New drug MGC026 takes on advanced cancers in first human trial
NCT ID NCT06242470
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
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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 250 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Mar 2024
- Expected to finish
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Oct 2028
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: * 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.
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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 places running it
12 sites in 3 countries. The list below names each one and where it is.
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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: •••••@•••••
Locations
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Austin Health- Olivia Newton John Cancer Center
RECRUITINGHeidelberg, Victoria, 3084, Australia
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ICON Cancer Centre Kurralta Park
RECRUITINGKurralta Park, South Australia, 5037, Australia
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ICON Cancer Centre Wesley
RECRUITINGAuchenflower, Queensland, 4066, Australia
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Oxford University Hospitals NHS Foundation Trust
RECRUITINGOxford, OX3 9DU, United Kingdom
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Providence Cancer Institute
RECRUITINGPortland, Oregon, 97213, United States
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START Midwest
RECRUITINGGrand Rapids, Michigan, 49546, United States
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START Mountain Region
RECRUITINGWest Valley City, Utah, 84119, United States
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START-New York Long Island
RECRUITINGLake Success, New York, 11042, United States
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The Angeles Clinic and Research Institute
RECRUITINGLos Angeles, California, 90025, United States
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The Royal Marsden NHS Foundation Trust
RECRUITINGSutton, SM2 5PT, United Kingdom
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The University of Texas MD Anderson Cancer Center
RECRUITINGHouston, Texas, 77030, United States
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University of Texas Health Science Center at Houston
RECRUITINGHouston, Texas, 77030, United States
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Other studies related to the condition(s) this trial covers.
- Retrospective analysis of pyrotinib in the treatment of HER2-Positive advanced breast cancer previously treated with trastuzumab and pertuzumab
- A decision support tool for pancreatic cancer screening -Aim 2
- A multicenter, Dose-Escalation and expansion phase I/IIa clinical study to evaluate the safety, tolerability, pharmacokinetic characteristics, immunogenicity, and preliminary efficacy of SGT003 in patients with advanced solid tumors
- Ivosidenib plus mFOLFOXIRI and celecoxib as a treatment for BRAF-targeted therapy-refractory BRAF V600E-mutant colorectal cancer patients: a phase II study
- Operationalising multifactorial ovarian cancer risk assessment using the CanRisk tool versus standard practices.
- Can a new drug shrink advanced solid tumors?