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| Name | Class |
|---|---|
| MacroGenics | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MCG018 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MGC018 | Drug | Intravenous (IV) Infusion, 2.7 mg/kg on Day 1 of each 28 day cycle |
|
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate (ORR) | Investigator-Assessed ORR per Response Evaluation Criteria In Solid Tumors (RECIST v1.1) for target lesions as assessed by CT or magnetic resonance imaging (MRI) scans (with IV contrast unless contraindicated) of the chest, abdomen, and pelvis every 2 cycles (each cycle is a 28 day cycle). Reported as the number of patients with a complete response (CR) or partial response (PR); ORR = CR+PR; CR = Disappearance of all target lesions.Any pathological lymph nodes (whether target ornon-target) must have reduction in short axis to<10 mm. PR= At least a 30% decrease in the sum ofdiameters of target lesions, taking as reference the baseline sum diameters. | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Adverse Events | Number of participants with Investigator assessed treatment emergent adverse events per Common terminology criteria for adverse effects (CTCAE) version 5.0 | from start of treatment through 60 days after last treatment, approximately 1 year |
| Duration of Response (DOR) |
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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:
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| Name | Affiliation | Role |
|---|---|---|
| Chul Kim, MD | Chul.Kim@gunet.georgetown.edu | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lombardi Comprehensive Cancer Center, Georgetown University | Washington D.C. | District of Columbia | 20007 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | MCG018 | MGC018: Intravenous (IV) Infusion, 2.7 mg/kg on Day 1 of each 28 day cycle |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | MCG018 | MGC018: Intravenous (IV) Infusion, 2.7 mg/kg on Day 1 of each 28 day cycle |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Objective Response Rate (ORR) | Investigator-Assessed ORR per Response Evaluation Criteria In Solid Tumors (RECIST v1.1) for target lesions as assessed by CT or magnetic resonance imaging (MRI) scans (with IV contrast unless contraindicated) of the chest, abdomen, and pelvis every 2 cycles (each cycle is a 28 day cycle). Reported as the number of patients with a complete response (CR) or partial response (PR); ORR = CR+PR; CR = Disappearance of all target lesions.Any pathological lymph nodes (whether target ornon-target) must have reduction in short axis to<10 mm. PR= At least a 30% decrease in the sum ofdiameters of target lesions, taking as reference the baseline sum diameters. | Posted | Count of Participants | Participants | 1 year |
|
Serious Adverse events were collected from time of consent through 30 days after the final dose (approximately 38 weeks). Non-serious Adverse Events were collected from time of initiation of study treatment until 30 days after the final dose of study treatment (approximately 36 weeks). All cause mortality from time of consent to death or termination of the study, up to 2 years.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | MCG018 | MGC018: Intravenous (IV) Infusion, 2.7 mg/kg on Day 1 of each 28 day cycle |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Atrial fibrillation | Cardiac disorders | CTCAE (5.0) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anemia | Blood and lymphatic system disorders | CTCAE (5.0) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chul Kim, MD, MPH | Georgetown University | 202-444-2223 | chul.kim@gunet.georgetown.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 24, 2024 | Mar 3, 2026 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D055752 | Small Cell Lung Carcinoma |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
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Defined as the time from response to disease progression or death in patients who achieve complete or partial response. |
| 1 year |
| Progression-free Survival (PFS) Median | Defined as the time from study drug initiation until progression event or death as assessed using the Kaplan-Meier method. | 1 year |
| Progression-free Survival (PFS) 6 Months | Defined as the time from study drug initiation until progression event or death as assessed using the Kaplan-Meier method. | 6 months |
