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

January 24, 2024 updated by: Imugene Limited

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)

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).

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

24

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Australia
    • New South Wales
      • Camperdown, New South Wales, Australia, 2050
        • Chris O'Brien Lifehouse
      • Macquarie, New South Wales, Australia, 2109
        • Macquarie University
    • Victoria
      • Melbourne, Victoria, Australia, 3000
        • Cabrini Malvern Hospital
  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85054
        • Mayo Clinic
    • New Jersey
      • Hackensack, New Jersey, United States, 07601
        • Hackensack University Medical Center
    • Ohio
      • Columbus, Ohio, United States, 43210
        • Ohio State University Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Age ≥ 18 years with histologically confirmed non-small-cell lung cancer (NSCLC) tumor stage IIIb not eligible for definitive treatment or stage IV
  2. Prior treatment criterion for Monotherapy dose escalation and expansion: progressed on/after prior PD-1/PD-L1 containing regimen

  3. Prior treatment criteria for Combination dose escalation arms:

    1. IMU-201 + atezolizumab, patients naïve to prior treatment or progressed on/after prior PD-1/PD-L1 containing regimen
    2. IMU-201 + atezolizumab + chemotherapy, patient naïve to prior treatment naive

  4. Prior treatment criteria for Combination dose expansion arms:

    1. IMU-201 + atezolizumab, progressed on/after prior PD-1/PD-L1 containing regimen
    2. IMU-201 + atezolizumab, patients naïve to prior treatment
    3. IMU-201 + atezolizumab + chemotherapy, patients naïve to prior treatment
  5. 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

  6. PD-L1 expression criteria for Combination dose escalation arms:

    1. IMU-201 + atezolizumab, TPS/TC ≥ 50% or IC ≥ 10%
    2. IMU-201 + atezolizumab + chemotherapy, independent of PD-L1 expression

  7. PD-L1 expression criteria for Combination dose expansion arms:

    1. IMU-201 + atezolizumab, TPS/TC ≥ 50% or IC ≥ 10%
    2. IMU-201 + atezolizumab, TPS/TC ≥ 50% or IC ≥ 10%
    3. IMU-201 + atezolizumab + chemotherapy, independent of PD-L1 expression
  8. Life expectancy of at least 12 weeks in the opinion of the Investigator
  9. Zubrod/ECOG score performance status 0-1
  10. At least one measurable lesion as defined by RECIST 1.1 criteria.
  11. Adequate hematologic, liver, and renal function

Exclusion Criteria:

