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Advanced Cancer / Advanced Solid Tumor / MGC026 Dose for Expansion · Phase 1 Trial
ClinicalTrials.gov · August 11, 2026
Early or partial results. Treat as a signal, not a conclusion.
This is a Phase 1 registry record for a planned dose-escalation and expansion study of MGC026, a novel biologic agent, in participants with advanced solid tumors. No efficacy or safety results are reported in this record; the study is actively recruiting and designed to evaluate safety, tolerability, pharmacokinetics, and preliminary antitumor activity.
Phase 1, Interventional, Non Randomized, Sequential, Open label, Treatment purpose. Advanced Solid Tumor, Advanced Cancer, Metastatic Cancer, Squamous Cell Carcinoma of Head and Neck, Non Small Cell Lung Cancer, Small-cell Lung Cancer, Bladder…; age from 18 Years. Intervention: Cohort 1; Cohort 2; Cohort 3; Cohort 4; Cohort 5; Cohort 6; Expansion cohort 1; Expansion cohort 2; Expansion cohort 3; Expansion cohort 4; Expansion Cohort 5; Expansion Cohort 6. n = 250. 12 sites: United States, Australia, United Kingdom.
This is a Phase 1 registry record for a planned dose-escalation and expansion study of MGC026, a novel biologic agent, in participants with advanced solid tumors. No efficacy or safety results are reported in this record; the study is actively recruiting and designed to evaluate safety, tolerability, pharmacokinetics, and preliminary antitumor activity.
No efficacy or safety results are reported in this registry record; the study is actively recruiting. Primary endpoints are safety and tolerability only; antitumor activity is described as preliminary and not a primary outcome.
Clinicians should note that this is a first-in-human Phase 1 study with no posted results. Enrollment is ongoing. Any future decisions to evaluate MGC026 in clinical practice will depend on completion of this dose-escalation phase and demonstration of acceptable safety and preliminary efficacy.
Phase 1 dose-escalation study of a novel biologic in early-stage development; no results are posted in this registry record, only planned study design and safety endpoints.
As stated by the source record.
Quoted from the source exactly as published.
Clinicians should note that this is a first-in-human Phase 1 study with no posted results. Enrollment is ongoing. Any future decisions to evaluate MGC026 in clinical practice will depend on completion of this dose-escalation phase and demonstration of acceptable safety and preliminary efficacy.
Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.
What is missing. This record has no key findings. That is a gap in the analysis, not a judgement about the study.
Registry record from ClinicalTrials.gov (NCT06242470). This is a study registration, not published results. Lead sponsor: MacroGenics. Recruitment status: RECRUITING. Phase: PHASE1. Study type: INTERVENTIONAL. Enrollment: 250 participants (ESTIMATED). Conditions: Advanced Solid Tumor, Advanced Cancer, Metastatic Cancer, Squamous Cell Carcinoma of Head and Neck, Non Small Cell Lung Cancer, Small-cell Lung Cancer, Bladder Cancer, Sarcoma, Endometrial Cancer, Melanoma, Castration Resistant Prostatic Cancer, Cervical Cancer, Colorectal Cancer, Gastric Cancer, Gastro-esophageal Cancer, Pancreas Cancer, Clear Cell Renal Cell Carcinoma, Hepatocellular Carcinoma, Platinum-resistant Ovarian Cancer, Breast Cancer, Ovarian Cancer, Esophageal Squamous Cell Cancer (SCC). Interventions: BIOLOGICAL: MGC026 Dose Escalation; BIOLOGICAL: MGC026 Dose for Expansion. Primary outcome 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. Brief summary: The study is designed to understand the safety, tolerability, pharmacokinetics, immunogenicity, and preliminary antitumor activity of MGC026 in participants with relapsed or refractory, unresectable, locally advanced or metastatic solid tumors The study has a dose escalation portion and a cohort expansion portion of the study. Participants will receive MGC026 by intravenous (IV) infusion. The dose of MGC026 will be assigned at the time of enrollment. Participants may receive up to 35 treatments if there are no severe side effects and as long as the cancer does not get worse. Participants will be monitored for side effects, and progression of cancer, have blood samples collected for routing laboratory work, and blood samples collected for research purposes.
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