Actively Recruiting
Phase 1/1b Study of MGC026 in Adults With Advanced Solid Tumors Receiving Intravenous Treatment Every 3 Weeks
Led by MacroGenics · Updated on 2026-02-05
250
Participants Needed
12
Research Sites
21 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety, tolerability, pharmacokinetics, immunogenicity, and early antitumor activity of MGC026 in adults with relapsed or refractory, unresectable, locally advanced, or metastatic solid tumors. This Phase 1/1b study involves a dose escalation phase followed by a cohort expansion to better understand how this treatment works and its effects on various advanced cancers. Participants will receive MGC026, a topoisomerase 1 inhibitor-based antibody-drug conjugate targeting B7-H3, given by intravenous infusion every three weeks. The dose will be assigned at enrollment, and participants may receive up to 35 treatments if side effects are manageable and the cancer does not worsen. The study includes several experimental cohorts during the escalation and expansion phases. During the study, participants will be closely monitored for side effects and cancer progression. Blood samples will be collected for routine lab tests and research. Researchers will measure adverse events, overall response rate, duration of response, drug levels in the blood, and immune responses over a period of up to 135 weeks. This thorough monitoring helps assess the treatment’s impact and safety throughout the study period.
CONDITIONS
Brief Title
A Study of MGC026 in Participants With Advanced Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults 18 years or older able to provide informed consent
- Adequate performance status and laboratory results
- Available archival tumor tissue sample or ability to safely undergo fresh tumor biopsy
- Diagnosed with unresectable, locally advanced or metastatic solid tumors including specified cancer types
- Measurable disease per RECIST v1.1 or metastatic castration-resistant prostate cancer without measurable disease
- Willing to use highly effective birth control during and 7 months after treatment
- Not pregnant or breastfeeding
You will not qualify if you...
- Medical or psychiatric conditions impairing ability to comply with treatment or procedures
- Another cancer requiring treatment within past 2 years except low-risk cancers
- Prior central nervous system metastasis with active or progressing disease
- Recent treatment with surgery, systemic therapy, immunotherapy, CAR-T, or anti-hormonal therapy within specified intervals
- Previous treatment with B7-H3 targeted agents or ADC with topoisomerase payload
- Prior stem cell or solid organ transplant
- Significant cardiovascular, pulmonary, or gastrointestinal disorders
- Active infection requiring parenteral treatment within 1 week before study drug
- Known hepatitis B or C infection or positive hepatitis tests
- Positive HIV test or history of AIDS
- History of primary immunodeficiency
- Major trauma or surgery within 4 weeks before first study drug
- Known hypersensitivity to recombinant proteins
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 135 weeks
Participants receive escalating doses of MGC026 administered intravenously every 3 weeks.
Visits every 3 weeks for intravenous treatment
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
Research Team
G
Global Trial Manager
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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