Preclinical Development of MGC028, an ADAM9-Targeted, Glycan-Linked, Exatecan-Based Antibody-Drug Conjugate for the Treatment of Solid Cancers.
Juniper A Scribner, Jennifer G Brown, Thomas Son...
https://pubmed.ncbi.nlm.nih.gov/41166694Actively Recruiting
Phase 1
Age: 18Years +
All Genders
ID06723236
A Phase 1, First-in-Human, Open Label, Dose Escalation and Cohort Expansion Study of MGC028 in Participants With Advanced Solid Tumors
Led by MacroGenics · Updated on 2026-04-27
124
Participants Needed
7
Research Sites
21 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating MGC028, an antibody-drug conjugate targeting ADAM9, in adults with relapsed or refractory advanced solid tumors that cannot be surgically removed or have spread. The study aims to understand the safety, side effects, dose-limiting toxicities, and the maximum tolerated dose of MGC028. It also seeks to determine if MGC028 can shrink or control the progression of these cancers, including types such as non-small cell lung cancer adenocarcinoma, cholangiocarcinoma, pancreatic carcinoma, and colorectal carcinoma. Participants receive MGC028 through intravenous infusions at increasing dose levels every three weeks. The study includes dose escalation cohorts followed by expansion cohorts at the maximum tolerated or maximum administered dose. Treatment is administered in cycles, with dose levels ranging from 1 to 6 and additional expansion cohorts to further evaluate safety and response. During the trial, participants undergo screening to confirm eligibility, regular blood tests for routine and research purposes, and examinations to assess heart and lung function and overall health. Researchers monitor side effects and provide treatment if needed. Tumor status is assessed at regular intervals to evaluate response to MGC028. Outcome measures include the number and types of adverse events over up to 25 months, drug concentration levels in the blood, development of anti-drug antibodies, tumor response rates, duration of response, and changes in ADAM9 expression in tumor samples.
CONDITIONS
Brief Title
A Study of MGC028 in Participants With Advanced Solid Tumors
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Adults aged 18 years or older
- Histologically confirmed unresectable, locally advanced or metastatic solid tumor of NSCLC adenocarcinoma, cholangiocarcinoma, colorectal carcinoma, or pancreatic carcinoma
- Disease refractory to standard therapy or no standard therapy available, intolerable, or refused
- For expansion cohorts: specific prior treatments and progression criteria for NSCLC adenocarcinoma, pancreatic cancer, or colorectal adenocarcinoma
- At least one measurable lesion per RECIST v1.1
- Available archival tumor tissue or willingness to undergo biopsy
- Acceptable physical condition and laboratory values
- Agreement to use highly effective birth control if of childbearing potential
- Not pregnant, planning pregnancy, or breastfeeding
You will not qualify if you...
- Medical or psychiatric conditions impairing ability to participate or tolerate treatment
- Active brain or leptomeningeal metastases
- Prior stem cell, tissue, or solid organ transplant
- Another malignancy requiring treatment within past 2 years except low-risk cancers
- Active viral, bacterial, or fungal infections
- Prior treatment with ADAM9 targeted agents
- Major surgery, mediastinal or lung radiation, live virus vaccination, systemic cancer treatment, CAR-T therapy, or experimental treatment within 4 weeks before study treatment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - Up to approximately 18 weeks through Cycle 6 of treatment
Participants receive MGC028, an antibody-drug conjugate targeted against ADAM9, through intravenous infusions in dose escalation and cohort expansion phases.
Weekly visits for up to 18 weeks
Follow-up
Duration - Up to 2.5 years
Participants are monitored for safety, adverse events, and treatment response after completing treatment with MGC028.
Visits scheduled throughout follow-up period
Trial Site Locations
Total: 7 locations
1
UCSF - Helen Diller Family Cancer Center
San Francisco, California, United States, 94115
Actively Recruiting
2
Mass General Brigham
Boston, Massachusetts, United States, 02114
Actively Recruiting
3
Dana Farber/Harvard Cancer Center
Boston, Massachusetts, United States, 02115
Actively Recruiting
4
South Texas Accelerated Research Therapeutics (START) Midwest
Grand Rapids, Michigan, United States, 49546
Actively Recruiting
5
Icahn School of Medicine at Mt. Sinai
New York, New York, United States, 10029
Actively Recruiting
6
South Texas Accelerated Research Therapeutics (START) San Antonio
San Antonio, Texas, United States, 78229
Actively Recruiting
7
South Texas Accelerated Research Therapeutics (START) Mountain Region
West Valley City, Utah, United States, 84119
Actively Recruiting
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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
9
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