Ensayos clínicos

Inclusion Criteria:

• Is ≥ 18 years of age (or legal age of majority in the jurisdiction) on day of signing informed consent.
• Has Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.
• Has the below, pathologically confirmed within 12 weeks of study registration:
  • Low-grade Ta recurrent within 12 months of prior low-grade or high-grade tumor;
  • Solitary low-grade Ta > 3 cm;
  • Low-grade Ta multifocal;
  • High-grade Ta ≤ 3 cm;
  • Low-grade T1.
• Has had all visible disease removed by TURBT at baseline within 10 weeks of study enrollment, prior to study treatment or initiation of observation period.
• Demonstrates 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 patients with total bilirubin levels > 1.5 × ULN;
  • Absolute neutrophil count (ANC) ≥ 1,000 cells/mm^3;
  • Hemoglobin ≥ 8 g/dL or ≥ 4.96 mmol/L;
  • Platelet count ≥ 100,000 platelets/mm^3;
  • Serum creatinine ≤ 1.5 × ULN or creatinine clearance ≥ 30 mL/min for patients with creatinine levels > 1.5 × institutional ULN according to the 2021 Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) creatinine equation;
  • Serum chemistries: Sodium, potassium, and calcium within normal limits or Grade 1;
  • Is willing to use barrier contraception, as outlined in Section 15.F, during sexual activity, starting at least 14 days prior to Day 1 until 6 weeks after the last dose of CG0070;
  • Is willing to comply with study-mandated cystoscopies, urine cytology, CT urogram, biopsies, and other procedures (including TURBT or other resection for all visible disease). Patients who withdraw consent for these procedures will be withdrawn from the trial.

Exclusion Criteria:

• Has current or prior evidence of high-risk NMIBC defined as:
  • High grade T1 • High grade Ta > 3 cm (or multifocal) • Any carcinoma in situ (CIS);
  • Any variant histology;
  • Any high grade prostatic urethral involvement;
  • Any lymphovascular invasion;
  • Any high-grade Bacillus Calmette-Guerin (BCG) or other treatment failure.
• Has disease that cannot be completely resected.
• Low-risk NMIBC defined as low-grade solitary Ta ≤ 3 cm if not recurrent within 12 months of a previous high-grade or low-grade tumor.
• Has current or history of muscle-invasive (T2 or higher stage) bladder cancer 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 (i.e., kidneys, renal collecting systems, ureters) or prostatic urethra (including CIS of the urethra) within 12 months prior to study enrollment.
• Has received systemic anti-cancer therapy, including investigational agents, within 4 weeks of Day 1:
  • NOTE: Patients who have entered the follow-up phase of an investigational study may participate if it has been at least 4 weeks after the last dose of the previous investigational agent.
• Has had any of the following within 6 months prior to study enrollment: 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 CG Oncology to discuss any anti-viral medication that cannot be discontinued.
• Has had prior treatment with any human adenovirus serotype 5 based therapy (e.g., Ad-interferon or Adstiladrin).
• 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: 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 enrollment or during study treatment. Corticosteroids may not be used for premedication;
  • NOTE: Patients with contrast dye allergies may be given 1–3 dose(s) of a systemic steroid to complete a contrast-enhanced CT urogram. There must be a minimum of 14 days from the steroid dose until administration of CG0070.
• 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. Patients with active acute or active chronic Hepatitis B or C, who take medications with anti-Hepatitis B or C activity are ineligible:
  • Patients who have evidence of hepatic decompensation or cirrhosis on physical exam, laboratory, pathologic or radiographic testing also are ineligible;
  • Patients with inactive chronic Hepatitis B infection (asymptomatic healthy carriers) who meet the trial-defined laboratory parameters are eligible for trial entry;
  • NOTE: No testing for Hepatitis B and Hepatitis C is required unless mandated by a local health authority.
• Has received prior radiotherapy within 2 weeks of start of study treatment. Patients must have recovered from all radiation-related toxicities, not require corticosteroids, and not have had radiation pneumonitis. A 1-week washout is permitted for palliative radiation (≤ 2 weeks of radiotherapy) to non-CNS disease.
• Has a known additional malignancy that, in the opinion of the treating physician, may interfere with the study conduct or require on study treatment for the malignancy.
• Has an active infection requiring systemic therapy (e.g., urinary tract infection or other active infection).
• Has received a live replication competent vaccine within 30 days prior to the first dose of study drug. Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, varicella/zoster (chicken pox), yellow fever, rabies, BCG, and typhoid vaccine. Seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed; however, intranasal influenza vaccines (e.g., FluMist®) are live attenuated vaccines and are not allowed:
  • NOTE: COVID-19 vaccination is allowed but please contact CG Oncology if the patient has received, or plans to receive, live replication competent COVID19 vaccination and document the date and type of COVID-19 vaccine received.
• Has not recovered (i.e., to ≤ Grade 1 or to Baseline status) from adverse events (AEs) due to a previously administered agent or therapy:
  • NOTE:
    • Patients with ≤ Grade 2 neuropathy or patients having any alopecia are an exception to this criterion and may qualify for the study;
    • If the patient received major surgery, they must be at least 4 weeks from surgery and have recovered adequately from the toxicity and/or complications from the surgery prior to starting study treatment;
    • Patients receiving prior radiation must have recovered ( < Grade 1) from any acute toxicity;
    • Patients having irreversible but not clinically significant toxicity are eligible.
• Has an illness, metabolic dysfunction, physical examination finding, or clinical laboratory finding that gives reasonable suspicion of a disease or condition that would contraindicate study treatment or that would limit compliance with study requirements.
• Is pregnant, currently breastfeeding or intending to breastfeed, within the projected duration of the trial beginning at Screening through 6 weeks after the last study treatment.
• Cannot tolerate study-related biopsies, intravesical (IVE) administration, or 1-hour bladder hold of CG0070.
• Has had IVE therapy within 12 weeks prior to beginning study treatment with the exception of cytotoxic agents (e.g., Mitomycin C, gemcitabine, doxorubicin, and epirubicin) when administered as a single instillation immediately following a TURBT procedure:
  • NOTE: Patients may be treated with a single dose of IVE chemotherapy immediately following TURBT prior to study enrollment at the discretion of the Investigator.

Note: Other protocol defined Inclusion/Exclusion Criteria may apply.

Eligibility last updated 8/23/23. Questions regarding updates should be directed to the study team contact.