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Virus Therapy

CG0070 for Bladder Cancer

Phase 1

Recruiting

Led By Roger Li, MD

Research Sponsored by H. Lee Moffitt Cancer Center and Research Institute

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Have Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2

Have all visible disease except a single 'marker lesion' of approximately 0.3 - 1 cm diameter removed at baseline prior to initial CG0070 treatment (photographic documentation of lesion location and size must be conducted)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 2 years

Awards & highlights

Study Summary

This trial will assess how safe CG0070 is as a treatment for patients with a certain type of bladder cancer called Intermediate-Risk Non-Muscle Invasive Bladder Cancer (IR NMIBC).

What is being tested?

This trial is focused on assessing the safety of a treatment called CG0070 for patients with Intermediate-Risk Non-Muscle Invasive Bladder Cancer (IR NMIBC).See study design

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I can take care of myself and am up and about more than half of my waking hours.

Select...

All my visible cancer, except one small area, has been removed before starting CG0070 treatment.

Select...

My blood tests show my organs are functioning well.

Select...

My bladder cancer is confirmed to be a specific type and stage.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Incidence of Treatment-Emergent Adverse Events

Secondary outcome measures

12-month recurrence free survival rate (RFS)

24-month recurrence free survival rate (RFS)

Complete Response Rate (CR)

+2 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: CG0070Experimental Treatment1 Intervention

CG0070 is a conditionally replicating oncolytic adenovirus (serotype 5) designed to preferentially replicate in and kill cancer cells.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

CG0070

2015

Completed Phase 2

~70

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

H. Lee Moffitt Cancer Center and Research InstituteLead Sponsor

543 Previous Clinical Trials

135,462 Total Patients Enrolled

Roger Li, MDPrincipal InvestigatorMoffitt Cancer Center

1 Previous Clinical Trials

21 Total Patients Enrolled

Frequently Asked Questions

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

What is the total number of participants being selected for enrollment in this clinical trial?

"Yes, information on clinicaltrials.gov shows that this trial is actively seeking volunteers. The trial was first listed on 2/1/2024 and was last modified on 2/2/2024. They aim to recruit 20 participants at a single site."

Answered by AI

Is this medical study currently open for enrollment?

"Indeed, based on the details available on clinicaltrials.gov, it appears that this investigation is actively enrolling participants. Originally shared on February 1st, 2024 and most recently revised on February 2nd, 2024, the research project aims to recruit a total of 20 patients from a single designated site."

Answered by AI

What is the level of risk associated with CG0070 for individuals receiving treatment?

"Our research team at Power rates the safety of CG0070 as 1 on a scale from 1 to 3. This assessment aligns with it being in Phase 1, indicating minimal available data on both its safety and efficacy."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Study of CG0070 After Transurethral Resection in Patients With IR NMIBC

2024. "Study of CG0070 After Transurethral Resection in Patients With IR NMIBC". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06253845.

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