A Study of MGC026 in Participants With Advanced Solid Tumors

Summary

The study is designed to understand the safety, tolerability, pharmacokinetics, immunogenicity, and preliminary antitumor activity of MGC026 in participants with relapsed or refractory, unresectable, locally advanced or metastatic solid tumors The study has a dose escalation portion and a cohort expansion portion of the study.

Participants will receive MGC026 by intravenous (IV) infusion. The dose of MGC026 will be assigned at the time of enrollment. Participants may receive up to 35 treatments if there are no severe side effects and as long as the cancer does not get worse. Participants will be monitored for side effects, and progression of cancer, have blood samples collected for routing laboratory work, and blood samples collected for research purposes.

Conditions

• Advanced Solid Tumor
• Advanced Cancer
• Metastatic Cancer
• Squamous Cell Carcinoma of Head and Neck
• Non Small Cell Lung Cancer
• Small-cell Lung Cancer
• Bladder Cancer
• Sarcoma
• Endometrial Cancer
• Melanoma
• Castration Resistant Prostatic Cancer
• Cervical Cancer
• Colorectal Cancer
• Gastric Cancer
• Gastro-esophageal Cancer
• Pancreas Cancer
• Clear Cell Renal Cell Carcinoma
• Hepatocellular Carcinoma
• Platinum-resistant Ovarian Cancer
• Breast Cancer
• Ovarian Cancer
• Esophageal Squamous Cell Cancer (SCC)

Interventions

BIOLOGICAL

MGC026 Dose Escalation

Escalating doses of MGC026

BIOLOGICAL

MGC026 Dose for Expansion

MGC026 recommended dose for expansion

Sponsors & Collaborators

• MacroGenics

  lead INDUSTRY

Principal Investigators

• Denise Casey, MD · MacroGenics

Study Design

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

SEQUENTIAL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-03-06

Primary Completion

2028-05-31

Completion

2028-10-31

FDA Drug

Yes

Countries

• United States
• Australia
• United Kingdom

Study Locations