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RECRUITING
NCT06242470
PHASE1

A Study of MGC026 in Participants With Advanced Solid Tumors

Sponsor: MacroGenics

View on ClinicalTrials.gov

Summary

The study is designed to understand the safety, tolerability, pharmacokinetics, immunogenicity, and preliminary antitumor activity of vobramitamab tavatecan (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 in Module A of the study. Combination therapy with pembrolizumab will occur in Module B of the study Participants will receive vobramitamab tavatecan by intravenous (IV) infusion. The dose of vobramitamab tavatecan will be assigned at the time of enrollment. Pembrolizumab will be administered at 200 mg every 3 weeks. 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 and tumor samples collected for research purposes.

Official title: A Phase 1/1b First-in-Human, Open Label, Dose Escalation and Cohort Expansion Study of MGC026 in Participants With Advanced Solid Tumors

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

394

Start Date

2024-03-06

Completion Date

2029-04

Last Updated

2026-10-28

Healthy Volunteers

No

Interventions

BIOLOGICAL

MGC026 Dose Escalation

Escalating doses of MGC026

BIOLOGICAL

MGC026 Dose for Expansion

MGC026 recommended dose for expansion

BIOLOGICAL

Pembrollizumab

200 mg, IV, every 3 weeks.

BIOLOGICAL

vobramitamab tavatecan

less than RDE dose level, IV, every 3 weeks

Locations (12)

The Angeles Clinic and Research Institute

Los Angeles, California, United States

START Midwest

Grand Rapids, Michigan, United States

START-New York Long Island

Lake Success, New York, United States

Providence Cancer Institute

Portland, Oregon, United States

The University of Texas MD Anderson Cancer Center

Houston, Texas, United States

University of Texas Health Science Center at Houston

Houston, Texas, United States

START Mountain Region

West Valley City, Utah, United States

ICON Cancer Centre Wesley

Auchenflower, Queensland, Australia

ICON Cancer Centre Kurralta Park

Kurralta Park, South Australia, Australia

Austin Health- Olivia Newton John Cancer Center

Heidelberg, Victoria, Australia

Oxford University Hospitals NHS Foundation Trust

Oxford, United Kingdom

The Royal Marsden NHS Foundation Trust

Sutton, United Kingdom