Trials / Terminated

TerminatedNCT04432207

A Study of IMU-201 (PD1-Vaxx), a B-Cell Immunotherapy, in Adults With Non-Small Cell Lung Cancer

An Open Label, Multi-Center, Dose Escalation/Expansion, Phase 1/1b Study of IMU-201, a B-Cell Immunotherapy as Monotherapy or in Combination With Atezolizumab With or Without Chemotherapy, in Adults With Non- Small Cell Lung Cancer (IMPrinter)

Status: Terminated
Phase: Phase 1
Study type: Interventional
Enrollment: 24 (actual)

Sponsor: Imugene Limited · Industry
Sex: All
Age: 18 Years
Healthy volunteers: Not accepted

Summary

An Open Label, Multi-Center, Dose Escalation/Expansion, Phase 1/1b Study of IMU 201 (PD1-Vaxx), a B-Cell Immunotherapy as monotherapy or in combination with atezolizumab with or without chemotherapy, in Adults with Non-Small Cell Lung Cancer (IMPrinter).

Detailed description

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 1/1b study is an open-label dose escalation/dose expansion study designed to assess the safety, tolerability, immunogenicity and efficacy of IMU-201 (PD1-Vaxx). Phase 1 monotherapy dose-escalation of IMU-201 (PD1-Vaxx), will enroll approximately 9-18 patients and establish the optimal monotherapy biological dose (mBOD). Once established, the dose cohort will be expanded to enroll additional 10 patients at the mBOD dose level. Phase 1b, a combination dose-escalation of IMU-201 (PD1-Vaxx) with atezolizumab and with or without chemotherapy, will enroll approximately 18-36 patients and establish the optimal combotherapy biological dose (cBOD). Once established, the dose cohort will be expanded to enroll additional 30 patients at the cBOD dose level.

Conditions

Interventions

Type	Name	Description
BIOLOGICAL	IMU-201 (administered as PD1-Vaxx) - Regimen 1	IMU-201 consists of APi2568 (lyophilized IMU-201) dissolved in WFI and emulsified with the adjuvant (Montanide ISA 720 VG) to produce PD1-Vaxx. IMU-201 will be administered as PD1-Vaxx intramuscularly into the deltoid region of the upper arm on Days 1, 15, 29, 64 and thereafter every 63 days until discontinuation from study.
BIOLOGICAL	IMU-201 (administered as PD1-Vaxx) - Regimen 2	IMU-201 consists of APi2568 (lyophilized IMU-201) dissolved in WFI and emulsified with the adjuvant (Montanide ISA 720 VG) to produce PD1-Vaxx. IMU-201 will be administered as PD1-Vaxx intramuscularly into the deltoid region of the upper arm on Days 1, 15, 29, 57 and thereafter every subsequent 63 days until discontinuation from study.
BIOLOGICAL	IMU-201 (administered as PD1-Vaxx) - Regimen 3	IMU-201 consists of APi2568 (lyophilized IMU-201) dissolved in WFI and emulsified with the adjuvant (Montanide ISA 720 VG) to produce PD1-Vaxx. IMU-201 will be administered as PD1-Vaxx intramuscularly into the deltoid region of the upper arm on Days 1, 15, 29, 57 and thereafter every 56 or 63 days until discontinuation from study.
DRUG	Atezolizumab	Atezolizumab will be administered every 2 weeks (Q2W) starting Day 15 until discontinuation from study.
DRUG	Standard of care chemotherapy	Chemotherapy to be administered according to the prescribing information.

Timeline

Start date: 2020-11-30
Primary completion: 2024-10-08
Completion: 2024-11-07
First posted: 2020-06-16
Last updated: 2026-03-25

Locations

6 sites across 2 countries: United States, Australia

Regulatory

FDA-regulated drug study

Source: ClinicalTrials.gov record NCT04432207. Inclusion in this directory is not an endorsement.