Actively Recruiting

Phase 1
Age: 18Years +
All Genders
NCT06242470

A Study of MGC026 in Participants With Advanced Solid Tumors

Led by MacroGenics · Updated on 2026-02-05

250

Participants Needed

12

Research Sites

238 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

A Study of MGC026 in Participants With Advanced Solid Tumors

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adults 18 years or older able to provide informed consent
  • Adequate performance and lab test results
  • Availability of archival or fresh tumor tissue sample for testing
  • Unresectable, locally advanced or metastatic solid tumors including specific cancer types listed
  • Measurable disease by RECIST v1.1 or metastatic castration resistant prostate cancer without measurable disease
  • Willingness to use effective birth control from consent through 7 months after treatment
  • Not pregnant or breastfeeding
Not Eligible

You will not qualify if you...

  • Medical or psychiatric conditions that interfere with treatment or study procedures
  • Another cancer treated within past 2 years except low-risk skin or prostate cancers
  • Prior central nervous system metastasis unless treated, asymptomatic, and stable
  • Recent surgery or cancer treatments within protocol-specified intervals
  • Prior treatment with B7-H3 targeted agents or ADCs with topoisomerase payloads
  • Prior stem cell or solid organ transplant
  • Significant cardiovascular, lung, or gastrointestinal disorders
  • Active infections requiring intravenous treatment within 1 week before study drug
  • Known hepatitis B or C infection or positive tests
  • Known HIV infection or AIDS history
  • History of primary immunodeficiency
  • Major trauma or surgery within 4 weeks before study drug
  • Known allergy to recombinant proteins

AI-Screening

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Trial Site Locations

Total: 12 locations

1

The Angeles Clinic and Research Institute

Los Angeles, California, United States, 90025

Actively Recruiting

2

START Midwest

Grand Rapids, Michigan, United States, 49546

Actively Recruiting

3

START-New York Long Island

Lake Success, New York, United States, 11042

Actively Recruiting

4

Providence Cancer Institute

Portland, Oregon, United States, 97213

Actively Recruiting

5

The University of Texas MD Anderson Cancer Center

Houston, Texas, United States, 77030

Actively Recruiting

6

University of Texas Health Science Center at Houston

Houston, Texas, United States, 77030

Actively Recruiting

7

START Mountain Region

West Valley City, Utah, United States, 84119

Actively Recruiting

8

ICON Cancer Centre Wesley

Auchenflower, Queensland, Australia, 4066

Actively Recruiting

9

ICON Cancer Centre Kurralta Park

Kurralta Park, South Australia, Australia, 5037

Actively Recruiting

10

Austin Health- Olivia Newton John Cancer Center

Heidelberg, Victoria, Australia, 3084

Actively Recruiting

11

Oxford University Hospitals NHS Foundation Trust

Oxford, United Kingdom, OX3 9DU

Actively Recruiting

12

The Royal Marsden NHS Foundation Trust

Sutton, United Kingdom, SM2 5PT

Actively Recruiting

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Research Team

G

Global Trial Manager

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

SEQUENTIAL

Primary Purpose

TREATMENT

Number of Arms

12

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