A multicentre, open-label, non-randomized, phase 1a/1b study of NG-350A, a tumour-selective anti-CD40-expressing adenoviral vector in combination with pembrolizumab in patients with metastatic or advanced epithelial tumours

PsiOxus Therapeutics Ltd.0 个研究点目标入组 198 人开始时间: 2022年6月17日最近更新: 2022年8月5日

适应症

试验速览

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•1. Provide written informed consent to participate
•2. Aged 18 years or over on day of signing informed consent
•3. Patients must have one of eleven histologically or cytologically confirmed metastatic/advanced carcinomas or adenocarcinomas that has progressed after at least one line of systemic therapy and are incurable by local therapy
•4. At least one measurable site of disease according to RECIST v1.1 criteria; this lesion must be either (i) outside a previously irradiated area or (ii) progressive if it is in a previously irradiated area
•5. Prior treatment with a PD-1/PD-L1 inhibitor (prior PD-1/PD-L1 may have been given as monotherapy or combination therapy)
•6. Tumour accessible for biopsy, biopsy deemed safe by the Investigator, and patient willing to consent to tumour biopsies
•7. Ability to comply with study procedures in the Investigator’s opinion
•8. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1

•1. Prior or planned allogeneic or autologous bone marrow or tissue/organ transplantation
•2. Splenectomy
•3. Active infections requiring systemic anti-infective treatment, physician monitoring/hospital admission or recurrent fevers (>38.0°C) associated with a clinical diagnosis of active infection within 20 days of the anticipated first dose of study drug. Patients who have had an active infection requiring systemic therapy, but not hospital admission, which has resolved at least 10 days before the anticipated first dose of study drug are eligible
•4. Treatment with the antiviral agents: ribavirin, adefovir, lamivudine or cidofovir within 10 days prior to the first dose of study treatment; or pegylated interferon in the 4 weeks before the first dose of study treatment
•5. Known history of hepatitis B (defined as HBsAg reactive) or known active hepatitis C virus (defined as HCV RNA [qualitative] is detected) infection. Known history of HIV infection (no testing for HIV, hepatitis B or hepatitis C is required unless mandated by local health authority)
•6. Patients who have active autoimmune disease that has required systemic therapy in the past 2 years, are immunocompromised in the opinion of the Investigator, or are receiving chronic systemic immunosuppressive treatment (including steroid therapy in doses exceeding 10 mg daily of prednisone equivalent)
•7. Treatment with any live, live-attenuated or COVID-19 vaccine in the 30 days before first dose of study drug

发起方

PsiOxus Therapeutics Ltd.