Clinical Trials

Inclusion Criteria:

• 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.
• Parts 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. Participants with non-measurable lesions may be included with agreement of Imugene Limited.
• Adequate hematologic function: absolute neutrophil count (ANC) > 1.5x10^9/L, platelet count at > ^/L, and hemoglobin > 9 g/dL.
• Adequate liver function evidenced by bilirubin at < 1.5 x 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 < 1.5 x laboratory ULN).
• Willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
• Male participants must agree not to donate sperm and 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;
  • Parts 1b and 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.