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MGD019 DART® Protein in Unresectable/Metastatic Cancer

NCT03761017 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 162

Last updated 2025-03-06

No results posted yet for this study

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

Interventions

BIOLOGICAL

Lorigerlimab

Bispecific DART protein binding PD-1 and CTLA-4

Sponsors & Collaborators

Principal Investigators

  • Denise Casey, MD · MacroGenics

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-12-12
Primary Completion
2024-08-29
Completion
2025-01-27
FDA Drug
Yes

Countries

  • United States
  • Bulgaria
  • Poland
  • Spain
  • Ukraine

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03761017 on ClinicalTrials.gov