A Study of IMU-201 (PD1-Vaxx), a B-Cell Immunotherapy, in Adults With Non-Small Cell Lung Cancer
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
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).
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.
Safety and tolerability of IMU-201 as monotherapy graded per terminology criteria for adverse events (CTCAE) version 5.00
Overall response rate (ORR)
Non Small Cell Lung Cancer
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
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
November 30, 2020
Primary Completion Date
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.
18 Years - N/A
Accepts Healthy Volunteers
, 03 9824 5254, [email protected]