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MGC026 Dose Escalation

Phase 1

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

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 Dose Escalation · 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 Dose Escalation

What is MGC026 used for in advanced solid tumors?

MGC026 is an investigational monoclonal antibody being studied for the treatment of advanced solid tumors, including metastatic cancer and various specific cancers such as non-small cell lung cancer, bladder cancer, melanoma, and breast cancer. It is currently in Phase 1 clinical development and is not yet approved by regulatory authorities.

Who is developing MGC026?

MGC026 is being developed by MacroGenics, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol MGNX. The company is conducting a Phase 1 clinical trial to evaluate the safety and efficacy of MGC026 in patients with advanced solid tumors.

What phase is MGC026 in?

MGC026 is in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by the FDA or other regulatory agencies. The ongoing Phase 1 trial is currently recruiting participants to assess the drug's safety, tolerability, and preliminary efficacy in advanced solid tumors.

What clinical trials is MGC026 in?

MGC026 is being evaluated in a single Phase 1 clinical trial with the identifier NCT06242470, titled "A Study of MGC026 in Participants With Advanced Solid Tumors." This trial is actively recruiting up to 250 participants across the United States, Australia, and the United Kingdom.

What types of cancer does the MGC026 trial cover?

The MGC026 Phase 1 trial covers a wide range of advanced solid tumors, including squamous cell carcinoma of the head and neck, non-small cell lung cancer, small-cell lung cancer, bladder cancer, sarcoma, endometrial cancer, melanoma, castration-resistant prostate cancer, cervical cancer, colorectal cancer, gastric cancer, gastro-esophageal cancer, pancreatic cancer, clear cell renal cell carcinoma, hepatocellular carcinoma, platinum-resistant ovarian cancer, breast cancer, ovarian cancer, and esophageal squamous cell cancer.