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New Antibody-Drug conjugate targets Hard-to-Treat cancers

NCT ID NCT06723236

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This early-stage trial tests MGC028, a drug that delivers a cancer-killing agent directly to tumor cells. About 124 adults with advanced lung, bile duct, pancreatic, or colorectal cancers that have stopped responding to standard treatments will receive the drug every three weeks. The main goals are to find safe doses and see if the drug can shrink or stabilize tumors.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
MGC028 (an antibody-drug conjugate targeting ADAM9)
What this could lead to
If it works, this could point toward a new treatment option for several advanced solid tumors that have not responded to standard therapies.
What could go wrong
This is a very early Phase 1 trial with only 124 participants, so the drug may not prove safe or effective. Side effects could be significant, and the cancer may still progress.
Why investors are watching

MacroGenics is testing MGC028, an experimental drug for advanced solid tumors that express a protein called ADAM9. This is a first-in-human phase 1 study, so the main goal is safety and dosing, with early signs of tumor shrinkage as a secondary readout. For a small company, this early data will show whether the drug is worth advancing and could shape its pipeline value.

If it works: If MGC028 proves tolerable and shows signs of controlling tumor growth, MacroGenics could move it into later-stage testing. That would give the company a new candidate in oncology and a reason for investors to follow its progress.

If it fails: Phase 1 trials fail often, and side effects or lack of response could halt development. A poor result would leave MacroGenics with a setback and no clear path for this drug.

AI-written from the trial record. Speculative, and not investment advice.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 124 people

The number the study aims to enrol. It can still change while the study runs.

Started

Feb 2025

Expected to finish

Apr 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 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 Criteria: * 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.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    7 sites. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • Dana Farber/Harvard Cancer Center

    RECRUITING

    Boston, Massachusetts, 02115, United States

  • Icahn School of Medicine at Mt. Sinai

    RECRUITING

    New York, New York, 10029, United States

  • Mass General Brigham

    RECRUITING

    Boston, Massachusetts, 02114, United States

  • South Texas Accelerated Research Therapeutics (START) Midwest

    RECRUITING

    Grand Rapids, Michigan, 49546, United States

  • South Texas Accelerated Research Therapeutics (START) Mountain Region

    RECRUITING

    West Valley City, Utah, 84119, United States

  • South Texas Accelerated Research Therapeutics (START) San Antonio

    RECRUITING

    San Antonio, Texas, 78229, United States

  • UCSF - Helen Diller Family Cancer Center

    RECRUITING

    San Francisco, California, 94115, United States

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