Trial Review

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04432207


Additional trial details provided through ANZCTR are available at the end of this record.


Registration number
NCT04432207
Ethics application status
Date submitted
10/05/2020
Date registered
16/06/2020
Date last updated
7/11/2024

Titles & IDs
Public title
A Study of IMU-201 (PD1-Vaxx), a B-Cell Immunotherapy, in Adults with Non-Small Cell Lung Cancer
Scientific title
An Open Label, Multi-Center, Dose Escalation/Expansion, Phase 1/1b Study of IMU-201, a B-Cell Immunotherapy As Monotherapy or in Combination with Atezolizumab with or Without Chemotherapy, in Adults with Non- Small Cell Lung Cancer (IMPrinter)
Secondary ID [1] 0 0
IMU.201.101
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Non Small Cell Lung Cancer 0 0
Non Small Cell Lung Cancer Stage IIIB 0 0
Non-small Cell Lung Cancer Stage IV 0 0
Squamous Non-small-cell Lung Cancer 0 0
Large Cell Carcinoma Lung 0 0
Adenocarcinoma Lung 0 0
Condition category
Condition code
Cancer 0 0 0 0
Lung - Mesothelioma
Cancer 0 0 0 0
Lung - Non small cell
Cancer 0 0 0 0
Lung - Small cell
Cancer 0 0 0 0
Other cancer types

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Other - IMU-201 (administered as PD1-Vaxx) - Regimen 1
Treatment: Other - IMU-201 (administered as PD1-Vaxx) - Regimen 2
Treatment: Other - IMU-201 (administered as PD1-Vaxx) - Regimen 3
Treatment: Drugs - Atezolizumab
Treatment: Drugs - Standard of care chemotherapy

Experimental: Dose Escalation: Monotherapy Cohort 1 - 10 µg/dose IMU-201 as a 0.5 mL PD1-Vaxx injection Progressed on/after ICI, TPS/TC =50% or IC =10%

Experimental: Dose Escalation: Monotherapy Cohort 2 - 50 µg/dose IMU-201 as a 0.5 mL PD1-Vaxx injection Progressed on/after ICI, TPS/TC =50% or IC =10%

Experimental: Dose Escalation: Monotherapy Cohort 3 - 100 µg/dose IMU-201 as a 0.5 mL PD1-Vaxx injection Progressed on/after ICI, TPS/TC =50% or IC =10%

Experimental: Dose Expansion Monotherapy - mOBD (TBD) dose IMU-201 as a 0.5 mL PD1-Vaxx injection Progressed on/after ICI, TPS/TC =50% or IC =10%

Experimental: Dose Escalation Arm 1: Combination with atezolizumab Cohort 1 - 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%

Experimental: Dose Escalation Arm 1: Combination with atezolizumab Cohort 2 - 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%

Experimental: Dose Escalation Arm 1: Combination with atezolizumab Cohort 3 - 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%

Experimental: Dose Escalation Arm 2: Combination with atezolizumab and chemotherapy Cohort 1 - 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

Experimental: Dose Escalation Arm 2: Combination with atezolizumab and chemotherapy Cohort 2 - 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

Experimental: Dose Escalation Arm 2: Combination with atezolizumab and chemotherapy Cohort 3 - 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

Experimental: Dose Expansion Arm 1: Combination with atezolizumab - 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%

Experimental: Dose Expansion Arm 2: Combination with atezolizumab - 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%

Experimental: Dose Expansion Arm 3: Combination with atezolizumab and chemotherapy - 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


Treatment: Other: IMU-201 (administered as PD1-Vaxx) - Regimen 1
IMU-201 consists of APi2568 (lyophilized IMU-201) dissolved in WFI and emulsified with the adjuvant (Montanide ISA 720 VG) to produce PD1-Vaxx. IMU-201 will be administered as PD1-Vaxx intramuscularly into the deltoid region of the upper arm on Days 1, 15, 29, 64 and thereafter every 63 days until discontinuation from study.

