A Study of IMU-201 (PD1-Vaxx) a B-Cell Immunotherapy in Adults With Non-Small Cell Lung Cancer

  • STATUS
    Recruiting
  • End date
    Dec 6, 2022
  • participants needed
    32
  • sponsor
    Imugene Limited
Updated on 6 October 2020
Investigator
Louise Grice
Primary Contact
Macquarie University (1.3 mi away) Contact
+5 other location
cancer
measurable disease
lung cancer
neutrophil count
pd-l1
adenocarcinoma
kidney function test

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).

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 and in combination with Standard of Care (SOC) treatment in participants with PD-L1 expressing non-small cell lung cancer (NSCLC). The study consists of two parts. Part 1, monotherapy dose-escalation of IMU-201 (PD1-Vaxx) to establish an optimal biological dose as monotherapy (Part 1a) followed by a combination dose escalation with standard of care treatment to establish a combination optimal biological dose of IMU-201 (PD1-Vaxx)(Part 1b). Part 2 dose expansion, will further characterize the safety, tolerability, and immunogenicity of IMU-201 in combination with SOC treatment for NSCLC at the defined expansion dose-level from Part 1b.

Details
Treatment IMU-201 (administered as PD1-Vaxx), Standard of care treatment for NSCLC
Clinical Study IdentifierNCT04432207
SponsorImugene Limited
Last Modified on6 October 2020

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Eligibility

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Inclusion Criteria

Is your age greater than or equal to 18 yrs?
Gender: Male or Female
Do you have any of these conditions: Non Small Cell Lung Cancer Stage IIIB or Adenocarcinoma Lung or Non-small Cell Lung Cancer Stage IV or Squamous Non Small Cell Lung Cancer or Large Ce...?
Informed of the investigational nature of this study and has given written informed consent in accordance with institutional, local, and national guidelines
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)
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
Age of at least 18 years
Life expectancy of at least 12 weeks in the opinion of the Investigator
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
Zubrod/ECOG score performance status 0-1
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
Adequate hematologic function: Absolute neutrophil count (ANC) > 1.5x109/L, platelet count at > 100x109/L, and hemoglobin > 9 g/dL
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
Adequate renal function (creatinine at < 1.5x laboratory ULN)
Willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures
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
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

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
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
Any previous grade 3 or higher toxicity to an ICI
Known brain metastases requiring steroid treatment, or signs and symptoms indicating suspected brain metastases
Current or previous history of auto-immune disease
NSCLC expressing epidermal growth factor receptor (EGFR), anaplastic lymphoma kinase (ALK), B-Raf proto-oncogene (BRAF) or ROS proto-oncogene 1 (ROS1) mutations
Prior organ transplant
Concurrent active malignancy except for adequately controlled limited basal cell carcinoma of the skin
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
Active infection requiring intravenous antibiotics
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
Major surgery within 4 weeks prior to study entry. Minor surgery (excluding diagnostic biopsy) within 1 week prior to study entry
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
Current or recent (within 6 weeks of first IMU-201 dose) treatment with another investigational drug or participation in another investigational study
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