Status:
ACTIVE_NOT_RECRUITING
A Study of IMU-201 (PD1-Vaxx), a B-Cell Immunotherapy, in Adults with Non-Small Cell Lung Cancer
Lead Sponsor:
Imugene Limited
Conditions:
Non Small Cell Lung Cancer
Non Small Cell Lung Cancer Stage IIIB
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief 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, ...
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 28...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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.
Key Trial Info
Start Date :
November 30 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2025
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT04432207
Start Date
November 30 2020
End Date
May 1 2025
Last Update
November 7 2024
Active Locations (6)
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1
Mayo Clinic
Phoenix, Arizona, United States, 85054
2
Hackensack University Medical Center
Hackensack, New Jersey, United States, 07601
3
Ohio State University Medical Center
Columbus, Ohio, United States, 43210
4
Chris O'Brien Lifehouse
Camperdown, New South Wales, Australia, 2050