The phase 1 study is an open label, multi-center, non-randomized, dose escalation and expansion study designed to assess the safety, tolerability, and immunogenicity of IMU-201(PD1-Vaxx) as monotherapy and in combination with Standard of Care (SOC) treatment in participants with PD-L1 expressing non-small cell lung cancer (NSCLC).
Investigational Medicinal Product, IMU-201, consists of drug substance, APi2568, which is a B-cell epitope (amino acids 92-110 from PD-1) linked to a promiscuous T-cell epitope (amino acid residues 288-302 from measles virus fusion protein) via a 4-amino acid linker (Gly-Pro-Ser-Leu), and combined with Water for Injection (WFI) forms the drug product, IMU-201, which becomes PD1-Vaxx when emulsified with excipient Montanide ISA 720 VG.
It is hypothesized that a polyclonal induced B-cell antibody response will be more effective or as effective with improved safety over current monoclonal antibody therapy.
This phase 1 study is designed to assess the safety, tolerability, and immunogenicity of IMU-201 (PD1-Vaxx) as monotherapy and in combination with Standard of Care (SOC) treatment in participants with PD-L1 expressing non-small cell lung cancer (NSCLC). The study consists of two parts. Part 1, monotherapy dose-escalation of IMU-201 (PD1-Vaxx) to establish an optimal biological dose as monotherapy (Part 1a) followed by a combination dose escalation with standard of care treatment to establish a combination optimal biological dose of IMU-201 (PD1-Vaxx)(Part 1b). Part 2 dose expansion, will further characterize the safety, tolerability, and immunogenicity of IMU-201 in combination with SOC treatment for NSCLC at the defined expansion dose-level from Part 1b.
|Treatment||IMU-201 (administered as PD1-Vaxx), Standard of care treatment for NSCLC|
|Clinical Study Identifier||NCT04432207|
|Last Modified on||6 October 2020|
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