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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 24 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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My organs are working well.
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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 ~24 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 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
Complete response rate in patients with carcinoma in situ (with or without concomitant high-grade Ta or T1 papillary disease)
Secondary outcome measures
Comparison of complete response in patients with persistent disease versus relapsed disease at baseline.
Incidence of adverse events when CG0070 administered alone.
Median Duration of response (DOR)
+2 more

BOND-003 Trial Design

1Treatment groups
Experimental Treatment
Group I: Single ArmExperimental Treatment2 Interventions
Patients with carcinoma in situ with or without concomitant high-grade Ta or T1 papillary disease. CG0070 will be administered intravesically (IVE) following a sequence of bladder washes with 5% DDM and normal saline. CG0070 will be administered weekly x 6 on Weeks 1, 2, 3, 4, 5, and 6. If the patient has persistent high-grade disease at Week 13, the patient will receive another cycle of 6 weekly treatments. If there is no disease present at Week 13 (e.g. complete response) then the patient will receive 3 weekly treatments. Beginning at Week 25, patients will receive weekly x 3 treatments every 12 weeks through week 49then every 24 weeks thereafter.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
CG0070
2015
Completed Phase 2
~70

Find a Location

Who is running the clinical trial?

CG Oncology, Inc.Lead Sponsor
6 Previous Clinical Trials
570 Total Patients Enrolled
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: Single Arm
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+
~25 spots leftby Mar 2025