A Multicentre, Open Label, Non-randomised First in Human Study of NG-350A (Monotherapy), and NG-350A With a Check Point Inhibitor in Patients With Metastatic or Advanced Epithelial Tumours
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Metastatic Cancer
- Sponsor
- Akamis Bio
- Enrollment
- 28
- Locations
- 5
- Primary Endpoint
- Incidence of adverse events, serious adverse events, adverse events meeting protocol-defined DLT criteria, severe adverse events, adverse events leading to study treatment or study discontinuation, and adverse events resulting in death.
- Status
- Completed
- Last Updated
- 3 years ago
Overview
Brief Summary
This study will evaluate the safety, tolerability and preliminary efficacy and also pharmacokinetics, immunogenicity and other pharmacodynamic effects to elucidate the mechanism of action of NG-350A, either alone or in combination with a check point inhibitor, in patients with advanced or metastatic epithelial tumours.
Detailed Description
Phase Ia of this study is a dose escalation phase, investigating NG-350A administration by intravenous (IV) infusion, either alone or in combination with a check point inhibitor. Phase Ib of this study comprises of a Combination Dose Efficacy Expansion with NG-350A in combination with a check point inhibitor.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Provide written informed consent to participate
- •Aged 18 years or over
- •Have one of eleven histologically or cytologically confirmed metastatic or advanced carcinomas or adenocarcinomas that have progressed after at least one line of systemic therapy and are incurable by local therapy
- •a. Tumour types eligible are: UC, SCCHN, MSI high/dMMR cancer, NSCLC, uterine/endometrial cancer, cervical cancer, oesophageal cancer, gastric cancer, cutaneous squamous cell carcinoma, HCC and TNBC
- •Additional tumour type specific criteria:
- •UC: carcinoma of the renal pelvis, ureter, bladder, or urethra that showed predominantly transitional-cell features on histologic testing
- •SCCHN with oropharyngeal cancer: known HPV p16 status
- •MSI-high/dMMR cancer: MSI-high/dMMR status must be confirmed by an approved test
- •NSCLC: either squamous or non-squamous histology
- •Gastric cancer: gastric or gastroesophageal junction adenocarcinoma
Exclusion Criteria
- •Prior or planned allogeneic or autologous bone marrow or organ transplantation
- •Splenectomy
- •Active infections requiring antibiotics, physician monitoring or systemic therapy within 1 week of the anticipated first dose of study drug, or recurrent fevers (\>38.0˚C) associated with a clinical diagnosis of active infection
- •Active viral disease or positive test for hepatitis B virus using hepatitis B surface antigen test or positive test for hepatitis C virus (HCV) using HCV ribonucleic acid (RNA) or HCV antibody test indicating acute or chronic infection. Positive test for HIV or AIDS
- •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 systemic immunosuppressive treatment
- •a. Patients with vitiligo, type I diabetes mellitus, asthma/atopy, residual hypothyroidism due to autoimmune disease (which only requires hormone replacement therapy), or conditions not expected to recur in the absence of an external trigger are permitted to enrol providing they comply with the other eligibility criteria relating to renal function. Use of inhaled corticosteroids, local steroid injection, or steroid eye drops is allowed
- •Treatment with any live, live attenuated or COVID-19 vaccine in the 28 days before the first dose of NG 350A
- •a. COVID-19 vaccines known not to be based on an adenoviral vector (e.g. mRNA vaccines) are not subject to the 28-day exclusion (see exclusion criterion 7)
- •Treatment with any other vaccine (including known non-adenoviral COVID-19 vaccines) in the 7 days before first dose of NG-350A
- •History of prior Grade 3-4 acute kidney injury or other clinically significant renal impairment
Outcomes
Primary Outcomes
Incidence of adverse events, serious adverse events, adverse events meeting protocol-defined DLT criteria, severe adverse events, adverse events leading to study treatment or study discontinuation, and adverse events resulting in death.
Time Frame: Throughout study to end of study treatment visit (Week 24 or +30 days after last study drug dose)
Characterise the safety and tolerability of NG-350A, in combination with a check point inhibitor, by reviewing reported Adverse Events (AEs) and Serious Adverse Events (SAEs).