Brief Title
A Study of IMU-201 (PD1-Vaxx), a B-Cell Immunotherapy, in Adults With Non-Small Cell Lung Cancer
Official 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
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 in patients with PD-L1 expressing non-small cell lung cancer
(NSCLC).
Detailed Description
Investigational Medicinal Product, IMU-201, consists of drug substance, APi2568, which is a
B-cell epitope (amino acids 92-110 from PD-1) linked to a promiscuous T-cell epitope (amino
acid residues 288-302 from measles virus fusion protein) via a 4-amino acid linker
(Gly-Pro-Ser-Leu), and combined with Water for Injection (WFI) forms the drug product,
IMU-201, which becomes PD1-Vaxx when emulsified with excipient Montanide ISA 720 VG.
It is hypothesized that a polyclonal induced B-cell antibody response will be more effective
or as effective with improved safety over current monoclonal antibody therapy.
This phase 1 study is designed to assess the safety, tolerability, and immunogenicity of
IMU-201 (PD1-Vaxx) as monotherapy in patients with PD-L1 expressing non-small cell lung
cancer (NSCLC). The monotherapy dose-escalation of IMU-201 (PD1-Vaxx) will establish the
optimal biological dose. Once established, the dose cohort will be expanded to a total of 10
participants. Once the monotherapy optimal biological dose is established and expansion
complete, the protocol will be modified to include a combination dose escalation with
standard of care treatment.
Study Phase
Phase 1
Study Type
Interventional
Primary Outcome
Safety and tolerability of IMU-201 as monotherapy graded per terminology criteria for adverse events (CTCAE) version 5.00
Secondary Outcome
Overall response rate (ORR)
Condition
Non Small Cell Lung Cancer
Intervention
IMU-201 (administered as PD1-Vaxx)
Study Arms / Comparison Groups
Dose Escalation: Monotherapy Cohort 1
Description: 10 μg/dose IMU-201 as a 0.5 mL PD1-Vaxx injection
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
22
Start Date
November 30, 2020
Completion Date
July 2023
Primary Completion Date
December 2022
Eligibility Criteria
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. Progressed on an approved PD-1 inhibitor or an approved PD-L1 inhibitor. Patients
previously treated with a combination of an approved PD-1 or an approved anti-PD-L1
inhibitor and chemotherapy may be included with agreement of Imugene Limited;
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;
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.
Exclusion Criteria:
1. Prior therapy for advanced NSCLC within 6 weeks prior to Day 1;
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 a PD-1 inhibitor or PD-L1 inhibitor;
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.
Gender
All
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
, 03 9824 5254, [email protected]
Location Countries
Australia
Location Countries
Australia
Administrative Informations
NCT ID
NCT04432207
Organization ID
IMU.201.101
Responsible Party
Sponsor
Study Sponsor
Imugene Limited
Study Sponsor
, ,
Verification Date
January 2022