Study of CG0070 After Transurethral Resection in Patients With IR NMIBC

Running, not enrolling · Phase 1

Conditions studied: Non-muscle Invasive Bladder Cancer

In brief

Investigators will evaluate the safety of CG0070 for the treatment of patients with Intermediate-Risk Non-Muscle Invasive Bladder Cancer (IR NMIBC).

Key facts

Study ID

NCT06253845

Run by

H. Lee Moffitt Cancer Center and Research Institute

People needed

20

Starts

2024-03-01

Expected to finish

2027-09-01

Last updated by the study team

2026-07-02

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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 intended use of anticoagulants. (NOTE: patients must be able to suspend, based on local practice, anticoagulant and anti-platelet therapy for study specific biopsies and procedures)
• Willing to use barrier contraception, as outlined in Section 6.6, during sexual activity, starting with Day 1 for up to 6 weeks after each dose of CG0070.
• Patients must be willing to comply with study mandated cystoscopies, urine cytology, CT urograms, biopsies, and other procedures (including transurethral resection of bladder tumor [TURBT] or other resection for all visible disease). Patients who withdraw consent for these procedures will be withdrawn from the trial.

You may not qualify if…

• Current or prior evidence of high-risk NMIBC defined as:
• HG T1
• Any recurrent HG (G3) Ta
• HG Ta > 3 cm (or multifocal)
• Any CIS
• Any BCG exposure in HG patient
• Any variant histology
• Any LVI
• Any HG prostatic urethral involvement
• Disease that is unable to be completely resected
• Lack of marker lesion
• Low-risk NMIBC defined as:
• Low grade solitary Ta less than or equal to 3cm
• Papillary urothelial neoplasm of low malignant potential
• Has current or past history of muscle invasive (T2 or higher stage) or locally advanced (T3/T4, any N) or metastatic bladder cancer
• Has history of high grade or low grade urothelial carcinoma in the upper genitourinary tract (kidneys, renal collecting systems, ureters) or prostatic urethra (including CIS of the urethra) within 12 months of enrollment
• Has received systemic anti-cancer therapy, including investigational agents, within 4 weeks of Day 1 NOTE: For participants who have entered the follow-up phase of an investigational study may participate if it has been 4 weeks after the last dose of the previous investigational agent
• Has any of the following within 6 months prior to starting study treatment: untreated myocardial infarction, untreated severe/unstable angina, coronary/peripheral artery bypass graft, cerebrovascular accident, pulmonary embolus, uncontrolled hypertension, or uncontrolled congestive heart failure that is deemed to be preventative from the patient completing study intervention and/or assessment.
• Has used excluded anti-viral medication (e.g., interferon/peg-interferon, ribavirin, etc.) within 14 days of Day 1 and that cannot be suspended throughout for at least 14 days prior to and after each treatment with CG0070. Please consult with sponsor to discuss any anti-viral that cannot be discontinued.
• Has had prior treatment with any human adenovirus serotype 5 based therapy (e.g., Ad-interferon or Adstiladrin/Instiladrin/nadofaragene firadenovec)
• Requires use of anti-platelet or anti-coagulant therapy that cannot be safely suspended for per protocol biopsies and other procedures as per standard of care
• Has significant immunodeficiency due to underlying illness (e.g., known HIV/AIDS). Note that HIV testing is not mandatory unless required by local health authorities.
• Has received systemic immunosuppressive medication including high-dose corticosteroids (e.g. systemic corticosteroids >10 mg prednisone or equivalent) within 28 days prior to Day 1. NOTE: Patients must not be receiving doses of >10 mg/day of prednisone or equivalent at the time of study entry or during the study and corticosteroids may not be used for premedication
• Has had an allogeneic tissue/solid organ transplant
• Has a known history of Hepatitis B (defined as HBsAg reactive) or known active Hepatitis C virus (defined as HCV RNA [qualitative] is detected) infection

Where it is running

• Moffitt Cancer Center — Tampa, Florida, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.