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 a new treatment called IMU-201 (PD1-Vaxx) for individuals with non-small cell lung cancer. Researchers aim to assess the safety and effectiveness of this immunotherapy, both alone and in combination with other treatments like atezolizumab and chemotherapy. The trial seeks participants whose lung cancer has progressed after certain treatments or who have not yet tried these treatments. Those with non-small cell lung cancer, whether experienced with immunotherapy or new to it, may find this trial suitable. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new treatment.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that IMU-201 (PD1-Vaxx) is generally well-tolerated. It is designed to help the body’s immune system fight cancer by creating antibodies that target PD-L1, a protein found on cancer cells. The study aims to find the right dose that balances effectiveness with safety.

In previous trials, patients who used IMU-201 alone did not experience any unexpected serious side effects. Common side effects included mild reactions at the injection site and flu-like symptoms, typical for treatments that boost the immune system.

When combined with atezolizumab, a medicine already approved for some types of lung cancer, no new safety concerns arose beyond those known for atezolizumab itself.

Adding chemotherapy to IMU-201 and atezolizumab has shown similar safety profiles, with side effects consistent with those of each treatment alone. Chemotherapy can cause tiredness, nausea, and hair loss, which are expected.

IMU-201 is in the early stages of testing, so information is still being gathered. However, available data suggest it is reasonably safe for people who choose to join a trial. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about PD1-Vaxx for non-small cell lung cancer because it offers a fresh approach to immunotherapy. Unlike standard treatments like chemotherapy or PD-1 inhibitors, PD1-Vaxx is a vaccine that stimulates the immune system to target cancer cells more effectively. This active immunotherapy approach aims to train the immune system to recognize and attack cancer cells, potentially offering a longer-lasting defense. Additionally, when combined with other treatments like atezolizumab and chemotherapy, it might enhance the effectiveness of existing therapies, providing a comprehensive strategy against the cancer.

What evidence suggests that this trial's treatments could be effective for non-small cell lung cancer?

Research has shown that IMU-201 (PD1-Vaxx) is designed to help the body produce antibodies against PD-1, a protein that some cancers use to evade the immune system. Early findings suggest that IMU-201 may be effective in patients with cancers exhibiting high levels of PD-L1, a related protein. Initial results showed no major serious side effects and some early signs of effectiveness. In this trial, some participants will receive IMU-201 as monotherapy, while others will receive it with atezolizumab, an existing cancer drug, to further enhance the immune response. Additionally, some trial arms will explore combining IMU-201 with both atezolizumab and chemotherapy, which might increase its effectiveness, although specific data on this combination is still under study. ^{1 2 3 4 6}

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+

Citations

1. jto.org jto.org/article/S1556-0864(22)00545-7/fulltext

P1.15-08 Phase 1: IMU-201 (PD1-Vaxx), a B-Cell ... IMU-201 (PD1-Vaxx) is being developed using an active immunization approach to treat cancers that overexpress PD-L1 by inducing the production of anti-PD-1 ...

2. ascopubs.org ascopubs.org/doi/10.1200/JCO.2022.40.16_suppl.e21134

IMPRINTER: An open label, multicenter, dose escalation/ ... The IMPRINTER study is an ongoing open-label dose escalation study of IMU-201 as monotherapy (Phase 1) or in combination with atezolizumab (Phase 1b)

3. clinicaltrials.gov clinicaltrials.gov/study/NCT04432207

NCT04432207 | A Study of IMU-201 (PD1-Vaxx), a B-Cell ... This phase 1/1b study is an open-label dose escalation/dose expansion study designed to assess the safety, tolerability, immunogenicity and efficacy of IMU-201 ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S1556086422005457#!

P1.15-08 Phase 1: IMU-201 (PD1-Vaxx), a B-Cell ... IMU-201 had no observed DLT and demonstrated preliminary signs of efficacy. The study will therefore move into Phase 1b with IMU-201 being assessed in ...

5. mycancergenome.org mycancergenome.org/content/clinical_trials/NCT04432207/

Clinical Trial: NCT04432207 This phase 1 study is designed to assess the safety, tolerability, and immunogenicity of IMU-201 (PD1-Vaxx) as monotherapy in patients with PD- ...

6. annalsofoncology.org annalsofoncology.org/article/S0923-7534(21)04198-3/fulltext

1367TiP IMPRINTER: An open label, multi-center, dose ... IMU-201 is being developed using an active immunization approach to treat cancers that overexpress programmed cell death ligand 1 (PD-L1)