A Study to Evaluate Adze1.C in Participants With Metastatic Melanoma

Korábbi kezelés

• Uncontrolled intercurrent illness, including but not limited to:
  • Active systemic infection or fever ≥ 38°C within 5 days prior to Screening
  • Symptomatic congestive heart failure
  • NYHA Class III or IV heart failure
  • Unstable angina or arrhythmia
  • Leptomeningeal disease, active uncontrolled or symptomatic brain metastases, CNS haemorrhage, uncontrolled peri-tumoural oedema, or conditions associated with high risk of CNS inflammation
  • Psychiatric illness or social conditions that limit compliance
• Prior treatment with adenovirus therapy.
• Prior oncolytic virus treatment within 2 months of Screening.
• Use of systemic immunosuppressants or other immune-modifying drugs must be discontinued 14 days prior to the first dose.

Más betegség

• Visceral metastatic disease that is not clinically and radiographically stable or requires urgent medical intervention.
• Immunocompromised status or known HIV infection with ongoing antiretroviral therapy.
• Active or clinically significant liver disease, including:
  • Hepatitis B surface antigen (HBsAg) positive
  • Hepatitis C virus RNA positive
• History of organ transplantation.
• Any other condition which, in the investigator's judgment, would make the participant inappropriate for the study.

Egyéb

• Use of cidofovir within 14 days of Adze1.C dosing.

• Male or female participants aged 18 years or older at Screening.
• Histologically confirmed unresectable Stage IIIB to IV metastatic melanoma.
• Refractory to, or unsuitable for, standard treatment options as determined by the investigator.
• Not a suitable candidate for curative resection.
• Presence of measurable disease per iRECIST (excluding irradiated lesions unless progression post-radiation is documented).
• Presence of at least one injectable melanoma lesion and/or tumor-involved lymph node suitable for intratumoral administration.
• ECOG performance status of 0 or 1 at Screening.
• Stable visceral metastases and stable CNS metastases may be eligible if protocol-defined eligibility requirements are met.
• Willing and able to provide written informed consent and comply with study procedures.