190 Participants Needed

CG0070 for Bladder Cancer

(BOND-003 Trial)

Recruiting at 88 trial locations
AC
JH
PK
Overseen ByPat Keegan
No Placebo GroupAll 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 DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This is a Phase 3, open-label, single arm trial designed to evaluate Cretostimogene patients with NMIBC who have failed prior BCG therapy. Up to approximately 115 CIS bladder cancer patients with or without HG Ta or HG T1 papillary disease will be enrolled under the original protocol through Amendment 4, which will comprise Cohort C. Cohort C is closed to enrollment.Under Amendment 5-1, Cohort P was added to enroll up to 70 patients with HG Ta/T1 papillary bladder cancer.Under Amendment 6, the target number of patients enrolled in Cohort P was increased to 75. Cohort P is open to enrollmentCohort C and Cohort P will be analyzed and reported separately. Patients will have had to fail prior BCG therapy which is defined as having persistent or recurrent disease within 12 months (Cohort C) or 6 months (Cohort P) following the completion of adequate BCG therapy for HGUC

Will I have to stop taking my current medications?

The trial protocol does not specify whether you need to stop taking your current medications. However, it mentions that you should not have received systemic anti-cancer therapy within 4 weeks of starting the trial, and certain intravesical therapies are restricted close to the trial start date.

How is the treatment CG0070 different from other bladder cancer treatments?

CG0070 is a unique treatment for bladder cancer because it is an oncolytic virus that specifically targets and kills cancer cells with a defective retinoblastoma pathway, unlike traditional therapies. It is administered directly into the bladder (intravesical infusion) and is particularly used for patients who do not respond to the standard Bacillus Calmette-Guerin (BCG) treatment.12345

What data supports the effectiveness of the drug CG0070 for bladder cancer?

The research highlights the potential of targeted therapies for bladder cancer, with various drugs showing promise based on specific biomarkers. While CG0070 is not directly mentioned, the study of antibody-drug conjugates and other targeted therapies suggests that personalized approaches, like CG0070, could be effective for certain patients with bladder cancer.678910

Who Is on the Research Team?

CO

CG Oncology

Principal Investigator

CG Oncology

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I have completed the recommended BCG therapy.
My organs are working well.
I can take care of myself and am up and about more than half of my waking hours.
See 2 more

Exclusion Criteria

You currently have an autoimmune disease that is not under control.
I haven't had any cancer treatment or been in a trial for new treatments in the last 4 weeks.
I have a weakened immune system due to long-term steroid use, HIV, or an organ transplant.
See 4 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Cretostimogene is administered weekly for 6 weeks. If recurrence occurs at Week 13, a second induction of 6 weekly treatments is given. If no recurrence, 3 weekly treatments every 12 weeks through Week 51, then every 6 months through Month 36.

36 months
Weekly visits for initial 6 weeks, then every 12 weeks, and every 6 months

Follow-up

Participants are monitored for safety and effectiveness after treatment completion

12 months

Extension

Participants receive additional treatments every 6 months starting at Weeks 73, 74, and 75 through Week 159 if no tumor recurrence

36 months

What Are the Treatments Tested in This Trial?

Interventions

  • CG0070
Trial Overview 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.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Group I: Cohort P(Japan and United States Only) :Open to EnrollmentExperimental Treatment2 Interventions
Group II: Cohort C(All Countries):Enrollment ClosedExperimental Treatment2 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

CG Oncology, Inc.

Lead Sponsor

Trials
9
Recruited
900+

Published Research Related to This Trial

A study analyzed the protein expression of various cancer targets in different subtypes of bladder cancer, revealing that a significant percentage of patients could be eligible for targeted therapies: 58.9% of small cell neuroendocrine carcinoma (SCC) patients, 33.5% of adenocarcinomas (AC) and urachal carcinomas (UrC) patients, and 79.3% of squamous-differentiated bladder cancers (Sq-BLCA) patients.
The research suggests that personalized treatment options based on biomarker status could improve therapeutic outcomes for patients with nonurothelial bladder cancer, as many could benefit from specific targeted therapies.
Evaluation of Therapeutic Targets in Histological Subtypes of Bladder Cancer.Wucherpfennig, S., Rose, M., Maurer, A., et al.[2021]
Antibody-drug conjugates (ADCs) like enfortumab vedotin and sacituzumab govitecan have shown significant efficacy in treating advanced urothelial carcinoma, with enfortumab vedotin being effective alone or in combination with pembrolizumab, and both having received FDA approval.
Common side effects of these treatments include rash and neuropathy for enfortumab vedotin, and myelosuppression and diarrhea for sacituzumab govitecan, highlighting the importance of monitoring patient safety during therapy.
Antibody-drug conjugates for urothelial carcinoma.Thomas, J., Sun, M., Getz, T., et al.[2023]
Urothelial carcinoma remains a significant health challenge, with advanced cases having a median overall survival of nearly 1 year despite being sensitive to chemotherapy, highlighting the urgent need for new treatment options.
Emerging therapies, including new cytostatic agents and targeted therapies such as anti-EGFR and PI3K/mTOR inhibitors, are currently being evaluated in clinical trials, indicating a shift towards more innovative treatment strategies for this cancer.
Emerging therapies for urothelial cancer.Serrano, C., Morales, R., Suárez, C., et al.[2012]

Citations

Evaluation of Therapeutic Targets in Histological Subtypes of Bladder Cancer. [2021]
Antibody-drug conjugates for urothelial carcinoma. [2023]
Emerging therapies for urothelial cancer. [2012]
Conceptual Framework for Therapeutic Development Beyond Anti-PD-1/PD-L1 in Urothelial Cancer. [2019]
MEK is a promising target in the basal subtype of bladder cancer. [2020]
AdCD40L immunogene therapy for bladder carcinoma--the first phase I/IIa trial. [2021]
Bacillus Calmette-Guérin versus gemcitabine for intravesical therapy in high-risk superficial bladder cancer: a randomised prospective study. [2022]
Intravesical Infusion of Oncolytic Virus CG0070 in the Treatment of Bladder Cancer. [2023]
An open label, single-arm, phase II multicenter study of the safety and efficacy of CG0070 oncolytic vector regimen in patients with BCG-unresponsive non-muscle-invasive bladder cancer: Interim results. [2018]
Replacement Instead of Discontinuation of Bacillus Calmette-Guérin Instillation in Non-Muscle-Invasive Bladder Cancer. [2023]
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