Inoperable, locally advanced, recurrent or metastatic non-squamous non-small cell lung cancer MedDRA version: 20.0 Level: PT Classification code 10061873 Term: Non-small cell lung cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Sponsors
Helix BioPharma Corp
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male or female aged = 18 years old 2. Have histologically confirmed non-squamous NSCLC. (If available at the site, the paraffin-fixed biopsy sample will be provided to the Sponsor.) 3. Have at least a single measurable lesion in accordance with the RECIST v1.1 criteria 4. Eastern Cooperative Oncology Group (ECOG) performance status: 0-2 5. Have a life expectancy of = 3 months 6. Have adequate organ function as determine by the following criteria: a. Absolute neutrophil count = 1.5 x 1000000000/L b. Platelet count = 100 x 1000000000/L c. Haemoglobin (HGB) = 9 g/dL d. Creatinine clearance = 60 mL/min calculated using the Cockcroft-Gault Formula or serum creatinine = 1.5 x upper limit of normal (ULN) e. Serum aspartate aminotransferase (AST) and serum alanine aminotransferase (ALT) = 3 x ULN, or =65 years) yes F.1.3.1 Number of subjects for this age range 32
Exclusion criteria
Exclusion criteria: Patients will not be entered in the study for any of the following reasons: 1. Are pregnant or nursing mother 2. Have a prior history of other malignancies with the exception of non-melanoma skin cancer 3.Have known history of central nervous system (CNS) metastatic disease (previously treated or untreated) 4. Show evidence of active infection 5. Have received treatment in another clinical study within the 30 days before commencing study treatment or have not recovered from side effects of a study drug, except for alopecia 6. Have a serious uncontrolled medical condition 7. Known positive human immunodeficiency virus (HIV), known hepatitis B surface antigen, or hepatitis C positive 8. Sustained QTc (the QT interval corrected for heart rate) with Fridericia's correction > 450 ms at Screening or a history of additional risk factors for Torsades de pointes (e.g., heart failure, hypokalemia, family history of long QT syndrome) 9. Pre-existing peripheral neurophathy = CTC Grade 2 10. Have dementia or significantly altered mental status that would prohibit the understanding or rendering of informed consent or compliance with the requirements of the protocol 11. Are receiving chemotherapy during the 30 days before study start; receiving radiotherapy, targeted therapy, hormonal therapy, immunotherapy, major surgery or other study drugs during the 4 weeks before study treatment start or have not recovered from all treatment related toxicities to Grade = 1, except for alopecia. (Radiotherapy is allowed for the symptomatic treatment of bone metastases.) 12. Are taking systemic steroids (other than inhalers or topical steroids) or other medication to suppress the immune system 13. Are participating (or planning to participate) in any other clinical trial during this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Phase I - To define the maximum tolerated doses of multiple doses of L-DOS47 administered intravenously to patients with non-squamous non-small cell lung cancer when given as monotherapy. Phase II - To make a preliminary assessment of the efficacy of L-DOS47 in patients with non-squamous non-small cell lung cancer.;Secondary Objective: Phase I and Phase II - To evaluate the pharmacokinetics of L-DOS47 in patients with non-squamous non-small cell lung cancer. - To evaluate the immunogenicity of L-DOS47 in patients with non-squamous non-small cell lung cancer - To evaluate the safety and tolerability of multiple doses of L-DOS47 in patients with non-squamous non-small cell lung cancer;Primary end point(s): Phase I - The incidence and severity of drug-related adverse events as per dose-limiting toxicity definition. Phase II - The overall response rate defined as the proportion of patients with a best (confirmed) objective response (RECIST v1.1) of complete response and partial response.;Timepoint(s) of evaluation of this end point: Phase I: = 3 weeks after start of treatment Phase II: End of treatment visit, or previous radiologic exam date if radiologic exam was performed < 6 weeks before the end of treatment visit | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): a. L-DOS47-related toxicity during the first 2 hours after infusion, assessed by: i.Incidence and severity of AEs and SAEs ii.changes in vital signs b. Incidence and severity of AEs and SAEs c. Changes from Baseline in the following additional safety parameters: clinical laboratory assessments, vital signs, weight, oxygen requirement and 12-lead ECG d. Changes in physical examination e. The evaluation of anti-L-DOS47 antibody over time ;Timepoint(s) of evaluation of this end point: a. 2 hours after start of infusion b. 30 days post last dose of study treatment c. D8, Day 15 of Cycle 4 (end of Cycle 4) 7 days after last dose. Early Termination, Cycle 5 and beyond Days 1 & 8 predose d. D8 Day 15 of Cycle 4 (end of Cycle 4) 7 days after last dose. Early Termination, Cycle 5 and beyond Days 1 & 8 predose, 30 days post last dose of study treatment e. 30 days post last dose of study treatment | — |
Countries
Poland
Contacts
Public ContactClinical Operations
Helix BioPharma Corp.
Outcome results
None listed