Study of CG0070 After Transurethral Resection in Patients With IR NMIBC (NCT06253845) | Clinical Trial Compass
Active — Not RecruitingPhase 1
Study of CG0070 After Transurethral Resection in Patients With IR NMIBC
United States20 participantsStarted 2024-03-01
Plain-language summary
Investigators will evaluate the safety of CG0070 for the treatment of patients with Intermediate-Risk Non-Muscle Invasive Bladder Cancer (IR NMIBC).
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Have Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.
* Have pathologically confirmed:
* Recurrent Low-grade Ta
* Solitary Low-Grade Ta \> 3cm
* Low-grade Ta multifocal
* High-grade Ta ≤ 3cm
* 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). "Marker lesion" must be clearly identifiable and assessable in the judgment of the investigator. "Marker lesion" location and size must be documented by the investigator (e.g., via photography).
* Demonstrate adequate organ function, defined as:
* Aspartate transaminase (AST), alanine aminotransferase (ALT)
≤2.5 × upper limit of normal (ULN)
* Total serum bilirubin ≤1.5 × ULN (OR direct bilirubin ≤ULN for participants with total bilirubin levels \>1.5 × ULN)
* Absolute neutrophil count (ANC) ≥1,000 cells/mm3
* Hemoglobin ≥8 g/dL or ≥4.96 mmol/L
* Platelet count ≥100,000 platelets/mm3
* Serum creatinine ≤1.5 × ULN or creatinine clearance ≥30 mL/min for patient with creatinine levels \>1.5 institutional ULN according to Cockcroft-Gault formula
* Serum chemistries: Sodium, potassium, and calcium within normal limits (WNL) or Grade 1
* International normalized ratio (INR) or prothrombin time (PT) ≤1.5 × ULN unless receiving anticoagulation therapy and INR or PT is within the therapeutic range of…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Incidence of Treatment-Emergent Adverse Events
Timeframe: Up to 2 years
Trial details
NCT IDNCT06253845
SponsorH. Lee Moffitt Cancer Center and Research Institute