  1. Prior therapy for advanced NSCLC within 3 weeks prior to Day 1;
  2. 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.;
  3. Any previous grade 3 or higher toxicity to a PD-1 inhibitor or PD-L1 inhibitor;
  4. Has a history of (non-infectious) pneumonitis/interstitial lung disease that required treatment with immunosuppressive agents or has current pneumonitis/interstitial lung disease;
  5. Known brain metastases requiring steroid treatment, or signs and symptoms indicating suspected brain metastases;
  6. Current or previous history of auto-immune disease;
  7. 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);
  8. Prior organ transplant;
  9. Concurrent active malignancy except for adequately controlled limited basal cell carcinoma of the skin;
  10. 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;
  11. Active infection requiring intravenous antibiotics;
  12. 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;
  13. Major surgery within 4 weeks prior to study entry. Minor surgery (excluding diagnostic biopsy) within 1 week prior to study entry;
  14. Any vaccination within 2 weeks prior to starting study treatment;
  15. Treatment with any investigational drug or participation in another investigational study within 3 weeks prior to first IMU-201 dose.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Dose Escalation: Monotherapy Cohort 1
10 μg/dose IMU-201 as a 0.5 mL PD1-Vaxx injection Progressed on/after ICI, TPS/TC ≥50% or IC ≥10%
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.
Other Names:
  • PD1-Vaxx
  • APi2568
Experimental: Dose Escalation: Monotherapy Cohort 2
50 μg/dose IMU-201 as a 0.5 mL PD1-Vaxx injection Progressed on/after ICI, TPS/TC ≥50% or IC ≥10%
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.
Other Names:
  • PD1-Vaxx
  • APi2568
Experimental: Dose Escalation: Monotherapy Cohort 3
100 μg/dose IMU-201 as a 0.5 mL PD1-Vaxx injection Progressed on/after ICI, TPS/TC ≥50% or IC ≥10%
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.
Other Names:
  • PD1-Vaxx
  • APi2568
Experimental: Dose Expansion Monotherapy
mOBD (TBD) dose IMU-201 as a 0.5 mL PD1-Vaxx injection Progressed on/after ICI, TPS/TC ≥50% or IC ≥10%
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.
Other Names:
  • PD1-Vaxx
  • APi2568
Experimental: Dose Escalation Arm 1: Combination with atezolizumab Cohort 1
10 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%
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.
Other Names:
  • PD1-Vaxx
  • APi2568
Drug: Atezolizumab
Atezolizumab will be administered every 2 weeks (Q2W) starting Day 15 until discontinuation from study.
Other Names:
  • TECENTRIQ
Experimental: Dose Escalation Arm 1: Combination with atezolizumab Cohort 2
50 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%
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.
Other Names:
  • PD1-Vaxx
  • APi2568
Drug: Atezolizumab
Atezolizumab will be administered every 2 weeks (Q2W) starting Day 15 until discontinuation from study.
Other Names:
  • TECENTRIQ
Experimental: Dose Escalation Arm 1: Combination with atezolizumab Cohort 3
Cohort 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%
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.
Other Names:
  • PD1-Vaxx
  • APi2568
Drug: Atezolizumab
Atezolizumab will be administered every 2 weeks (Q2W) starting Day 15 until discontinuation from study.
Other Names:
  • TECENTRIQ
Experimental: Dose Escalation Arm 2: Combination with atezolizumab and chemotherapy Cohort 1
10 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
Drug: Atezolizumab
Atezolizumab will be administered every 2 weeks (Q2W) starting Day 15 until discontinuation from study.
Other Names:
  • TECENTRIQ
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.
Other Names:
  • PD1-Vaxx
  • APi2568
Drug: Standard of care chemotherapy
Chemotherapy to be administered according to the prescribing information.
Experimental: Dose Escalation Arm 2: Combination with atezolizumab and chemotherapy Cohort 2
50 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
Drug: Atezolizumab
Atezolizumab will be administered every 2 weeks (Q2W) starting Day 15 until discontinuation from study.
Other Names:
  • TECENTRIQ
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.
Other Names:
  • PD1-Vaxx
  • APi2568
Drug: Standard of care chemotherapy
Chemotherapy to be administered according to the prescribing information.
Experimental: Dose Escalation Arm 2: Combination with atezolizumab and chemotherapy Cohort 3
100 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
Drug: Atezolizumab
Atezolizumab will be administered every 2 weeks (Q2W) starting Day 15 until discontinuation from study.
Other Names:
  • TECENTRIQ
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.
Other Names:
  • PD1-Vaxx
  • APi2568
Drug: Standard of care chemotherapy
Chemotherapy to be administered according to the prescribing information.
Experimental: Dose Expansion Arm 1: Combination with atezolizumab
cOBD (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%
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.
Other Names:
  • PD1-Vaxx
  • APi2568
Drug: Atezolizumab
Atezolizumab will be administered every 2 weeks (Q2W) starting Day 15 until discontinuation from study.
Other Names:
  • TECENTRIQ
Experimental: Dose Expansion Arm 2: Combination with atezolizumab
cOBD (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%
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.
Other Names:
  • PD1-Vaxx
  • APi2568
Drug: Atezolizumab
Atezolizumab will be administered every 2 weeks (Q2W) starting Day 15 until discontinuation from study.
Other Names:
  • TECENTRIQ
Experimental: Dose Expansion Arm 3: Combination with atezolizumab and chemotherapy
cOBD (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
Drug: Atezolizumab
Atezolizumab will be administered every 2 weeks (Q2W) starting Day 15 until discontinuation from study.
Other Names:
  • TECENTRIQ
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.
Other Names:
  • PD1-Vaxx
  • APi2568
Drug: Standard of care chemotherapy
Chemotherapy to be administered according to the prescribing information.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety and tolerability of IMU-201 graded per terminology criteria for adverse events (CTCAE) version 5.00 (Dose Escalation)
Time Frame: Baseline to Day 29
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).
Time Frame: Baseline to Day 43
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)
Time Frame: Baseline to documented progressive disease (Approximately 15 months)
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall response rate (ORR) (Dose Escalation)
Time Frame: Baseline to documented progressive disease (Approximately 15 Months)
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)
Progression free survival (PFS) (Dose Escalation/Expansion)
Time Frame: Baseline to documented progressive disease or death due to any cause (Approximately 15 Months)
Efficacy of IMU-201 will be evaluated by progression free survival at OBD of IMU-201.
Baseline to documented progressive disease or death due to any cause (Approximately 15 Months)
Overall survival (OS) (Dose Escalation/Expansion)
Time Frame: Baseline to death from any cause (Approximately 15 Months)
Efficacy of IMU-201 will be evaluated by overall survival at OBD of IMU-201.
Baseline to death from any cause (Approximately 15 Months)
Duration of response (DOR) (Dose Escalation/Expansion)
Time Frame: From date of earliest CR or PR until the date of first documented progression or death from any cause (Approximately 15 Months)
Efficacy of IMU-201 will be evaluated by duration of response at OBD of IMU-201.
From date of earliest CR or PR until the date of first documented progression or death from any cause (Approximately 15 Months)

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Exploratory Outcome: Humoral immunogenicity of IMU-201 (Dose Escalation/Expansion)
Time Frame: Baseline to documented progressive disease (Approximately 15 Months)
Humoral immunogenicity evaluated by PD-1 specific antibodies (IgG, IgM).
Baseline to documented progressive disease (Approximately 15 Months)
Exploratory Outcome: Cellular immunogenicity of IMU-201 (Dose Escalation/Expansion)
Time Frame: Baseline to documented progressive disease (Approximately 15 Months)
Cellular immunogenicity evaluated by vaccine-specific cytokine levels as well as analysis of regulatory and effector T and B cells.
Baseline to documented progressive disease (Approximately 15 Months)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Imugene Limited

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 30, 2020

Primary Completion (Estimated)

February 1, 2026

Study Completion (Estimated)

March 1, 2026

Study Registration Dates

First Submitted

May 10, 2020

First Submitted That Met QC Criteria

June 11, 2020

First Posted (Actual)

June 16, 2020

Study Record Updates

Last Update Posted (Actual)

January 25, 2024

Last Update Submitted That Met QC Criteria

January 24, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IMU.201.101

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Non Small Cell Lung Cancer

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Saudi Arabia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe