PD1-Vaxx Immunotherapy for Non-Small Cell Lung Cancer
Recruiting in Palo Alto (17 mi)
+5 other locations
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 1
Waitlist Available
Sponsor: Imugene Limited
No Placebo Group
Breakthrough Therapy
Trial Summary
What is the purpose of this trial?
This trial tests IMU-201 (PD1-Vaxx), a new treatment for adults with Non-Small Cell Lung Cancer. It aims to help the immune system create antibodies to fight cancer cells more effectively and safely than current treatments.
Research Team
Eligibility Criteria
Adults over 18 with advanced non-small cell lung cancer (NSCLC) who have either not been treated or have progressed after treatment with PD-1/PD-L1 inhibitors. They should be in relatively good health, with a life expectancy of at least 12 weeks and able to perform daily activities with little assistance (Zubrod/ECOG score 0-1). Patients must not have received certain treatments recently, have active infections requiring IV antibiotics, known HIV/Hepatitis B/C infection, uncontrolled other cancers or brain metastases needing steroids.Inclusion Criteria
I have not received IMU-201, atezolizumab, or chemotherapy before.
I am fully active and can carry on all my pre-disease activities without restriction.
My blood, liver, and kidney functions are all within normal ranges.
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Exclusion Criteria
My NSCLC has specific mutations (EGFR, ALK, BRAF, or ROS1) and I haven't had targeted treatments for these.
I haven't taken part in any drug trials or received experimental treatments in the last 3 weeks.
I have not had major surgery in the last 4 weeks or minor surgery in the last week.
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Treatment Details
Interventions
- IMU-201 (PD1-Vaxx) (Cancer Vaccine)
Trial OverviewThe trial is testing IMU-201 (PD1-Vaxx), an immunotherapy for NSCLC. It's given alone or combined with the drug Atezolizumab and/or standard chemotherapy. The study has different parts: dose escalation to find safe amounts and expansion where more patients receive these doses. Participants are grouped based on previous treatments and their tumor's PD-L1 protein levels.
Participant Groups
13Treatment groups
Experimental Treatment
Group I: Dose Expansion MonotherapyExperimental Treatment1 Intervention
mOBD (TBD) dose IMU-201 as a 0.5 mL PD1-Vaxx injection Progressed on/after ICI, TPS/TC ≥50% or IC ≥10%
Group II: Dose Expansion Arm 3: Combination with atezolizumab and chemotherapyExperimental Treatment3 Interventions
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
Group III: Dose Expansion Arm 2: Combination with atezolizumabExperimental Treatment2 Interventions
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%
Group IV: Dose Expansion Arm 1: Combination with atezolizumabExperimental Treatment2 Interventions
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%
Group V: Dose Escalation: Monotherapy Cohort 3Experimental Treatment1 Intervention
100 μg/dose IMU-201 as a 0.5 mL PD1-Vaxx injection Progressed on/after ICI, TPS/TC ≥50% or IC ≥10%
Group VI: Dose Escalation: Monotherapy Cohort 2Experimental Treatment1 Intervention
50 μg/dose IMU-201 as a 0.5 mL PD1-Vaxx injection Progressed on/after ICI, TPS/TC ≥50% or IC ≥10%
Group VII: Dose Escalation: Monotherapy Cohort 1Experimental Treatment1 Intervention
10 μg/dose IMU-201 as a 0.5 mL PD1-Vaxx injection Progressed on/after ICI, TPS/TC ≥50% or IC ≥10%
Group VIII: Dose Escalation Arm 2: Combination with atezolizumab and chemotherapy Cohort 3Experimental Treatment3 Interventions
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
Group IX: Dose Escalation Arm 2: Combination with atezolizumab and chemotherapy Cohort 2Experimental Treatment3 Interventions
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
Group X: Dose Escalation Arm 2: Combination with atezolizumab and chemotherapy Cohort 1Experimental Treatment3 Interventions
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
Group XI: Dose Escalation Arm 1: Combination with atezolizumab Cohort 3Experimental Treatment2 Interventions
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%
Group XII: Dose Escalation Arm 1: Combination with atezolizumab Cohort 2Experimental Treatment2 Interventions
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%
Group XIII: Dose Escalation Arm 1: Combination with atezolizumab Cohort 1Experimental Treatment2 Interventions
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%
Find a Clinic Near You
Who Is Running the Clinical Trial?
Imugene Limited
Lead Sponsor
Trials
7
Recruited
340+