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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)
1 other identifier
interventional
24
2 countries
6
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, in Adults with Non-Small Cell Lung Cancer (IMPrinter).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
Started Nov 2020
Longer than P75 for phase_1
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 10, 2020
CompletedFirst Posted
Study publicly available on registry
June 16, 2020
CompletedStudy Start
First participant enrolled
November 30, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 8, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
November 7, 2024
CompletedMarch 25, 2026
March 1, 2026
3.9 years
May 10, 2020
March 22, 2026
Conditions
Outcome Measures
Primary Outcomes (3)
Safety and tolerability of IMU-201 graded per terminology criteria for adverse events (CTCAE) version 5.00 (Dose Escalation)
Safety and Tolerability Measures include: Frequency of adverse events (AEs) graded per terminology criteria for adverse events (CTCAE) version 5.00.
Baseline to Day 29
Identify Optimal Biological Dose (OBD) with safety/tolerability graded per terminology criteria for adverse events (CTCAE) version 5.00 and Immuogenicity (Dose Escalation).
Safety and Tolerability Measures: Adverse events (AEs); dose-limiting toxicities (DLTs) graded per terminology criteria for adverse events (CTCAE) version 5.00. Immunogenicity data for IMU-201 includes PD-1 specific antibody (IgG) titers.
Baseline to Day 43
Overall response rate (ORR) (Dose Expansion)
Efficacy of IMU-201 will be evaluated by overall response rate at OBD of IMU-201 measured as the proportion of participants with a best overall response of complete or partial response.
Baseline to documented progressive disease (Approximately 15 months)
Secondary Outcomes (4)
Overall response rate (ORR) (Dose Escalation)
Baseline to documented progressive disease (Approximately 15 Months)
Progression free survival (PFS) (Dose Escalation/Expansion)
Baseline to documented progressive disease or death due to any cause (Approximately 15 Months)
Overall survival (OS) (Dose Escalation/Expansion)
Baseline to death from any cause (Approximately 15 Months)
Duration of response (DOR) (Dose Escalation/Expansion)
From date of earliest CR or PR until the date of first documented progression or death from any cause (Approximately 15 Months)
Other Outcomes (2)
Exploratory Outcome: Humoral immunogenicity of IMU-201 (Dose Escalation/Expansion)
Baseline to documented progressive disease (Approximately 15 Months)
Exploratory Outcome: Cellular immunogenicity of IMU-201 (Dose Escalation/Expansion)
Baseline to documented progressive disease (Approximately 15 Months)
Study Arms (13)
Dose Escalation: Monotherapy Cohort 1
EXPERIMENTAL10 μg/dose IMU-201 as a 0.5 mL PD1-Vaxx injection Progressed on/after ICI, TPS/TC ≥50% or IC ≥10%
Dose Escalation: Monotherapy Cohort 2
EXPERIMENTAL50 μg/dose IMU-201 as a 0.5 mL PD1-Vaxx injection Progressed on/after ICI, TPS/TC ≥50% or IC ≥10%
Dose Escalation: Monotherapy Cohort 3
EXPERIMENTAL100 μg/dose IMU-201 as a 0.5 mL PD1-Vaxx injection Progressed on/after ICI, TPS/TC ≥50% or IC ≥10%
Dose Expansion Monotherapy
EXPERIMENTALmOBD (TBD) dose IMU-201 as a 0.5 mL PD1-Vaxx injection Progressed on/after ICI, TPS/TC ≥50% or IC ≥10%
Dose Escalation Arm 1: Combination with atezolizumab Cohort 1
EXPERIMENTAL10 μg/dose IMU-201 as a 0.5 mL PD1-Vaxx injection with atezolizumab 840 mg Naïve to ICI or Progressed on/after ICI, TPS/TC ≥50% or IC ≥10%
Dose Escalation Arm 1: Combination with atezolizumab Cohort 2
EXPERIMENTAL50 μg/dose IMU-201 as a 0.5 mL PD1-Vaxx injection with atezolizumab 840 mg Naïve to ICI or Progressed on/after ICI, TPS/TC ≥50% or IC ≥10%
Dose Escalation Arm 1: Combination with atezolizumab Cohort 3
EXPERIMENTALCohort 3: 100 μg/dose IMU-201 as a 0.5 mL PD1-Vaxx injection with atezolizumab 840 mg Naïve to ICI or Progressed on/after ICI, TPS/TC ≥50% or IC ≥10%
Dose Escalation Arm 2: Combination with atezolizumab and chemotherapy Cohort 1
EXPERIMENTAL10 μg/dose IMU-201 as a 0.5 mL PD1-Vaxx injection with atezolizumab 840 mg and SOC chemotherapy Naïve to ICI, Any PD-L1 Level
Dose Escalation Arm 2: Combination with atezolizumab and chemotherapy Cohort 2
EXPERIMENTAL50 μg/dose IMU-201 as a 0.5 mL PD1-Vaxx injection with atezolizumab 840 mg and SOC chemotherapy Naïve to ICI, Any PD-L1 Level
Dose Escalation Arm 2: Combination with atezolizumab and chemotherapy Cohort 3
EXPERIMENTAL100 μg/dose IMU-201 as a 0.5 mL PD1-Vaxx injection with atezolizumab 840 mg and SOC chemotherapy Naïve to ICI, Any PD-L1 Level
Dose Expansion Arm 1: Combination with atezolizumab
EXPERIMENTALcOBD (TBD) dose IMU-201 as a 0.5 mL PD1-Vaxx injection with atezolizumab 840 mg Progressed on/after ICI, TPS/TC ≥50% or IC ≥10%
Dose Expansion Arm 2: Combination with atezolizumab
EXPERIMENTALcOBD (TBD) dose IMU-201 as a 0.5 mL PD1-Vaxx injection with atezolizumab 840 mg Naïve to ICI, TPS/TC ≥50% or IC ≥10%
Dose Expansion Arm 3: Combination with atezolizumab and chemotherapy
EXPERIMENTALcOBD (TBD) dose IMU-201 as a 05 mL PD1-Vaxx injection with atezolizumab 840 mg and SOC chemotherapy Naïve to ICI, Any PD-L1 Level
Interventions
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.
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.
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.
Atezolizumab will be administered every 2 weeks (Q2W) starting Day 15 until discontinuation from study.
Chemotherapy to be administered according to the prescribing information.
Eligibility Criteria
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%
- +6 more criteria
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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Imugene Limitedlead
Study Sites (6)
Mayo Clinic
Phoenix, Arizona, 85054, United States
Hackensack University Medical Center
Hackensack, New Jersey, 07601, United States
Ohio State University Medical Center
Columbus, Ohio, 43210, United States
Chris O'Brien Lifehouse
Camperdown, New South Wales, 2050, Australia
Macquarie University
Macquarie, New South Wales, 2109, Australia
Cabrini Malvern Hospital
Melbourne, Victoria, 3000, Australia
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 10, 2020
First Posted
June 16, 2020
Study Start
November 30, 2020
Primary Completion
October 8, 2024
Study Completion
November 7, 2024
Last Updated
March 25, 2026
Record last verified: 2026-03