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

What You Need to Know Before You Apply

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.

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+