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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

Must not have

Systemic anti-cancer therapy, including investigational agents, within 4 weeks of Baseline

Immuno-deficient due to chronic steroid or other immunosuppressant use, HIV, or prior organ transplant

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 36 months

Awards & highlights

No Placebo-Only Group

Pivotal 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.

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I haven't had any cancer treatment or been in a trial for new treatments in the last 4 weeks.

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I have a weakened immune system due to long-term steroid use, HIV, or an organ transplant.

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I do not have any serious or active heart problems.

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I have been treated with adenovirus-based cancer therapy before.

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I have a known cancer in my upper urinary tract or prostate.

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My bladder cancer has spread beyond the bladder wall.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 36 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~36 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 36 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Cohort C

Cohort P

Secondary study objectives

Cohort C: Duration of response (DOR)

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

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.

0 / 10Eligibility criteria met