PD1-Vaxx Immunotherapy for Non-Small Cell Lung Cancer

Recruiting at 5 trial locations

Overseen By Yuni Kim

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Imugene Limited

Must not be taking: Corticosteroids, Immunosuppressives

Disqualifiers: Auto-immune disease, Brain metastases, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

24 Participants Needed

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.

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.

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.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dose Escalation

Phase 1 monotherapy dose-escalation of IMU-201 (PD1-Vaxx) to establish the optimal monotherapy biological dose (mBOD).

6-8 weeks

Multiple visits for dose administration and monitoring

Dose Expansion

Expansion of the dose cohort to enroll additional patients at the mBOD dose level.

8-12 weeks

Regular visits for treatment and monitoring

Combination Dose Escalation

Phase 1b combination dose-escalation of IMU-201 (PD1-Vaxx) with atezolizumab and with or without chemotherapy to establish the optimal combotherapy biological dose (cBOD).

6-8 weeks

Multiple visits for combination treatment and monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment

15 months

Periodic visits for monitoring response and survival

Treatment Details

Interventions

• IMU-201 (PD1-Vaxx)

Trial Overview The 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

Group I: Dose Expansion Monotherapy Experimental Treatment 1 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 chemotherapy Experimental Treatment 3 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 atezolizumab Experimental Treatment 2 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 atezolizumab Experimental Treatment 2 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 3 Experimental Treatment 1 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 2 Experimental Treatment 1 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 1 Experimental Treatment 1 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 3 Experimental Treatment 3 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 2 Experimental Treatment 3 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 1 Experimental Treatment 3 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 3 Experimental Treatment 2 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 2 Experimental Treatment 2 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 1 Experimental Treatment 2 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%

Who Is Running the Clinical Trial?

Imugene Limited

Lead Sponsor

Trials

7

Recruited

340+