New drug MGC026 takes on advanced cancers in first human trial

NCT ID NCT06242470

What the study statuses mean

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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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Aug 12, 2026 · Updated 2 times

Summary

This early-phase trial tests MGC026, a biologic drug given by IV, in 250 adults with advanced solid tumors that have not responded to standard treatments. The study has two parts: first, finding a safe dose, then expanding to see if the drug shrinks tumors. Participants receive up to 35 doses if their cancer does not worsen and side effects are manageable.

What this could mean

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

Active substance
MGC026 (a biologic drug given by IV infusion)
What this could lead to
If it works, this could point toward a new treatment option for several advanced cancers that have stopped responding to other therapies.
What could go wrong
This is a very early Phase 1 trial, so the main goal is safety, not proof of effectiveness. Many drugs fail at this stage, and side effects could be significant.

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 250 people

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

Started

Mar 2024

Expected to finish

Oct 2028

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: * Adults ≥ 18 years old, able to provide informed consent * Adequate performance and laboratory parameters * Availability of archival or formalin-fixed paraffin-embedded tumor tissue sample. Participants may undergo a fresh tumor biopsy to obtain a specimen for testing if an archival tumor sample is not available. Participants with no available archival tissue sample who cannot safely undergo a fresh biopsy as determined by consultation between the sponsor and investigator are eligible * Unresectable, locally advanced or metastatic solid tumors including: squamous cell cancer (SCC) of the head and neck, esophageal SCC, squamous and non-squamous non-small cell lung cancer, small cell lung cancer, bladder cancer, sarcoma, endometrial cancer, melanoma, castration resistant prostate cancer, breast cancer, ovarian cancer, cervical cancer, colorectal cancer gastric or gastroesophageal cancer, pancreatic carcinoma, clear cell renal cell cancer or hepatocellular cancer. * Measurable disease per RECIST v1.1. Participants with metastatic CRPC without measurable disease are eligible. * Must be willing to use highly effective methods of birth control from the time of consent through 7 months after discontinuation of MGC026. * Not 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. * Another cancer that required treatment within the past 2 years, with the exception of those with low risk of cancer spreading or death such as adequately treated non melanomatous skin cancer, localized prostate cancer (Gleason Score \< 6), or carcinoma in situ. * Patients with history of prior central nervous system (CNS) metastasis must have been treated, be asymptomatic, and not have concurrent treatment for CNS disease, progression of CNS metastases on magnetic resonance imaging, computed tomography or positron emission tomography, or history of leptomeningeal disease or cord compression at the time of enrollment. * Treatment with surgery, systemic cancer therapy, immunotherapy, chimeric antigen receptor-T therapy, or anti-hormonal within protocol specified intervals. * Prior treatment with any B7-H3 targeted agent for cancer or any ADC with a topoisomerase payload. * Prior autologous or allogeneic stem cell or solid organ transplant. * Clinically significant cardiovascular, pulmonary, or gastrointestinal disorders. * Active viral, bacterial, or systemic fungal infection requiring parenteral treatment within 1 week of first study drug administration. * Known history of hepatitis B or C infection or known positive test for hepatitis B surface antigen or core antigen, or hepatitis C polymerase chain reaction. * Known positive testing for human immunodeficiency virus or history of acquired immune deficiency syndrome. * History of primary immunodeficiency. * Major trauma or major surgery within 4 weeks of first study drug administration. * Known hypersensitivity to recombinant proteins.

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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

    12 sites in 3 countries. 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

  • Austin Health- Olivia Newton John Cancer Center

    RECRUITING

    Heidelberg, Victoria, 3084, Australia

  • ICON Cancer Centre Kurralta Park

    RECRUITING

    Kurralta Park, South Australia, 5037, Australia

  • ICON Cancer Centre Wesley

    RECRUITING

    Auchenflower, Queensland, 4066, Australia

  • Oxford University Hospitals NHS Foundation Trust

    RECRUITING

    Oxford, OX3 9DU, United Kingdom

  • Providence Cancer Institute

    RECRUITING

    Portland, Oregon, 97213, United States

  • START Midwest

    RECRUITING

    Grand Rapids, Michigan, 49546, United States

  • START Mountain Region

    RECRUITING

    West Valley City, Utah, 84119, United States

  • START-New York Long Island

    RECRUITING

    Lake Success, New York, 11042, United States

  • The Angeles Clinic and Research Institute

    RECRUITING

    Los Angeles, California, 90025, United States

  • The Royal Marsden NHS Foundation Trust

    RECRUITING

    Sutton, SM2 5PT, United Kingdom

  • The University of Texas MD Anderson Cancer Center

    RECRUITING

    Houston, Texas, 77030, United States

  • University of Texas Health Science Center at Houston

    RECRUITING

    Houston, Texas, 77030, United States

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