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 range18 Years
SexALL
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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…
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