Study of MGC026 for Advanced Solid Tumors
This study is testing a drug called MGC026 in people with advanced solid tumors, including advanced cancer, metastatic cancer, and specific types like head and neck squamous cell carcinoma and non-small cell lung cancer. The main goal is to understand how safe MGC026 is and what side effects it might cause. Researchers will also look at how the body handles the drug and if it shows any early signs of helping against cancer. You might be able to join if you are an adult (18 or older) with adequate health and if a tumor tissue sample is available. The study will look at how many participants experience side effects throughout the study, for up to 135 weeks.
- Study design
- This is an interventional study with a planned enrollment of 250 participants. It includes a dose escalation part to find the right dose and a dose expansion part to further study that dose.
- What's involved
- You will receive MGC026 through an IV. You may receive up to 35 treatments if you don't have severe side effects and your cancer doesn't worsen. You will be monitored for side effects and cancer progression, and have blood samples taken for routine lab work and research.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be monitored for adverse events throughout the study, for up to 135 weeks.
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NCT06242470
A Study of MGC026 in Participants With Advanced Solid Tumors
Recruiting
PHASE1Ages 18+InterventionalTreatmentMacroGenics
~250 participants
Updated 2026-08-11 on ClinicalTrials.gov
What's tested:MGC026 Dose EscalationMGC026 Dose for Expansion
At a glance
Recruiting sites
12 of 12 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Number of participants with adverse events (AEs) and serious AEs (SAEs), AEs leading to dose delay, AEs leading to dose reduction, AEs leading to treatment discontinuations, AEs meeting criteria for dose limiting toxicity, and AEs of special interest.
Measured over Throughout the study, up to 135 weeks
Conditions
Where it's being run
12 sites across 10 statesTexas2
United Kingdom2
California1
Michigan1
New York1
Oregon1
Utah1
Queensland1
Study leadership
- Denise Casey, MD · STUDY_DIRECTOR · MacroGenics
Who to contact
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Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
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
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.
What this trial measures
- Number of participants with adverse events (AEs) and serious AEs (SAEs), AEs leading to dose delay, AEs leading to dose reduction, AEs leading to treatment discontinuations, AEs meeting criteria for dose limiting toxicity, and AEs of special interest.Throughout the study, up to 135 weeks