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Closed (no longer recruiting)Last updated: 6 February 2024

This phase I trial is evaluating the safety and tolerability of a new type of immunotherapy, given alone or with standard of care treatment, in patients with PD-L1 non-small cell lung cancerAn Open Label, Multi-Center, Dose Escalation/Expansion, Phase 1 Study of IMU-201 (PD1-Vaxx), a B-Cell Immunotherapy, in Adults With Non-Small Cell Lung Cancer

Clinical summary

Summary

This is a dose escalation and expansion trial. Dose escalation will occur across three monotherapy cohorts (10 μg/dose, 50 μg/dose and 100μg/dose IMU-201 as a 0.5 mL PD1-Vaxx injection)and one combination cohort, in which patients will receive standard of care treatment for non-small cell lung cancer in combination with MU-201 at a starting dose below the monotherapy optimal biological dose. Dose expansion will commence once an optimal biological dose of MU-201 is determined in the combination cohort of the dose escalation phase. Patients enrolled in the expansion cohort will receive IMU-201 in combination with standard of care treatment for non-small cell lung cancer.

Conditions

This trial is treating patients with non-small cell lung cancer

Cancer

Lung Cancers Lung cancer

Age

People18+

Phase

I

More information

Trial Identifiers

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Trial sponsor

Imugene Limited

Scientific Title

An Open Label, Multi-Center, Dose Escalation/Expansion, Phase 1 Study of IMU-201 (PD1-Vaxx), a B-Cell Immunotherapy, in Adults With Non-Small Cell Lung Cancer

Eligibility

Inclusion

  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

  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.

Exclusion

  • You have been diagnosed with a prior or secondary type of cancer.
  • You have certain types of non-cancer medical conditions.
  • You have had certain treatments, surgical procedures or drugs.
  • You have previously been treated (or are currently being treated) on a clinical trial.
Message

Clinical trials have complex eligibility criteria.

Ask your doctor if this trial could be right for you.

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