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

Stopped early · Phase 1

Conditions studied: 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

In brief

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).

Key facts

Study ID

NCT04432207

Run by

Imugene Limited

People needed

24

Starts

2020-11-30

Expected to finish

2024-11-07

Last updated by the study team

2026-03-25

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age ≥ 18 years with histologically confirmed non-small-cell lung cancer (NSCLC) tumor stage IIIb not eligible for definitive treatment or stage IV
• Prior treatment criterion for Monotherapy dose escalation and expansion: progressed on/after prior PD-1/PD-L1 containing regimen
• Prior treatment criteria for Combination dose escalation arms:
• IMU-201 + atezolizumab, patients naïve to prior treatment or progressed on/after prior PD-1/PD-L1 containing regimen
• IMU-201 + atezolizumab + chemotherapy, patient naïve to prior treatment naive
• Prior treatment criteria for Combination dose expansion arms:
• IMU-201 + atezolizumab, progressed on/after prior PD-1/PD-L1 containing regimen
• IMU-201 + atezolizumab, patients naïve to prior treatment
• IMU-201 + atezolizumab + chemotherapy, patients naïve to prior treatment
• PD-L1 expression criteria (testing by 22C3, SP142, or SP263) for Monotherapy dose escalation and expansion: TPS/TC ≥ 50% or IC ≥ 10%. Patients with PD-L1 TPS/TC<50% or IC<10% expression may be included with agreement of Sponsor
• PD-L1 expression criteria for Combination dose escalation arms:
• IMU-201 + atezolizumab, TPS/TC ≥ 50% or IC ≥ 10%
• IMU-201 + atezolizumab + chemotherapy, independent of PD-L1 expression
• PD-L1 expression criteria for Combination dose expansion arms:
• IMU-201 + atezolizumab, TPS/TC ≥ 50% or IC ≥ 10%
• IMU-201 + atezolizumab, TPS/TC ≥ 50% or IC ≥ 10%
• IMU-201 + atezolizumab + chemotherapy, independent of PD-L1 expression
• Life expectancy of at least 12 weeks in the opinion of the Investigator
• Zubrod/ECOG score performance status 0-1
• At least one measurable lesion as defined by RECIST 1.1 criteria.
• Adequate hematologic, liver, and renal function

You may not qualify if…

• Prior therapy for advanced NSCLC within 3 weeks prior to Day 1;
• Continuous systemic treatment with either corticosteroids (> 10 mg daily prednisone equivalents) or other immunosuppressive medications within 2 weeks prior to first dose of study treatment.;
• Any previous grade 3 or higher toxicity to a PD-1 inhibitor or PD-L1 inhibitor;
• Has a history of (non-infectious) pneumonitis/interstitial lung disease that required treatment with immunosuppressive agents or has current pneumonitis/interstitial lung disease;
• Known brain metastases requiring steroid treatment, or signs and symptoms indicating suspected brain metastases;
• Current or previous history of auto-immune disease;
• NSCLC expressing epidermal growth factor receptor (EGFR), anaplastic lymphoma kinase (ALK), B-Raf proto-oncogene (BRAF) or ROS proto-oncogene 1 (ROS1) mutations who have not received appropriate therapies targeting these mutations and progress (if treatments are not available, patients who have NOT received appropriate therapies may be enrolled);
• Prior organ transplant;
• Concurrent active malignancy except for adequately controlled limited basal cell carcinoma of the skin;
• History of uncontrolled seizures, central nervous disorders, or psychiatric disability judged by the Investigator to be clinically significant and precluding informed consent, participation in the study, or adversely affecting compliance to study drugs;
• Active infection requiring intravenous antibiotics;
• Known history of human immunodeficiency virus (HIV) infection or Hepatitis B (defined as Hepatitis B surface antigen [HBsAg] reactive) or known active Hepatitis C virus (defined as HCV Ribonucleic acid (RNA) [qualitative] is detected) infection;
• Major surgery within 4 weeks prior to study entry. Minor surgery (excluding diagnostic biopsy) within 1 week prior to study entry;
• Any vaccination within 2 weeks prior to starting study treatment;
• Treatment with any investigational drug or participation in another investigational study within 3 weeks prior to first IMU-201 dose.

Where it is running

• Mayo Clinic — Phoenix, Arizona, United States
• Hackensack University Medical Center — Hackensack, New Jersey, United States
• Ohio State University Medical Center — Columbus, Ohio, United States
• Chris O'Brien Lifehouse — Camperdown, New South Wales, Australia
• Macquarie University — Macquarie, New South Wales, Australia
• Cabrini Malvern Hospital — Melbourne, Victoria, Australia

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.