Treatment: Other: IMU-201 (administered as PD1-Vaxx) - Regimen 2
IMU-201 consists of APi2568 (lyophilized IMU-201) dissolved in WFI and emulsified with the adjuvant (Montanide ISA 720 VG) to produce PD1-Vaxx. IMU-201 will be administered as PD1-Vaxx intramuscularly into the deltoid region of the upper arm on Days 1, 15, 29, 57 and thereafter every subsequent 63 days until discontinuation from study.

Treatment: Other: IMU-201 (administered as PD1-Vaxx) - Regimen 3
IMU-201 consists of APi2568 (lyophilized IMU-201) dissolved in WFI and emulsified with the adjuvant (Montanide ISA 720 VG) to produce PD1-Vaxx. IMU-201 will be administered as PD1-Vaxx intramuscularly into the deltoid region of the upper arm on Days 1, 15, 29, 57 and thereafter every 56 or 63 days until discontinuation from study.

Treatment: Drugs: Atezolizumab
Atezolizumab will be administered every 2 weeks (Q2W) starting Day 15 until discontinuation from study.

Treatment: Drugs: Standard of care chemotherapy
Chemotherapy to be administered according to the prescribing information.
Intervention code [1] 0 0
Treatment: Other
Intervention code [2] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Safety and tolerability of IMU-201 graded per terminology criteria for adverse events (CTCAE) version 5.00 (Dose Escalation)
Timepoint [1] 0 0
Baseline to Day 29
Primary outcome [2] 0 0
Identify Optimal Biological Dose (OBD) with safety/tolerability graded per terminology criteria for adverse events (CTCAE) version 5.00 and Immuogenicity (Dose Escalation).
Timepoint [2] 0 0
Baseline to Day 43
Primary outcome [3] 0 0
Overall response rate (ORR) (Dose Expansion)
Timepoint [3] 0 0
Baseline to documented progressive disease (Approximately 15 months)
Secondary outcome [1] 0 0
Overall response rate (ORR) (Dose Escalation)
Timepoint [1] 0 0
Baseline to documented progressive disease (Approximately 15 Months)
Secondary outcome [2] 0 0
Progression free survival (PFS) (Dose Escalation/Expansion)
Timepoint [2] 0 0
Baseline to documented progressive disease or death due to any cause (Approximately 15 Months)
Secondary outcome [3] 0 0
Overall survival (OS) (Dose Escalation/Expansion)
Timepoint [3] 0 0
Baseline to death from any cause (Approximately 15 Months)
Secondary outcome [4] 0 0
Duration of response (DOR) (Dose Escalation/Expansion)
Timepoint [4] 0 0
From date of earliest CR or PR until the date of first documented progression or death from any cause (Approximately 15 Months)

Eligibility
Key inclusion criteria
1. Age = 18 years with histologically confirmed non-small-cell lung cancer (NSCLC) tumor stage IIIb not eligible for definitive treatment or stage IV
2. Prior treatment criterion for Monotherapy dose escalation and expansion: progressed on/after prior PD-1/PD-L1 containing regimen
3. Prior treatment criteria for Combination dose escalation arms:

1. IMU-201 + atezolizumab, patients naïve to prior treatment or progressed on/after prior PD-1/PD-L1 containing regimen
2. IMU-201 + atezolizumab + chemotherapy, patient naïve to prior treatment naive
4. Prior treatment criteria for Combination dose expansion arms:

1. IMU-201 + atezolizumab, progressed on/after prior PD-1/PD-L1 containing regimen
2. IMU-201 + atezolizumab, patients naïve to prior treatment
3. IMU-201 + atezolizumab + chemotherapy, patients naïve to prior treatment
5. PD-L1 expression criteria (testing by 22C3, SP142, or SP263) for Monotherapy dose escalation and expansion: TPS/TC = 50% or IC = 10%. Patients with PD-L1 TPS/TC<50% or IC<10% expression may be included with agreement of Sponsor
6. PD-L1 expression criteria for Combination dose escalation arms:

