MGD019 DART® Protein in Unresectable/Metastatic Cancer
Public ClinicalTrials.gov record NCT03761017. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT03761017
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 1
- Enrollment
- 162 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Dec 11, 2018
- Primary completion
- Aug 28, 2024
- Completion
- Jan 26, 2025
- Last update posted
- Mar 5, 2025
2018 – 2025
United States locations
- U.S. sites
- 17
- U.S. states
- 7
- U.S. cities
- 14
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of Chicago Medical Center | Chicago | Illinois | 60637 | — |
| Beth Israel Deaconess Medical Center | Boston | Massachusetts | 02215 | — |
| Dana Farber Cancer Institute | Boston | Massachusetts | 02215 | — |
| Massachusetts General Hospital | Boston | Massachusetts | 02215 | — |
| START Midwest | Grand Rapids | Michigan | 49546 | — |
| Oncology Hematology West p.c. dba Nebraska Cancer Specialists | Grand Island | Nebraska | 68803 | — |
| Nebraska Cancer Specialists | Omaha | Nebraska | 68130 | — |
| Providence Portland Medical Center | Portland | Oregon | 97213 | — |
| UPMC Hillman Cancer Center | Camp Hill | Pennsylvania | 17011 | — |
| UPMC Hillman Cancer Center | Carlisle | Pennsylvania | 17015 | — |
| UPMC Hillman Cancer Center | Erie | Pennsylvania | 16505 | — |
| UPMC Pinnacle Harrisburg | Harrisburg | Pennsylvania | 17101 | — |
| UPMC Pinnacle - Community Osteopathic Medical Sciences Pavilion (MSP) | Harrisburg | Pennsylvania | 17109 | — |
| UPMC Pinnacle - Ortenzio Cancer Center (OCC) | Mechanicsburg | Pennsylvania | 17050 | — |
| UPMC Hillman Cancer Center | Pittsburgh | Pennsylvania | 20850 | — |
| UPMC Hillman Cancer Center at UPMC Memorial | York | Pennsylvania | 17408 | — |
| The Sarah Cannon Research Institute / Tennessee Oncology | Nashville | Tennessee | 37203 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 22 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03761017, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Mar 5, 2025 · Synced Sep 11, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT03761017 live on ClinicalTrials.gov.