The primary purpose of this research study is to evaluate how safe, how well tolerated and how effective a range of doses of L-DOS47 in patients with non-squamous non-small cell lung cancer when given as a monotherapy.
Patients will be recruited into cohorts, with a minimum of three and a maximum of six patients per cohort. All patients at a given dose level must complete Cycle 1 (3 week period) before escalation in subsequent patients can proceed. The decision for dose escalation to the next dose level will be made after the safety and available pharmacokinetic (PK) data have been reviewed by the Trial Steering Committee (TSC). Escalation of L-DOS47 will continue until a maximum tolerated dose (MTD) is reached. After the MTD of L-DOS47 has been determined in Phase I, up to 20 patients will be enrolled (taken forward from Phase I) to evaluate the preliminary efficacy of L-DOS47 (i.e., response rate using the Response Evaluation Criteria in Solid Tumours \[RECIST\] version 1.1 criteria, disease progression and survival); monitoring will include radiologic evaluations every second cycle. The safety and tolerability of L-DOS47 will also be further evaluated. Pharmacokinetic information will be collected as well as relevant observations on the activity of L-DOS47. For all patients, treatment with L-DOS47 will continue either until the patient experiences disease progression, unacceptable toxicity, the patient withdraws consent or has completed four treatment cycles and does not wish to continue with additional cycles, whichever occurs first. After four cycles, patients may continue to receive L-DOS47 for as long as there is sustained clinical benefit and it is well tolerated, in the opinion of the Investigator.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
76
A treatment cycle will be 21 days with patients receiving L-DOS47 on cycle Days 1 and 8.
Mazovian Center of Pulmonary Diseases and Tuberculosis
Otwock, Poland
Med. Polonia Hospital Poznan
Poznan, Poland
Institute of Tuberculosis and Lung Diseases
Warsaw, Poland
Military Medical Institute
Warsaw, Poland
The incidence and severity of drug-related adverse events as a measure of safety and tolerability of L-DOS47
Assessed during the AE reporting period starts on Cycle 1 Day 1 up to the last study visit.
Time frame: Up to 12 weeks
L-DOS47 related toxicity during the first 2 hours after infusion
Assessed by the incidence and severity of AEs and SAEs and changes in vital signs
Time frame: During the first 2 hours after infusion
The incidence and severity of all reported adverse events and serious adverse events
Assessed during the AE reporting period starts on Cycle 1 Day 1 up to the last study visit.
Time frame: Participants will be followed for 12 weeks and the 30 day follow-up period
Changes from baseline for additional safety parameters (clinical laboratory assessments, vital signs, weight, oxygen requirement and 12-lead ECG)
Safety parameters include clinical laboratory assessments, vital signs, weight, oxygen requirement and 12-lead ECG
Time frame: Up to 12 weeks
The evaluation of anti-L-DOS47 antibody over time
Serum samples will be collected and analyzed from all patients dosed with L-DOS47.
Time frame: Up to 12 weeks
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The Maria Sklodowska-Curie Memorial Cancer Centre & Institute of Oncology
Warsaw, Poland