First in Human Study With NG-641, an Oncolytic Transgene Expressing Adenoviral Vector
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- 42
Summary
- Conditions
- Epithelial Tumor
- Metastatic Cancer
- Type
- Interventional
- Phase
- Phase 1
- Design
- Allocation: Non-RandomizedIntervention Model: Sequential AssignmentMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
Description
To characterise the safety and tolerability of NG-641 in patients with metastatic or advanced epithelial tumours. The Phase Ia part of the study is a dose escalation and dose expansion phase investigating NG-641 administration by intratumorural injection (IT) and intravenous (IV) infusion in a range...
To characterise the safety and tolerability of NG-641 in patients with metastatic or advanced epithelial tumours. The Phase Ia part of the study is a dose escalation and dose expansion phase investigating NG-641 administration by intratumorural injection (IT) and intravenous (IV) infusion in a range of tumour types The Phase Ib part of the study is to investigate safety and efficacy of NG-641 as monotherapy or in combination with chemotherapy agents and/or checkpoint inhibitors in separate efficacy cohorts of patients with specific epithelial tumour types.
Tracking Information
- NCT #
- NCT04053283
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: Haesong Park, MD Washington University School of Medicine, St Louis, Missouri
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