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Virus Therapy

CG0070 for Bladder Cancer (CORE-001 Trial)

Phase 2
Waitlist Available
Led By James Burke
Research Sponsored by CG Oncology, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights

CORE-001 Trial Summary

This trial is testing a new cancer treatment for people with bladder cancer that has not responded to other treatments.

Eligible Conditions
  • Non-muscle Invasive Bladder Cancer

CORE-001 Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 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
Secondary outcome measures
Incidence of adverse events when CG0070 administered intravesically when combined with pembrolizumab.
Median duration of response (DoR)
Median overall survival (OS)
+1 more

CORE-001 Trial Design

1Treatment groups
Experimental Treatment
Group I: Single ArmExperimental Treatment3 Interventions
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 Day 1 to Week 6. If the patient shows persistent high-grade disease at Week 12, the patient will receive another cycle of 6 weekly treatments. If there is no disease present at Week 12 (e.g., complete response) then the patient will receive 3 weekly treatments. Beginning at Week 24, patients will receive weekly x 3 treatments every 3 months through Week 48 then every 24 weeks thereafter. Pembrolizumab will be given intravenous (IV) concurrently starting on Day 1 and continue every 3 weeks for up to 2 years.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pembrolizumab Injection
2019
Completed Phase 2
~120
CG0070
2015
Completed Phase 2
~70

Find a Location

Who is running the clinical trial?

CG Oncology, Inc.Lead Sponsor
6 Previous Clinical Trials
645 Total Patients Enrolled
Merck Sharp & Dohme LLCIndustry Sponsor
3,886 Previous Clinical Trials
5,054,536 Total Patients Enrolled
James BurkePrincipal InvestigatorCG Oncology, Inc.

Frequently Asked Questions

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

How does CG0070 impact patients safety?

"CG0070's efficacy has not been proven, but it did receive a score of 2 for safety."

Answered by AI

Are there any open slots for participants in this research?

"According to the latest information available on clinicaltrials.gov, this particular trial is not looking for new candidates at the moment. The study was first made public on December 8th 2020 but has not been updated since August 22nd of 2022. Although this research is closed to recruitment, there are 1,331 other trials that are still open and enrolling patients."

Answered by AI

Is this the first time CG0070 has been looked at in a scientific capacity?

"City of Hope first began studying CG0070 in 2010 and there have been 248 completed trials to date. There are 1002 open studies at the moment, a large concentration of which are taking place in Lancaster, Pennsylvania."

Answered by AI

Is this trial popular in the United States?

"This clinical trial is currently enrolling patients at 13 sites across the United States. The sites are located in Lancaster, Baltimore, Orange, and other cities. If you enroll in the trial, it is important to select a location that is nearest to you to minimize travel requirements."

Answered by AI

For what purpose is CG0070 most often prescribed?

"CG0070 is most frequently used to treat patients with malignant neoplasms. However, this medication can also be effective in managing unresectable melanoma, microsatellite instability high, and chemotherapy-resistant disease progression."

Answered by AI

How many individuals are included in this test?

"Unfortunately, this particular clinical trial is not currently enrolling patients. Although, it's worth noting that the last update was on 8/22/2022 and the study originally posted on 12/8/2020. There are other329 trials actively recruiting participants with urinary bladder cancer and 1002 studies for CG0070 actively recruiting participants if you're interested in finding another study to join."

Answered by AI
~8 spots leftby Apr 2025