A Study of IMU-201 (PD1-Vaxx), a B-Cell Immunotherapy, in Adults With Non-Small Cell Lung Cancer (NCT04432207) | Clinical Trial Compass
TerminatedPhase 1
A Study of IMU-201 (PD1-Vaxx), a B-Cell Immunotherapy, in Adults With Non-Small Cell Lung Cancer
Stopped: Portfolio prioritization
United States, Australia24 participantsStarted 2020-11-30
Plain-language 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).
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. 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, patients naïve to prior treatment
Exclusion criteria
✕. 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;
What they're measuring
1
Safety and tolerability of IMU-201 graded per terminology criteria for adverse events (CTCAE) version 5.00 (Dose Escalation)
Timeframe: Baseline to Day 29
2
Identify Optimal Biological Dose (OBD) with safety/tolerability graded per terminology criteria for adverse events (CTCAE) version 5.00 and Immuogenicity (Dose Escalation).
Timeframe: Baseline to Day 43
3
Overall response rate (ORR) (Dose Expansion)
Timeframe: Baseline to documented progressive disease (Approximately 15 months)
✕. 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);