NCT01918930

Tissue Procurement Substudy for Participants in Study CP-MGA271-01

A Tissue Procurement and Examination Substudy of Study CP-MGA271-01 (NCT01391143)

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 6 (actual)
• Sponsor: MacroGenics · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to gain a better understanding about how the study drug MGA271 works. No test drug will be given in this study. Patients with easily accessible tumors at the screening visit for participation in Study CP-MGA271-01 will be asked to participate in this substudy. Patients will undergo two excisional biopsies, punch biopsies, or core needle biopsies.

Detailed description

Patients with easily accessible tumors (generally, metastatic deposits involving skin, subcutaneous tissues, or peripheral lymph node whose excision would not require general anaesthesia or the invasion of a body cavity) at the screening visit for participation in Study CP-MGA271-01 (the main study) will be asked to participate in this substudy. After providing appropriate informed consent, patients will undergo excisional biopsy, punch biopsy, or core needle biopsy of the accessible tumor prior to receiving study drug in the main study and then again after the first cycle of study drug is completed. Some of the biopsy tissue will be sent to a central laboratory for research purposes. The central lab will analyze the tissue to see what effects that the study drug might have on tumors.

Conditions

• Melanoma

Interventions

Type	Name	Description
BIOLOGICAL	MGA271	MGA271 anti-B7-H3 monoclonal antibody

Timeline

• Start date: 2013-07-01
• Primary completion: 2016-10-01
• Completion: 2016-10-01
• First posted: 2013-08-08
• Last updated: 2022-02-08

Locations

7 sites across 1 country: United States