1. IMU-201 + atezolizumab, TPS/TC = 50% or IC = 10%
2. IMU-201 + atezolizumab + chemotherapy, independent of PD-L1 expression
7. PD-L1 expression criteria for Combination dose expansion arms:

1. IMU-201 + atezolizumab, TPS/TC = 50% or IC = 10%
2. IMU-201 + atezolizumab, TPS/TC = 50% or IC = 10%
3. IMU-201 + atezolizumab + chemotherapy, independent of PD-L1 expression
8. Life expectancy of at least 12 weeks in the opinion of the Investigator
9. Zubrod/ECOG score performance status 0-1
10. At least one measurable lesion as defined by RECIST 1.1 criteria.
11. Adequate hematologic, liver, and renal function
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Prior therapy for advanced NSCLC within 3 weeks prior to Day 1;
2. 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.;
3. Any previous grade 3 or higher toxicity to a PD-1 inhibitor or PD-L1 inhibitor;
4. Has a history of (non-infectious) pneumonitis/interstitial lung disease that required treatment with immunosuppressive agents or has current pneumonitis/interstitial lung disease;
5. Known brain metastases requiring steroid treatment, or signs and symptoms indicating suspected brain metastases;
6. Current or previous history of auto-immune disease;
7. 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);
8. Prior organ transplant;
9. Concurrent active malignancy except for adequately controlled limited basal cell carcinoma of the skin;
10. History of uncontrolled seizures, central nervous disorders, or psychiatric disability judged by the Investigator to be clinically significant and precluding informed consent, participation in the study, or adversely affecting compliance to study drugs;
11. Active infection requiring intravenous antibiotics;
12. Known history of human immunodeficiency virus (HIV) infection or Hepatitis B (defined as Hepatitis B surface antigen [HBsAg] reactive) or known active Hepatitis C virus (defined as HCV Ribonucleic acid (RNA) [qualitative] is detected) infection;
13. Major surgery within 4 weeks prior to study entry. Minor surgery (excluding diagnostic biopsy) within 1 week prior to study entry;
14. Any vaccination within 2 weeks prior to starting study treatment;
15. Treatment with any investigational drug or participation in another investigational study within 3 weeks prior to first IMU-201 dose.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
30/11/2020
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/05/2025
Actual
Sample size
Target
Accrual to date
Final
24
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Recruitment hospital [1] 0 0
Chris O'Brien Lifehouse - Camperdown
Recruitment hospital [2] 0 0
Macquarie University - Macquarie
Recruitment hospital [3] 0 0
Cabrini Malvern Hospital - Melbourne
Recruitment postcode(s) [1] 0 0
2050 - Camperdown
Recruitment postcode(s) [2] 0 0
2109 - Macquarie
Recruitment postcode(s) [3] 0 0
3000 - Melbourne
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
New Jersey
Country [3] 0 0
United States of America
State/province [3] 0 0
Ohio

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Imugene Limited
Address
Country

Ethics approval
Ethics application status

Summary
Brief 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).
Trial website
https://clinicaltrials.gov/study/NCT04432207
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT04432207

Additional trial details provided through ANZCTR
Accrual to date
Recruiting in Australia
Recruitment state(s)
NSW,VIC
Funding & Sponsors
Primary sponsor
Commercial sector/Industry
Primary sponsor name
Imugene Limited
Primary sponsor address
Primary sponsor country
Australia
Ethics approval
Ethics application status
Approved
 
Public notes

Contacts
Principal investigator
Title 177 0
Name 177 0
Address 177 0
Country 177 0
Phone 177 0
Fax 177 0
Email 177 0
Contact person for public queries
Title 178 0
Name 178 0
Imugene Limited
Address 178 0
Country 178 0
Australia
Phone 178 0
Fax 178 0
Email 178 0
[email protected]
Contact person for scientific queries
Title 179 0
Name 179 0
Address 179 0
Country 179 0
Phone 179 0
Fax 179 0
Email 179 0