NCT06227546

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

A Phase II Study of MGC018 in Patients With Relapsed or Refractory Extensive-Stage Small-Cell Lung Cancer (ES-SCLC)

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 9 (actual)
• Sponsor: Georgetown University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DRUG	MGC018	Intravenous (IV) Infusion, 2.7 mg/kg on Day 1 of each 28 day cycle

Timeline

• Start date: 2024-04-15
• Primary completion: 2025-03-28
• Completion: 2026-05-01
• First posted: 2024-01-29
• Last updated: 2026-04-13
• Results posted: 2026-04-13

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study