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MGC026

Phase 1

Advanced Solid Tumor | Monoclonal antibody | Oncology |MacroGenics, Inc.|Last Updated: Aug 11, 2026

Target and mechanism

Molecular targetB7-H3
ModalityMonoclonal antibody

Also known as MGC026 Dose Escalation

Success Probability

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Market & Valuation

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Trial Design

CONTROLLEDDMC
Total Trials1
Total Enrollment250

FDA Designations

No designations recorded

Clinical trial landscape

MGC026 · 1 trial · 22 indications

Phase 1 1
NCT06242470A Study of MGC026 in Participants With Advanced Solid TumorsAdvanced Solid Tumor
RECRUITING250 Analytics
PHASE1RECRUITING
A Study of MGC026 in Participants With Advanced Solid Tumors
Advanced Solid TumorUnlock trial analytics

Study Endpoints

Primary Endpoints

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

Secondary Endpoints

Overall response rate in advanced solid tumors
Throughout the study, up to 135 weeks
Duration of response (DoR) in advanced solid tumors
Throughout the study, up to 135 weeks
ORR rate in metastatic castration resistant prostate cancer (mCRPC)
Throughout the study, up to 135 weeks
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelSEQUENTIAL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Cohort 1EXPERIMENTALMGC026 is a topoisomerase 1 inhibitor (TOP1i)-based ADC that targets B7-H3 administered IV every 3 weeks.
Cohort 2EXPERIMENTAL -
Cohort 3EXPERIMENTAL -
Cohort 4EXPERIMENTAL -
Cohort 5EXPERIMENTAL -
Cohort 6EXPERIMENTAL -
Expansion cohort 1EXPERIMENTAL -
Expansion cohort 2EXPERIMENTAL -
Expansion cohort 3EXPERIMENTAL -
Expansion cohort 4EXPERIMENTAL -
Expansion Cohort 5EXPERIMENTAL -
Expansion Cohort 6EXPERIMENTAL -

Interventions

NameTypeDescription
MGC026 Dose EscalationBIOLOGICALEscalating doses of MGC026
MGC026 Dose for ExpansionBIOLOGICALMGC026 recommended dose for expansion
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites12

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 arc...

Countries:United StatesAustraliaUnited Kingdom
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Competitive Landscape -Other Solid Tumors 9 trials (matched to "Advanced Solid Tumor")

Recent Changes (Last 90 Days)

LOWAug 11, 2026NCT06242470lastUpdatePostDate: changed
LOWAug 11, 2026NCT06242470lastUpdatePostDate: changed

Frequently asked questions about MGC026

What is MGC026 used for?

MGC026 is an investigational monoclonal antibody being studied in adults with advanced solid tumors. The Phase 1 trial enrolls patients across many cancer types, including non-small cell lung cancer, small-cell lung cancer, head and neck squamous cell carcinoma, bladder cancer, melanoma, gastric cancer, pancreatic cancer, and ovarian cancer.

What does MGC026 target?

MGC026 targets B7-H3, a protein expressed on the surface of tumor cells and involved in immune regulation. By binding B7-H3, this monoclonal antibody is designed to act against cancer cells that express the target. It is being developed as an oncology therapeutic for advanced solid tumors.

Who is developing MGC026?

MGC026 is being developed by MacroGenics, Inc., which trades under the ticker MGNX. The company is sponsoring the clinical program evaluating this monoclonal antibody in patients with advanced solid tumors.

What phase is MGC026 in?

MGC026 is in Phase 1 clinical development. It is an investigational agent and has not been approved by the FDA. The ongoing Phase 1 study is designed to evaluate the drug in participants with advanced solid tumors, with enrollment of approximately 250 patients.

What clinical trials is MGC026 in?

MGC026 is being evaluated in one active clinical trial, NCT06242470, titled A Study of MGC026 in Participants With Advanced Solid Tumors. The trial is currently recruiting and plans to enroll about 250 participants across sites in the United States, Australia, and the United Kingdom.

Is MGC026 the same as MGC026 Dose Escalation?

Yes, MGC026 Dose Escalation is another name used for MGC026, the monoclonal antibody developed by MacroGenics. Both names refer to the same investigational drug candidate being studied in the Phase 1 trial NCT06242470 for advanced solid tumors.