| Overall Survival (OS) | Defined as time from study drug initiation to death as assessed using the Kaplan-Meier method. | 3 years |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Secondary | Incidence of Adverse Events | Number of participants with Investigator assessed treatment emergent adverse events per Common terminology criteria for adverse effects (CTCAE) version 5.0 | Not Posted | from start of treatment through 60 days after last treatment, approximately 1 year | Participants |
| Secondary | Duration of Response (DOR) | Defined as the time from response to disease progression or death in patients who achieve complete or partial response. | Not Posted | 1 year | Participants |
| Secondary | Progression-free Survival (PFS) Median | Defined as the time from study drug initiation until progression event or death as assessed using the Kaplan-Meier method. | Not Posted | 1 year | Participants |
| Secondary | Progression-free Survival (PFS) 6 Months | Defined as the time from study drug initiation until progression event or death as assessed using the Kaplan-Meier method. | Not Posted | 6 months | Participants |
| Secondary | Overall Survival (OS) | Defined as time from study drug initiation to death as assessed using the Kaplan-Meier method. | Not Posted | 3 years | Participants |
| 6 |
| 9 |
| 4 |
| 9 |
| 9 |
| 9 |
| Lung infection | Infections and infestations | CTCAE (5.0) | Systematic Assessment |
|
| Sepsis | Infections and infestations | CTCAE (5.0) | Systematic Assessment |
|
| Creatinine increased | Investigations | CTCAE (5.0) | Systematic Assessment |
|
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | CTCAE (5.0) | Systematic Assessment |
|
| Rash maculo-papular | Skin and subcutaneous tissue disorders | CTCAE (5.0) | Systematic Assessment |
|
| Hypotension | Vascular disorders | CTCAE (5.0) | Systematic Assessment |
|
| Atrial fibrillation | Cardiac disorders | CTCAE (5.0) | Systematic Assessment |
|
| Sinus tachycardia | Cardiac disorders | CTCAE (5.0) | Systematic Assessment |
|
| Blurred vision | Eye disorders | CTCAE (5.0) | Systematic Assessment |
|
| Eye disorders - Other, specify | Eye disorders | CTCAE (5.0) | Systematic Assessment | Blepharitis |
|
| Periorbital edema | Eye disorders | CTCAE (5.0) | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | CTCAE (5.0) | Systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | CTCAE (5.0) | Systematic Assessment |
|
| Mucositis oral | Gastrointestinal disorders | CTCAE (5.0) | Systematic Assessment |
|
| Oral pain | Gastrointestinal disorders | CTCAE (5.0) | Systematic Assessment |
|
| Edema limbs | General disorders | CTCAE (5.0) | Systematic Assessment |
|
| Facial pain | General disorders | CTCAE (5.0) | Systematic Assessment |
|
| Fatigue | General disorders | CTCAE (5.0) | Systematic Assessment |
|
| Non-cardiac chest pain | General disorders | CTCAE (5.0) | Systematic Assessment |
|
| Conjunctivitis | Infections and infestations | CTCAE (5.0) | Systematic Assessment |
|
| Thrush | Infections and infestations | CTCAE (5.0) | Systematic Assessment |
|
| Upper respiratory infection | Immune system disorders | CTCAE (5.0) | Systematic Assessment |
|
| Fall | Injury, poisoning and procedural complications | CTCAE (5.0) | Systematic Assessment |
|
| Aspartate aminotransferase increased | Investigations | CTCAE (5.0) | Systematic Assessment |
|
| Creatinine increased | Investigations | CTCAE (5.0) | Systematic Assessment |
|
| Lymphocyte count decreased | Investigations | CTCAE (5.0) | Systematic Assessment |
|
| Neutrophil count decreased | Investigations | CTCAE (5.0) | Systematic Assessment |
|
| Platelet count decreased | Investigations | CTCAE (5.0) | Systematic Assessment |
|
| Weight loss | Investigations | CTCAE (5.0) | Systematic Assessment |
|
| Anorexia | Metabolism and nutrition disorders | CTCAE (5.0) | Systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | CTCAE (5.0) | Systematic Assessment |
|
| Hypophosphatemia | Metabolism and nutrition disorders | CTCAE (5.0) | Systematic Assessment |
|
| Dysgeusia | Nervous system disorders | CTCAE (5.0) | Systematic Assessment |
|
| Memory impairment | Nervous system disorders | CTCAE (5.0) | Systematic Assessment |
|
| Dyspnea | Respiratory, thoracic and mediastinal disorders | CTCAE (5.0) | Systematic Assessment |
|
| Hypoxia | Respiratory, thoracic and mediastinal disorders | CTCAE (5.0) | Systematic Assessment |
|
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | CTCAE (5.0) | Systematic Assessment |
|
| Palmar-plantar erythrodysesthesia syndrome | Skin and subcutaneous tissue disorders | CTCAE (5.0) | Systematic Assessment |
|
| Rash acneiform | Skin and subcutaneous tissue disorders | CTCAE (5.0) | Systematic Assessment |
|
| Rash maculo-papular | Skin and subcutaneous tissue disorders | CTCAE (5.0) | Systematic Assessment |
|
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| D013899 |
| Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |