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

Part of paid clinical trials in Phoenix, Arizona.

Sponsor
Imugene Limited
Study ID
NCT04432207
Phase
PHASE1
Status
Terminated

Conditions

  • Adenocarcinoma Lung
  • Large Cell Carcinoma Lung
  • 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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • IMU-201 (administered as PD1-Vaxx) - Regimen 1 — BIOLOGICAL
    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 (administered as PD1-Vaxx) - Regimen 2 — BIOLOGICAL
    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 (administered as PD1-Vaxx) - Regimen 3 — BIOLOGICAL
    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 — DRUG
    Atezolizumab will be administered every 2 weeks (Q2W) starting Day 15 until discontinuation from study.
  • Standard of care chemotherapy — DRUG
    Chemotherapy to be administered according to the prescribing information.

Study Details

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 Dates

Start date
Nov 30, 2020
Status verified
Mar 2026
Primary completion
Oct 8, 2024
Completion
Nov 7, 2024

Study Design

Enrollment
24 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • 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%
  • 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%
  • 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%
  • 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%
  • 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%
  • 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%
  • 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%
  • 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
  • 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
  • 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
  • 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%
  • 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%
  • 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

Primary Outcome Measure

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 ]

Locations (3)

FacilityCityStateZIPSite coordinators
Mayo ClinicPhoenixArizona85054-
Hackensack University Medical CenterHackensackNew Jersey07601-
Ohio State University Medical CenterColumbusOhio43210-

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