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Trial details imported from ClinicalTrials.gov

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




Registration number
NCT04432207
Ethics application status
Date submitted
10/05/2020
Date registered
16/06/2020
Date last updated
28/09/2020

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 Study of IMU-201 (PD1-Vaxx), a B-Cell Immunotherapy, in Adults With Non-Small Cell Lung Cancer
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: Drugs - IMU-201 (administered as PD1-Vaxx)
Treatment: Drugs - Standard of care treatment for NSCLC

Experimental: Dose Escalation: Monotherapy Cohort 1 - 10 µg/dose IMU-201 as a 0.5 mL PD1-Vaxx injection

Experimental: Dose Escalation: Monotherapy Cohort 2 - 50 µg/dose IMU-201 as a 0.5 mL PD1-Vaxx injection

Experimental: Dose Escalation: Monotherapy Cohort 3 - 100 µg/dose IMU-201 as a 0.5 mL PD1-Vaxx injection

Experimental: Dose Escalation: Combination - In Part 1b combination dose escalation, participants receive MU-201 in combination with SOC treatment for NSCLC with the first dose cohort starting at one dose level below the monotherapy optimal biological dose (mOBD-1) established in part 1a monotherapy dose escalation.

Experimental: Dose Expansion: Combination - In Part 2 dose expansion, participants will receive IMU-201 in combination with SOC treatment for NSCLC at the combination optimal biological dose determined in Part 1b combination dose escalation.


Treatment: Drugs: IMU-201 (administered as PD1-Vaxx)
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, and 29, and then on Day 64 and every subsequent 63 days until discontinuation from study.

Treatment: Drugs: Standard of care treatment for NSCLC
Standard of care treatment/s administered according to institution standard practices and manufacturer's instructions.

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Safety and tolerability of IMU-201 as monotherapy graded per terminology criteria for adverse events (CTCAE) version 5.00 - Safety and Tolerability Measures include: Adverse events (AEs); dose-limiting toxicities (DLTs) graded per terminology criteria for adverse events (CTCAE) version 5.00.
Timepoint [1] 0 0
Baseline to Day 29
Primary outcome [2] 0 0
Safety and tolerability of IMU-201 in combination with standard of care graded per terminology criteria for adverse events (CTCAE) version 5.00 - Safety and Tolerability Measures include: Adverse events (AEs); dose-limiting toxicities (DLTs) graded per terminology criteria for adverse events (CTCAE) version 5.00.
Timepoint [2] 0 0
Baseline to Day 29
Primary outcome [3] 0 0
Identify Optimal Biological Dose (OBD) with safety/tolerability graded per terminology criteria for adverse events (CTCAE) version 5.00 and Immuogenicity. - Safety and Tolerability Measures: Adverse events (AEs); dose-limiting toxicities (DLTs) graded per terminology criteria for adverse events (CTCAE) version 5.00. Immunogenicity data for IMU-201 includes PD-1 specific antibody (IgG) titers.
Timepoint [3] 0 0
Baseline to Day 43
Secondary outcome [1] 0 0
Overall response rate (ORR) - Efficacy of IMU-201 as monotherapy and in combination with standard of care will be evaluated by overall response rate at OBD of IMU-201 measured as the proportion of participants with a best overall response of complete or partial response.
Timepoint [1] 0 0
Baseline to documented progressive disease (Approximately 15 Months)
Secondary outcome [2] 0 0
Progression free survival (PFS) - Efficacy of IMU-201 as monotherapy and in combination with standard of care will be evaluated by progression free survival at OBD of IMU-201.
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) - Efficacy of IMU-201 as monotherapy and in combination with standard of care will be evaluated by overall survival at OBD of IMU-201
Timepoint [3] 0 0
Baseline to death from any cause (Approximately 15 Months)

Eligibility
Key inclusion criteria
1. Informed of the investigational nature of this study and has given written informed
consent in accordance with institutional, local, and national guidelines;

2. Histologically confirmed non-small-cell lung cancer (NSCLC) tumor stage IIIb or IV (3
major types of NSCLC are acceptable including squamous, adenocarcinoma, and large cell
carcinoma);

