A Multicentre, Open-label, Non-randomised First in Human Study of NG-641, a Tumour Selective Transgene Expressing Adenoviral Vector, in Patients With Metastatic or Advanced Epithelial Tumours (STAR)
Description
Brief Summary
To characterise the safety and tolerability of NG-641 in patients with metastatic or advanced
epithelial tumours.
Detailed Description
To characterise the safety and tolerability of NG-641 in patients with metastatic or advanced
epithelial tumours.
The Phase 1a part of the study is a dose-escalation and dose-optimization phase investigating
NG-641 administration by intravenous (IV) infusion in a range of tumour types.
The Phase 1b part of the study will investigate the selected optimized multicycle dosing
regimen as a monotherapy in up to three cohorts of patients with specific tumour types (Dose
Expansion Cohorts A, B and C).
Phase
N/AInclusion and Exclusion Criteria
- Phase 1a: - Histologically or cytologically documented metastatic or advanced epithelial cancer that has relapsed from or is refractory to standard treatment, or for which no standard treatment is available All patients
- Provide written informed consent to participate
- At least one measurable site of disease according to RECIST Version 1.1 criteria
- Tumour accessible for biopsy, biopsy deemed safe by the Investigator, and patient willing to consent to tumour biopsies
- Ability to comply with study procedures in the Investigator's opinion
- Aged 18 years or over
- ECOG performance status 0 or 1
- Predicted life expectancy of 6 months or more
- Adequate lung reserve
- Adequate renal function
- Adequate hepatic function
- Adequate bone marrow function
- Meeting reproductive status requirements
- Prior or planned allogenic 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
Sites
Please contact the trial administrator to learn more about where you can participate in this trial. Please use the contact form on the right side.
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