Trial Title:
MGC018 in Patients With Relapsed or Refractory Extensive-Stage Small-Cell Lung Cancer
NCT ID:
NCT06227546
Condition:
Extensive-stage Small-cell Lung Cancer
Conditions: Official terms:
Lung Neoplasms
Small Cell Lung Carcinoma
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
MGC018
Description:
Intravenous (IV) Infusion, 2.7 mg/kg on Day 1 of each 28 day cycle
Arm group label:
MCG018
Summary:
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.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Age greater than or equal to 18 years at time of signing Informed consent form (ICF)
2. Ability to comply with the study protocol, in the investigator's judgment.
3. 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.
4. Disease progression during or following treatment with platinum-based chemotherapy.
a) Patients could have received any number of therapies for relapsed or progressive
disease.
5. Measurable disease per RECIST v1.1
6. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-2
7. Adequate hematologic and end-organ function, defined by the following laboratory
test results, obtained within 14 days prior to initiation of study treatment:
1. Absolute Neutrophil Count (ANC) greater than or equal to (>/=) 1.0 x 10^9/L
(1000/uL) without granulocyte colony-stimulating factor support
2. Platelet count >/=100 x 10^9/L (100,000/uL) without transfusion
3. Hemoglobin >/= 80 g/L (8 g/dL) (1) Patients may be transfused to meet this
criterion.
4. Aspartate Aminotransferase (AST), Alanine Transaminase (ALT), and alkaline
phosphatase (ALP) less than or equal to (/= 30 mL/min (calculated using the Cockcroft-Gault
formula)
7. For patients not receiving therapeutic anticoagulation: international
normalized ratio (INR) and Partial Thromboplastin Time, Activated (aPTT) /= 12 continuous months of amenorrhea
with no identified cause other than menopause), and has not undergone surgical
sterilization (removal of ovaries and/or uterus). The definition of
childbearing potential may be adapted for alignment with local guidelines or
requirements.
3. Examples of contraceptive methods with a failure rate of < 1% per year include
bilateral tubal ligation, male sterilization, hormonal contraceptives that
inhibit ovulation, hormone-releasing intrauterine devices, and copper
intrauterine devices.
4. The reliability of sexual abstinence should be evaluated in relation to the
duration of the clinical trial and the preferred and usual lifestyle of the
patient. Periodic abstinence (e.g., calendar, ovulation, symptothermal, or
postovulation methods) and withdrawal are not adequate methods of
contraception.
11. For men: agreement to remain abstinent (refrain from heterosexual intercourse) or
use contraceptive measures, and agreement to refrain from donating sperm, as defined
below:
1. With a female partner of childbearing potential who is not pregnant, men who
are not surgically sterile must remain abstinent or use a condom plus an
additional contraceptive method that together result in a failure rate of < 1%
per year during the treatment period and for 90 days after the final dose of
MGC018. Men must refrain from donating sperm during this this same period.
2. With a pregnant female partner, men must remain abstinent or use a condom
during the treatment period and 90 days after the final dose of MGC018 to avoid
potential exposure to the embryo.
3. The reliability of sexual abstinence should be evaluated in relation to the
duration of the clinical trial and the preferred and usual lifestyle of the
patient. Periodic abstinence (e.g., calendar, ovulation, symptothermal, or
postovulation methods) and withdrawal are not adequate methods of
contraception.
Exclusion Criteria:
1. Patients with treated brain metastases are eligible if they are symptomatically
stable while off steroid therapy for a minimum of 7 days
2. History of leptomeningeal disease
3. Patient who are receiving any other investigational agents
4. Major surgical procedure, other than for diagnosis, within 4 weeks prior to
initiation of study treatment, or anticipation of need for a major surgical
procedure during the study
5. Diagnosis of another malignancy. However, patients with prior or concurrent
malignancy whose natural history or treatment does not have the potential to
interfere with the safety or efficacy assessment of the investigational regimen are
eligible for this trial.
6. Evidence of pleural and/or pericardial effusion. A small and/or asymptomatic
effusion is not exclusionary.
7. Any other disease, metabolic dysfunction, physical examination finding, or clinical
laboratory finding that, in the view of the investigator, contraindicates the use of
an investigational drug, may affect the interpretation of the results, or may render
the patient at high risk from treatment complications.
8. Pregnancy or breastfeeding, or intention of becoming pregnant during study treatment
or within 6 months after the final dose of study treatment.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Lombardi Comprehensive Cancer Center, Georgetown University
Address:
City:
Washington
Zip:
20007
Country:
United States
Status:
Recruiting
Contact:
Last name:
Emma Dimeo
Phone:
202-784-5067
Email:
Emma.G.Dimeo@medstar.net
Investigator:
Last name:
Chul Kim, MD
Email:
Principal Investigator
Facility:
Name:
Medstar Washington Hospital Center
Address:
City:
Washington
Zip:
20010
Country:
United States
Status:
Not yet recruiting
Investigator:
Last name:
Irina Veystman, MD
Email:
Principal Investigator
Facility:
Name:
The Harry and Jeanette Weinberg Cancer Institute at MedStar Franklin Square Medical Center
Address:
City:
Baltimore
Zip:
21237
Country:
United States
Status:
Not yet recruiting
Investigator:
Last name:
Kevin Chen, MD
Email:
Principal Investigator
Facility:
Name:
Hackensack Meridian Health, John Theurer Cancer Center
Address:
City:
Hackensack
Zip:
07601
Country:
United States
Status:
Not yet recruiting
Investigator:
Last name:
Martin Gutierrez, MD
Email:
Principal Investigator
Start date:
April 15, 2024
Completion date:
May 2026
Lead sponsor:
Agency:
Georgetown University
Agency class:
Other
Collaborator:
Agency:
MacroGenics
Agency class:
Industry
Source:
Georgetown University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06227546
