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

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

Status
Terminated
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01918930
Enrollment
6
Registered
2013-08-08
Start date
2013-07-31
Completion date
2016-10-31
Last updated
2022-02-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Melanoma

Keywords

Melanoma, Accessible tumors, B7-H3 positive tumors

Brief 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.

Interventions

BIOLOGICALMGA271

MGA271 anti-B7-H3 monoclonal antibody

Sponsors

Massachusetts General Hospital
CollaboratorOTHER
MacroGenics
Lead SponsorINDUSTRY

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Qualified, by meeting all inclusion and

Exclusion criteria

, for participation in Study CP-MGA271-01. * Must have provided informed consent to participate in Study CP-MGA271-01. * Must have accessible tumors (generally speaking, metastatic deposits involving skin, subcutaneous tissue, or peripheral lymph node whose excision, punch biopsy, or core needle biopsy would not require general anaesthesia or the invasion of a body cavity). * Willing to undergo two minor surgical procedures with no expectation of personal benefit * Have provided Informed Consent for this substudy as indicated by a signature on an approved consent document obtained from the patient or his/her legally authorized representative

Design outcomes

Primary

MeasureTime frameDescription
Mechanism of Actionup to 50 daysExploratory analyses from immunohistochemistry (IHC) and flow cytometry testing to determine the effect of MGA271 on tumor cells.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026