Actively Recruiting
A Study of MGC028 in Participants With Advanced Solid Tumors
Led by MacroGenics · Updated on 2026-04-27
124
Participants Needed
7
Research Sites
111 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The goal of this clinical trial is to characterize the safety, tolerability, dose-limiting toxicities (DLT), and maximum tolerated dose (MTD) or maximum administered dose of MGC028 (if no MTD is defined). The study will enroll adult participants with relapsed or refractory, unresectable, locally advanced of metastatic solid tumors known to express ADAM9. The main question the study aims to answer is: * What types of side effects will participants experience when receiving MGC028? * Can MGC028 cause cancer to shrink, remain stable, or able to control disease progression of participants with advanced solid tumors? Participants will * Undergo screening procedures to determine eligibility * Receive study treatments initially every 3 weeks. * Have blood samples taken for routine and research tests * Have other examinations to check heart and lung function, and general health status * Be asked about any side effects that may be happening or other medications you are taking. The study doctor will provide treatment for side effects, if necessary. * Have the study doctor assess your tumor status at regular intervals to determine how you are responding to treatment.
CONDITIONS
Official Title
A Study of MGC028 in Participants With Advanced Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults with histologically confirmed unresectable, locally advanced, or metastatic solid tumors limited to NSCLC adenocarcinoma, cholangiocarcinoma, colorectal carcinoma, or pancreatic carcinoma
- Participants in expansion cohorts with NSCLC adenocarcinoma must have progressed after anti-PD-1/PD-L1 therapy unless contraindicated and after therapy for actionable mutations if present, with no more than 2 prior cytotoxic chemotherapy lines for advanced disease
- Participants with pancreatic cancer must have received at least 1 systemic therapy and no more than 2 prior cytotoxic therapies for advanced disease
- Participants with colorectal adenocarcinoma must have progressed during or after standard therapies including fluoropyrimidine-based chemotherapy, oxaliplatin, irinotecan, and targeted treatments for actionable mutations if present, with no more than 2 cytotoxic chemotherapy lines and no more than 4 systemic regimens for advanced disease
- Must have at least one measurable lesion by RECIST v1.1
- Must have available tumor tissue sample or be willing to undergo biopsy for fresh tumor sample
- Must have acceptable physical condition and laboratory results
- Participants of childbearing potential must agree to use effective birth control
- Must not be pregnant, planning pregnancy, or breastfeeding
You will not qualify if you...
- Any medical or psychiatric condition that impairs ability to receive or comply with treatment or study procedures
- Presence of active brain or leptomeningeal metastases
- Prior stem cell, tissue, or solid organ transplant
- Another malignancy requiring treatment within past 2 years except certain low-risk cancers like treated non-melanomatous skin cancer or localized prostate cancer with Gleason score below 6
- Active viral, bacterial, or fungal infection
- Previous treatment with ADAM9 targeted agents
- Prior major surgery, mediastinal or lung radiation, live virus vaccination, systemic cancer treatment, CAR-T therapy, or experimental treatment within 4 weeks before study treatment start
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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
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
9
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