3. Part 1a, monotherapy dose escalation: Progressed on ICI or an ICI and chemotherapy;
Part 1b and 2, combination dose escalation and expansion: No previous treatment with
an ICI;

4. Age of at least 18 years;

5. Life expectancy of at least 12 weeks in the opinion of the Investigator;

6. Tumor PD-L1 overexpression with Tumor Proportion Score (TPS) = 50%. Participants with
PD-L1 TPS = 1% expression may be included with agreement of Imugene Limited in Part 1a
only;

7. Zubrod/ECOG score performance status 0-1;

8. At least one measurable lesion as defined by RECIST 1.1 criteria. Patients with
non-measurable lesions may be included with agreement of Imugene Limited;

9. Adequate hematologic function: Absolute neutrophil count (ANC) > 1.5x109/L, platelet
count at > 100x109/L, and hemoglobin > 9 g/dL;

10. Adequate liver function evidenced by bilirubin at < 1.5x laboratory upper limit of
normal [ULN], and ALT and AST at < 3x laboratory ULN if no liver involvement or ALT
and AST at < 5x laboratory ULN with liver involvement;

11. Adequate renal function (creatinine at < 1.5x laboratory ULN);

12. Willing and able to comply with scheduled visits, treatment plan, laboratory tests,
and other study procedures;

13. Male participants must agree to use a highly effective method of contraception
throughout the study and for at least 180 days after the last dose of assigned
treatment;

14. If female, must be at least 2 years post-menopausal (defined as post-menopausal with
at least 24 consecutive months without menstruation) or documented surgically sterile.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Part 1a, monotherapy dose escalation: Prior therapy for advanced NSCLC within 6 weeks
prior to Day 1; Part 1b and Part 2, combination dose escalation and expansion: Prior
treatment with an ICI;

2. Continuous systemic treatment with either corticosteroids (> 10 mg daily prednisone
equivalents) or other immunosuppressive medications within 4 weeks prior to first dose
of study treatment. Inhaled or topical steroids and physiological replacement doses of
up to 10 mg daily prednisone equivalents are permitted in the absence of active
auto-immune disease;

3. Any previous grade 3 or higher toxicity to an ICI;

4. Known brain metastases requiring steroid treatment, or signs and symptoms indicating
suspected brain metastases;

5. Current or previous history of auto-immune disease;

6. NSCLC expressing epidermal growth factor receptor (EGFR), anaplastic lymphoma kinase
(ALK), B-Raf proto-oncogene (BRAF) or ROS proto-oncogene 1 (ROS1) mutations;

7. Prior organ transplant;

8. Concurrent active malignancy except for adequately controlled limited basal cell
carcinoma of the skin;

9. 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;

10. Active infection requiring intravenous antibiotics;

11. Positive for human immunodeficiency virus (HIV) (HIV 1/2 antibodies) or active
hepatitis B (HBsAg reactive) or active hepatitis C (HCV ribonucleic acid [RNA]
qualitative) infection;

12. Major surgery within 4 weeks prior to study entry. Minor surgery (excluding diagnostic
biopsy) within 1 week prior to study entry;

13. Has received a live-virus vaccination within 4 weeks of first dose of IMU-201.
Seasonal flu vaccines that do not contain live virus are permitted;

14. Current or recent (within 6 weeks of first IMU-201 dose) treatment with another
investigational drug or participation in another investigational study.

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
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
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
The phase 1 study is an open label, multi-center, non-randomized, dose escalation and
expansion study designed to assess the safety, tolerability, and immunogenicity of
IMU-201(PD1-Vaxx) as monotherapy and in combination with Standard of Care (SOC) treatment in
participants with PD-L1 expressing non-small cell lung cancer (NSCLC).
Trial website
https://clinicaltrials.gov/show/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
Anthony J Good, PhD
Address 0 0
Country 0 0
Phone 0 0
+61 410 711 329
Fax 0 0
Email 0 0
anthony.good@imugene.com
Contact person for scientific queries

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