Trials / Completed
CompletedNCT03761017
MGD019 DART® Protein in Unresectable/Metastatic Cancer
A Phase 1, First-in-Human, Open-Label, Dose Escalation and Cohort Expansion Study of MGD019, a Bispecific DART® Protein Binding PD-1 and CTLA-4 in Patients With Unresectable or Metastatic Neoplasms
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 162 (actual)
- Sponsor
- MacroGenics · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to evaluate the safety and tolerability, pharmacokinetics (PK) pharmacodynamics and preliminary antitumor activity of lorigerlimab. This Phase 1, open-label study will characterize safety, dose-limiting toxicities (DLTs), and maximum tolerated/administered dose (MTD/MAD) of MGD019. Dose escalation will occur in a 3+3+3 design in patients with advanced solid tumors of any histology. Once the MTD/MAD is determined, a Cohort Expansion Phase will be enrolled to further characterize safety and initial anti-tumor activity in patients with specific tumor types anticipated to be sensitive to dual checkpoint blockade.
Conditions
- Squamous Cell Non Small Cell Lung Cancer
- Prostate Cancer Metastatic
- Cutaneous Melanoma
- Colorectal Cancer
- Advanced Cancer
- Solid Tumor, Adult
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Lorigerlimab | Bispecific DART protein binding PD-1 and CTLA-4 |
Timeline
- Start date
- 2018-12-12
- Primary completion
- 2024-08-29
- Completion
- 2025-01-27
- First posted
- 2018-12-03
- Last updated
- 2025-03-06
Locations
39 sites across 5 countries: United States, Bulgaria, Poland, Spain, Ukraine
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03761017. Inclusion in this directory is not an endorsement.