Status and phase
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About
The goal of this clinical trial is to test MGC018 in patients with relapsed or refractory Extensive-Stage Small-Cell Lung Cancer (ES-SCLC). The main question it aims to answer is:
• Does the administration of MGC018 achieve a clinically meaningful response rate of 25% in patients with relapsed or refractory ES-SCLC?
Participants enrolled in the trial will receive MGC018 through an intravenous (IV) infusion, every 28 days until disease progression or unacceptable toxicity. Tumor assessment will be done every 2 cycles (28 day cycles). Blood samples will be taken for biomarker analysis before treatment, on cycle 3 day 1, and at progression. A pretreatment biopsies will be done.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
Age greater than or equal to 18 years at time of signing Informed consent form (ICF)
Ability to comply with the study protocol, in the investigator's judgment.
Histologically or cytologically confirmed advanced small cell lung cancer that is not amenable to definitive therapy. Patients with epidermal growth factor receptor (EGFR)-mutant Non Small Cell Lung Cancer (NSCLC) that has transformed to Small Cell Lung Cancer (SCLC) will be allowed if their SCLC has progressed following treatment with platinum-based chemotherapy.
Disease progression during or following treatment with platinum-based chemotherapy.
a) Patients could have received any number of therapies for relapsed or progressive disease.
Measurable disease per RECIST v1.1
Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-2
Adequate hematologic and end-organ function, defined by the following laboratory test results, obtained within 14 days prior to initiation of study treatment:
Absolute Neutrophil Count (ANC) greater than or equal to (>/=) 1.0 x 10^9/L (1000/uL) without granulocyte colony-stimulating factor support
Platelet count >/=100 x 10^9/L (100,000/uL) without transfusion
Hemoglobin >/= 80 g/L (8 g/dL) (1) Patients may be transfused to meet this criterion.
Aspartate Aminotransferase (AST), Alanine Transaminase (ALT), and alkaline phosphatase (ALP) less than or equal to (</=) 2.5 x upper limit of normal (ULN), with the following exceptions:
Serum bilirubin </= 1.5 x ULN with the following exception:
(1) Patients with known Gilbert disease: serum bilirubin </= 3 x ULN
Creatinine clearance >/= 30 mL/min (calculated using the Cockcroft-Gault formula)
For patients not receiving therapeutic anticoagulation: international normalized ratio (INR) and Partial Thromboplastin Time, Activated (aPTT) </= 1.5 x ULN
Ability to understand and the willingness to sign a written informed consent document.
Availability of pre-treatment tumor tissue via a fresh biopsy. If biopsy is not considered safe and medically feasible by the Investigator, the patient may be approved for enrollment after consultation with the Principal Investigator.
For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive methods, and agreement to refrain from donating eggs, as defined below:
For men: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures, and agreement to refrain from donating sperm, as defined below:
Exclusion criteria
Primary purpose
Allocation
Interventional model
Masking
17 participants in 1 patient group
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Central trial contact
Chul Kim, MD
Data sourced from clinicaltrials.gov
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