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A Study of MGC028 for Advanced Solid Tumors

This study is testing a new treatment called MGC028 for adults with advanced solid tumors, specifically non-small cell lung cancer (adenocarcinoma), cholangiocarcinoma, colorectal cancer, or pancreatic cancer. MGC028 is an antibody-drug conjugate, which means it's designed to deliver a drug directly to cancer cells that have a specific marker called ADAM9. The main goals are to understand the safety of MGC028, what side effects it might cause, and to find the best dose. Researchers also want to see if MGC028 can shrink tumors or stop them from growing. You might be able to join if your cancer has not responded to standard treatments or if there are no standard treatments available.

Study design
This is an interventional study planning to enroll 124 participants. The phase of the study is not specified.
What's involved
You would undergo screening to see if you qualify. If eligible, you would receive MGC028 treatment initially every 3 weeks.
Compensation
Not stated in the trial record.
Follow-up
Your safety will be monitored throughout the study treatment and for up to 25 months after treatment.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06723236

A Study of MGC028 in Participants With Advanced Solid Tumors

Recruiting
PHASE1Ages 18+InterventionalTreatment
MacroGenics
~124 participants
Updated 2026-04-27 on ClinicalTrials.gov
What's tested:MGC028

At a glance

Recruiting sites
7 of 7 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Number and Types of Adverse Events (AEs) in Participants Receiving MGC028
Measured over Throughout the study treatment and safety follow up period, up to 25 months

Conditions

Advanced Solid Tumors
NSCLC Adenocarcinoma
Cholangiocarcinoma
Pancreatic Carcinoma
Colorectal Carcinoma

Explore related trials

CholangiocarcinomaColorectal CarcinomaLung Non-Small Cell CarcinomaPancreatic CarcinomaSolid Neoplasm

Where it's being run

7 sites across 6 states
Massachusetts2
California1
Michigan1
New York1
Texas1
Utah1

Study leadership

  • Pepi Pencheva, M.D. · STUDY_DIRECTOR · MacroGenics

Who to contact

Global Trial Manager
[email protected]
301-251-5172
Email the study team

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Do you actually qualify for this trial?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

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Eligibility criteria

Inclusion

Participants in dose escalation or supplemental cohorts must have histologically proven unresectable, locally advanced or metastatic solid tumor limited to one of the following types: NSCLC adenocarcinoma, cholangiocarcinoma, colorectal carcinoma (CRC), or pancreatic carcinoma that is refractory to standard therapy, or for which standard therapy does not exist, has proven to be intolerable, or has been refused by the participant.
Participants in expansion cohorts must have either
NSCLC adenocarcinoma with
progression on or following anti-PD-1/PD-L1 inhibitor, unless contraindicated
progression on or following therapy for actionable mutations (e.g. EGFR or ALK mutations), if present
no more than 2 prior lines of cytotoxic chemotherapy for advanced or metastatic disease.
Pancreatic cancer
following at least 1 systemic therapy
no more than 2 prior lines of cytotoxic therapy for advanced or metastatic disease.
Colorectal adenocarcinoma with
Progression during or following standard therapy with a fluoropyrimidine-based chemotherapy, oxaliplatin and irinotecan unless contraindicated, refused or unavailable
Progression after prior targeted treatment for CRC with actionable mutations such as EGFR, KRAS, BRAF and MSI- H/dMMR, if present.
No more that 2 lines of cytotoxic chemotherapy for advanced or metastatic disease
No more than 4 lines of systemic regimens for advanced or metastatic disease
Participants must have at least one lesion that meets the definition of measurable disease by RECIST v1.1.
Participants must have an available archival or formalin-fixed paraffin-embedded tumor tissue or be willing to undergo a biopsy procedure to obtain a fresh tumor sample.
Participants have acceptable physical condition and laboratory values.
Participants of childbearing potential must agree to use highly effective methods of birth control.
Participants must not be pregnant, planning to be pregnant, or breastfeeding.

Exclusion

Any underlying medical or psychiatric condition impairing participant's ability to receive, tolerate, or comply with the planned treatment or study procedures.
Active brain metastases or leptomeningeal metastases.
Prior stem cell, tissue, or solid organ transplant.
Another malignancy that required treatment within the past 2 years, with the exception of those with a negligible risk of metastasis or death such as adequately treated non-melanomatous skin cancer, localized prostate cancer (Gleason Score \< 6), or carcinoma in situ.
Active viral, bacterial, or fungal infection
Prior treatment with ADAM9 targeted agent for cancer.
Prior treatment with major surgery, mediastinal or lung radiation, vaccination with live virus vaccines, systemic cancer treatment, chimeric antigen receptor (CAR)-T cell therapy, or experimental treatment within 4 weeks of the start of study treatment.

What this trial measures

  • Number and Types of Adverse Events (AEs) in Participants Receiving MGC028Throughout the study treatment and safety follow up period, up to 25 months

    Types of AEs include Serious Adverse Events (SAEs), and AEs Leading to Treatment Delay or Discontinuation or Dose Reduction, dose limiting toxicities, and AEs of Special Interest. Observation of side effects determines the highest safe dose for further study