treatment process.See study design
What are the potential side effects?
Potential side effects may include irritation within the bladder where CG0070 is administered, typical reactions related to intravesical therapies such as discomfort during urination, increased frequency of urination and blood in urine. Systemic side effects could occur but are less common.

BOND-003 Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have completed the recommended BCG therapy.
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I can take care of myself and am up and about more than half of my waking hours.
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My bladder cancer is high-risk and hasn't responded to BCG therapy.
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I cannot undergo or refuse to have major bladder surgery.

BOND-003 Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 60 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 60 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Cohort C
Cohort P
Secondary outcome measures
Cohort C and Cohort P : Cystectomy free survival
Cohort C and Cohort P: Assess high-grade reoccurrence free survival (RFS)
Cohort C and Cohort P: Assess progression free survival (PFS )
+5 more

BOND-003 Trial Design

2Treatment groups
Experimental Treatment
Group I: Cohort P(Japan and United States Only) :Open to EnrollmentExperimental Treatment2 Interventions
HG Ta/T1 papillary disease bladder cancer patients. In Cohort P, cretostimogene will be administered at a dose of 1 × 1012vp IVE following instillation of 5% DDM. Cretostimogene will be administered every week for 6 treatments on Weeks 1, 2, 3, 4, 5, and 6. If the patient has recurrence at Week 13 or any timepoint, the patient will receive a second induction of 6 weekly treatments (Weeks 13, 14, 15, 16, 17, and 18.). If the tumor has not returned they will receive 3 weekly treatments every 12 weeks (approximately 3 months) starting Weeks 13, 14, and 15 through Week 51 (approximately 12 months), and then every 6 months starting at Weeks 73, 74, and 75 (approximately 18 months) through Month 36.
Group II: Cohort C(All Countries):Enrollment ClosedExperimental Treatment2 Interventions
Patients with CIS with or without HG Ta/T1 papillary disease. Cretostimogene will be administered intravesically following a series of bladder washes with 5% DDM and normal saline. Cretostimogene will be administered weekly x 6 on Weeks 1, 2, 3, 4, 5, and 6. If the patient has disease recurrence at Week 13, they will receive another cycle of 6 weekly treatments. If there is no disease present at Week 13 then the patient will receive 3 weekly treatments. Cohort C(All Countries):Beginning at Week 25, patients will receive weekly x 3 treatments every 12 weeks through week 51 then every 6 months and then a last treatment at Weeks 73, 74, and 75 until the tumor returns or study treatment is completed at Week 97. Cohort C Extension( Japan and the US) At Week 25, patients will receive weekly x 3 treatments every 12 weeks through week 51 then every 6 months starting at Weeks 73, 74, and 75 through Weeks 157, 158, and 159 until the tumor returns or study treatment is completed at Week 159.

Find a Location

Who is running the clinical trial?

CG Oncology, Inc.Lead Sponsor
6 Previous Clinical Trials
570 Total Patients Enrolled
CG OncologyStudy DirectorCG Oncology
James Burke, MDPrincipal InvestigatorCG Oncology, Inc.
4 Previous Clinical Trials
213 Total Patients Enrolled

Media Library

CG0070 (Virus Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT04452591 — Phase 3
Bladder Cancer Research Study Groups: Cohort C(All Countries):Enrollment Closed, Cohort P(Japan and United States Only) :Open to Enrollment
Bladder Cancer Clinical Trial 2023: CG0070 Highlights & Side Effects. Trial Name: NCT04452591 — Phase 3
CG0070 (Virus Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04452591 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many patients are involved in this clinical trial?

"A total of 110 patients are needed to fill the quotas for this clinical trial. Eligible individuals can choose to participate at sites such as Chesapeake Urology in Severna Park, Maryland and Moffit Cancer Center in Tampa, Florida."

Answered by AI

Are patients currently able to sign up for this trial?

"The clinical trial is currently active and looking for 110 patients from 25 different sites. The first posting was on 10/27/2020, with the most recent edit occurring on 10/13/2022."

Answered by AI

Has CG0070 undergone the FDA's process of drug approval?

"CG0070 has undergone multiple rounds of testing, so it is estimated to be a safe medication with a score of 3."

Answered by AI

Does a history of CG0070 trials exist?

"The first clinical trials for CG0070 took place in 2020 at Moffitt Cancer Center. So far, 1 trial has been completed with 3 more active ones. These ongoing studies are based out of Severna Park, Maryland."

Answered by AI

In how many different medical clinics is this research study being conducted today?

"At the moment, this study is being conducted in 25 different locations. They are situated in Severna Park, Tampa, Spokane and 22 other places. If you decide to participate in this trial, choose the site that is closest to your home to limit travel required."

Answered by AI

Are there other similar clinical trials to this one?

"CG0070 is being trialed in 38 cities, across 5 nations. The first tests occurred in 2020 and were completed successfully; Phase 1 of the drug approval process was cleared. So far, 1 trial has been conducted since then."

Answered by AI

Who else is applying?

What state do they live in?
New York
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
What site did they apply to?
Our Lady of Lourdes
How many prior treatments have patients received?
3+
Recent research and studies
clinicaltrials.govStudy
Study of Cretostimogene Given in Patients With Non-Muscle Invasive Bladder Cancer ,Unresponsive to Bacillus-Calmette-Guerin
2020. "Study of Cretostimogene Given in Patients With Non-Muscle Invasive Bladder Cancer ,Unresponsive to Bacillus-Calmette-Guerin". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04452591.
All > Bladder Cancer
~96 spots leftby Dec 2027
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