New Antibody-Drug conjugate put to the test against Hard-to-Treat cancers
NCT ID NCT07822399
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
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 314 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Sep 2026
An estimate. Start dates often move.
- Expected to finish
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Mar 2029
An estimate. End dates often move.
- Lead sponsor
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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
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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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
Only the study team decides who joins. These are the ways to reach them.
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The study's own enquiry address
This study publishes an address for enquiries. See it below .
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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
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Study contacts
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Contact
Email: •••••@•••••
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