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A Phase 1/1b First-in-Human, Open Label, Dose Escalation and Cohort Expansion Study of MGC026 in Participants With Advanced Solid Tumors
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.
Details
| Lead sponsor | MacroGenics |
|---|---|
| Phase | Phase 1 |
| Status | RECRUITING |
| Enrolment | 250 |
| Start date | 2024-03-06 |
| Completion | 2028-10 |
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
Interventions
- MGC026 Dose Escalation
- MGC026 Dose for Expansion
Primary outcomes
- 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
Countries
United States, Australia, United Kingdom