New Antibody-Drug conjugate put to the test against Hard-to-Treat cancers

NCT ID NCT07822399

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 16, 2026 · Last updated Sep 17, 2026 · Updated 1 time

Summary

Researchers are running a first-in-human study of MGC030, an antibody-drug conjugate, in people with advanced solid tumors that have come back or stopped responding to standard treatment. The trial includes participants with urothelial, colorectal, gastric, gastroesophageal, esophageal, or pancreatic cancer. The main goals are to find out what side effects MGC030 causes and whether it can shrink tumors or slow their growth. Participants receive the study drug every three weeks and have regular blood tests, heart and lung checks, and tumor scans.

What this could mean

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

Active substance
an antibody-drug conjugate called MGC030
What this could lead to
If MGC030 works, it could offer a new treatment option for several hard-to-treat advanced cancers, including urothelial, gastric, esophageal, colorectal, and pancreatic tumors.
What could go wrong
This is a first-in-human Phase 1 study, so researchers mainly want to learn about safety and dosing. The drug may cause serious side effects, and it may not shrink tumors or help participants live longer.

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 314 people

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

Expected to start

Sep 2026

An estimate. Start dates often move.

Expected to finish

Mar 2029

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 cohorts must have histologically proven unresectable, locally advanced or metastatic solid tumor limited to one of the following types: urothelial cancer, colorectal cancer (CRC), gastric or gastroesophageal junction (GEJ) cancer, esophageal cancer, 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 histologically proven, unresectable, locally advanced or metastatic solid tumors * Urothelial cancer with progression following platinum-containing chemotherapy for metastatic or locally advanced/unresectable cancer, or within 12 months from completion of neo-adjuvant or adjuvant platinum-containing chemotherapy for localized muscle-invasive cancer. * Gastric/GEJ carcinoma with progression during or following at least 1 systemic therapy. * Esophageal cancer with progression during or following at least 1 systemic therapy. * CRC with progression during or following treatment with at least 2 prior lines of systemic therapy (containing a fluoropyrimidine plus a platinum analogue and/or irinotecan) for metastatic disease. * CRC harboring an activating EGFR mutation must have progressed during or following at least one EGFR targeted therapy, if available. * Participants should have received no more than 4 prior lines of systemic therapy for advanced or metastatic disease. * Pancreatic cancer with progression during or following at least 1 systemic therapy. Participants should have received no more than 2 prior lines of cytotoxic chemotherapy 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. * History of primary immunodeficiency. * Active viral, bacterial, or fungal infection * Prior treatment with Topoisomerase 1-based ADCs 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

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  1. The study's own enquiry address

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

  2. 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 ↗

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Contacts and locations

Study contacts

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