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

NCT04432207 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2026-03-25

No results posted yet for this study

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).

Conditions

  • Non Small Cell Lung Cancer
  • Non Small Cell Lung Cancer Stage IIIB
  • Non-small Cell Lung Cancer Stage IV
  • Squamous Non-small-cell Lung Cancer
  • Large Cell Carcinoma Lung
  • Adenocarcinoma Lung

Interventions

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.

Sponsors & Collaborators

  • Imugene Limited

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-11-30
Primary Completion
2024-10-08
Completion
2024-11-07
FDA Drug
Yes

Countries

  • United States
  • Australia

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04432207 on ClinicalTrials.gov