MGC018 in Patients With Relapsed or Refractory Extensive-Stage Small-Cell Lung Cancer

NCT06227546 | Active Not Recruiting Phase 2 Results DMC FDA Drug

• 1 other identifier: STUDY00007316
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Extensive-stage Small-cell Lung Cancer

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (5)

• Incidence of Adverse Events

  from start of treatment through 60 days after last treatment, approximately 1 year

• Duration of Response (DOR)

  1 year

• Progression-free Survival (PFS) Median

  1 year

• Progression-free Survival (PFS) 6 Months

  6 months

• Overall Survival (OS)

  3 years

Study Arms (1)

MCG018

EXPERIMENTAL

Drug: MGC018

Interventions

MGC018 DRUG

Intravenous (IV) Infusion, 2.7 mg/kg on Day 1 of each 28 day cycle

MCG018

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• Patients with documented liver metastases: AST and ALT \</= 5 x ULN
• Patients with documented liver or bone metastases: ALP \</= 5 x ULN
• Serum bilirubin \</= 1.5 x ULN with the following exception:

You may not qualify if:

• Patients with treated brain metastases are eligible if they are symptomatically stable while off steroid therapy for a minimum of 7 days
• History of leptomeningeal disease
• Patient who are receiving any other investigational agents
• 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
• 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.
• 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.
• Pregnancy or breastfeeding, or intention of becoming pregnant during study treatment or within 6 months after the final dose of study treatment.

Sponsors & Collaborators

• Georgetown University: lead
• MacroGenics: collaborator

Study Sites (1)

Lombardi Comprehensive Cancer Center, Georgetown University

Washington D.C., District of Columbia, 20007, United States

Location

MeSH Terms

Conditions

Small Cell Lung Carcinoma

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Results Point of Contact

• Title: Chul Kim, MD, MPH
• Organization: Georgetown University

chul.kim@gunet.georgetown.edu

202-444-2223

Study Officials

• Chul Kim, MD

  Chul.Kim@gunet.georgetown.edu

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 18, 2024
• First Posted: January 29, 2024
• Study Start: April 15, 2024
• Primary Completion: March 28, 2025
• Study Completion: May 1, 2026
• Last Updated: April 13, 2026
• Results First Posted: April 13, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)