Clinical Trial 21690

• Overview

  Study Title:

  A Phase 1b, Single Arm Study of CG0070 after Transurethral Resection in Patients with Intermediate Risk Non-Muscle Invasive Bladder Cancer (IR NMIBC)

  Objective:

  Primary Objective: To evaluate the safety of CG0070 following diagnosis of IR NMIBC. Secondary Objectives: To evaluate complete response of IR NMIBC marker lesions to CG0070 and evaluate duration of response at 12 and 24 months from treatment start. Evaluate 12- and 24-month recurrence free survival rates in patients receiving CG0070 as adjuvant treatment of IR NMIBC following complete resection of persistent IR marker lesions in patients determined to be non-responders following first induction course. (Note: for non-responders the assessment of RFS will begin at the time of resection of disease at 3 months)

• Treatments

  Therapies:

  Immunotherapy; Therapy (NOS)

  Medications:

  CG0070 (); DDM ()

• Inclusion Criteria

  Key Inclusion Criteria:
  • Be at least 18 years of age (or legal age of majority in the jurisdiction) on day of signing informed consent
  • Have Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.
  • Have pathologically confirmed disease as defined by the protocol
  • Have all visible disease except a single "marker lesion"; of approximately 0.3 - 1; 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 as defined by the protocol
  • 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 Patients who withdraw consent for these procedures will be withdrawn from the trial.
  • Other inclusion criteria apply

• Exclusion Criteria

  Key Exclusion Criteria:
  • Current or prior evidence of high-risk NMIBC as defined by the protocol
  • Disease that is unable to be completely resected
  • Lack of marker lesion
  • Low-risk NMIBC as defined by the protocol
  • 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
  • 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
  • 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
  • Has received prior radiotherapy within 2 weeks of start of study treatment. Participants 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 to nonCNS 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.
  • 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, IVE administration, or 1-hour bladder hold of CG0070.
  • Other exclusions apply

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