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

  • STATUS
    Recruiting
  • End date
    Dec 29, 2021
  • participants needed
    22
  • sponsor
    Imugene Limited
Updated on 29 January 2021
platelet count
cancer
measurable disease
carcinoma
lung cancer
neutrophil count
pd-l1
cancer chemotherapy
adenocarcinoma
large cell carcinoma
kidney function test
pd-1 inhibitor
lung carcinoma

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).

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.

Details
Condition Non-Small Cell Lung Cancer, Lung Adenocarcinoma, Non Small Cell Lung Cancer Stage IIIB, Squamous Non Small Cell Lung Cancer, Non-small Cell Lung Cancer Stage IV, Large Cell Carcinoma Lung, Adenocarcinoma Lung, Non-small Cell Lung Cancer Stage IV, Non-small Cell Lung Cancer Stage IV, Non-small Cell Lung Cancer Stage IV, Non-small Cell Lung Cancer Stage IV, Non-small Cell Lung Cancer Stage IV, nsclc, Non-small Cell Lung Cancer Stage IV, Non-small Cell Lung Cancer Stage IV, Non-small Cell Lung Cancer Stage IV
Treatment IMU-201 (administered as PD1-Vaxx), Standard of care treatment for NSCLC
Clinical Study IdentifierNCT04432207
SponsorImugene Limited
Last Modified on29 January 2021

Eligibility

Yes No Not Sure

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...?
Do you have any of these conditions: nsclc or Non-small Cell Lung Cancer Stage IV or Adenocarcinoma Lung or Non Small Cell Lung Cancer Stage IIIB or Squamous Non Small Cell Lung Cancer or...?
Do you have any of these conditions: Non Small Cell Lung Cancer Stage IIIB or Non-Small Cell Lung Cancer or Non-small Cell Lung Cancer Stage IV or Large Cell Carcinoma Lung or nsclc or Ad...?
Do you have any of these conditions: Adenocarcinoma Lung or Lung Adenocarcinoma or Squamous Non Small Cell Lung Cancer or Non Small Cell Lung Cancer Stage IIIB or Non-Small Cell Lung Canc...?
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)
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
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
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

Prior therapy for advanced NSCLC within 6 weeks prior to Day 1
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 a PD-1 inhibitor or PD-L1 inhibitor
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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