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A Study of MGD013 in Patients With Unresectable or Metastatic Neoplasms

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ClinicalTrials.gov Identifier: NCT03219268
Recruitment Status : Recruiting
First Posted : July 17, 2017
Last Update Posted : March 14, 2018
Information provided by (Responsible Party):

Brief Summary:
The primary goal of this Phase 1 study is to characterize the safety and tolerability of MGD013 and establish the maximum tolerated dose (MTD) of MGD013. Pharmacokinetics (PK), immunogenicity, pharmacodynamics (PD), and the anti-tumor activity of MGD013 will also be assessed.

Condition or disease Intervention/treatment Phase
Advanced Solid Tumors Hematologic Neoplasms Biological: MGD013 Phase 1

Detailed Description:

This is a Phase 1, open-label, dose escalation and cohort expansion study designed to characterize the safety, tolerability, PK, PD, immunogenicity, and preliminary antitumor activity of MGD013 administered by IV infusion on every 2 weeks. The study consists of a Dose Escalation Phase to determine the MTD or maximum administered dose (MAD) of MGD013 if no MTD is defined, followed by a Cohort Expansion Phase to further define the safety and initial antitumor activity of MGD013 with the dose established in the Dose Escalation Phase.

In the Dose Escalation Phase, MGD013 will be evaluated in sequential escalating flat doses in successive cohorts of 1 to 6 patients each. Upon completion of the Dose Escalation Phase, a Cohort Expansion Phase will be initiated at the MTD/MAD.

Patients with unresectable, locally advanced or metastatic solid tumors of any histology will be enrolled in the Dose Escalation Phase. The Cohort Expansion Phase will be limited to selected cohorts of patients with unresectable, locally advanced or metastatic solid tumors or hematologic malignancies for whom there is no available therapy likely to confer clinical benefit.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 131 participants
Intervention Model: Single Group Assignment
Intervention Model Description: Dose escalation followed by Cohort Expansion Phase at the MTD.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1, First-in-Human, Open-Label, Dose Escalation Study of MGD013, A Bispecific DART® Protein Binding PD-1 and LAG-3 in Patients With Unresectable or Metastatic Neoplasms
Actual Study Start Date : August 23, 2017
Estimated Primary Completion Date : February 2020
Estimated Study Completion Date : August 2022

Arm Intervention/treatment
Experimental: MGD013
MGD013 administered IV once every 2 weeks for up to 12 8-week cycles
Biological: MGD013
Anti-PD-1, anti-LAG-3 bispecific DART protein

Primary Outcome Measures :
  1. Incidence of Treatment-Emergent Adverse Events as assessed by CTCAE v4.03 [ Time Frame: 24 months ]


    Safety is based on evaluation of adverse events (AEs) and serious adverse events (SAEs) from the time of study drug administration through the End of Study visit.

  2. Maximum Tolerated Dose [ Time Frame: 24 months ]
    maximum tolerated or maximum administered dose of MGD013

Secondary Outcome Measures :
  1. Area Under the Plasma Concentration versus Time Curve (AUC) of MGD013 [ Time Frame: 24 months ]

  2. Maximum Plasma Concentration (Cmax) of MGD013 [ Time Frame: 24 months ]

  3. Time to reach maximum (peak) plasma concentration (Tmax) of MGD013 [ Time Frame: 24 months ]

  4. Trough plasma concentration (Ctrough) of MGD013 [ Time Frame: 24 months ]

  5. Total body clearance of the drug from plasma (CL) of MGD013 [ Time Frame: 24 months ]

  6. Apparent volume of distribution at steady state (Vss) of MGD013 [ Time Frame: 24 months ]

  7. Terminal half-life (t1/2) of MGD013 [ Time Frame: 24 months ]

  8. Percent of patients with anti-drug antibody [ Time Frame: 24 months ]

  9. Efficacy: Preliminary anti-tumor activity of MGD013 [ Time Frame: 36 months ]
    Preliminary anti-tumor activity of MGD013

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Histologically proven, locally advanced unresectable or metastatic solid tumors or hematologic malignancies for whom no approved therapy with demonstrated clinical benefit is available or standard treatment was declined.
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  • Life expectancy ≥ 12 weeks
  • Measurable disease
  • Tissue specimen available for retrospective analysis of PD-1, PD-L1, LAG-3, and MHC-II expression
  • Acceptable laboratory parameters

Exclusion Criteria:

  • Symptomatic central nervous system (CNS) metastases or primary CNS lymphoma
  • History of allogeneic bone marrow, stem-cell, or solid organ transplant
  • History of known or suspected autoimmune disease with the specific exceptions of vitiligo, resolved childhood atopic dermatitis, psoriasis not requiring systemic treatment (within the past 2 years), and patients with a history of Grave's disease that are now euthyroid clinically and by laboratory testing.
  • Treatment with any systemic anti-neoplastic therapy, or investigational therapy within the 4 weeks prior to the initiation of study drug.
  • Treatment with radiation therapy within 2 weeks prior to the initiation of study drug.
  • Clinically significant cardiovascular disease
  • Clinically significant pulmonary compromise, including a requirement for supplemental oxygen use to maintain adequate oxygenation.
  • Clinically significant gastrointestinal disorders.
  • Evidence of active viral, bacterial, or systemic fungal infection requiring parenteral treatment within 7 days prior to the initiation of study drug.
  • Known history of positive testing for human immunodeficiency virus or history of acquired immune deficiency syndrome.
  • Known history of hepatitis B or hepatitis C infection or known positive test for hepatitis B surface antigen, hepatitis B core antigen, or hepatitis C polymerase chain reaction (PCR)
  • Vaccination with any live virus vaccine within 4 weeks prior to the initiation of study drug administration. Inactivated annual influenza vaccination is allowed
  • Dementia or altered mental status that would preclude understanding and rendering of informed consent

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03219268

Contact: Lisa Adali-Piston 240 552-8029 adalipistonl@macrogenics.com

United States, California
UCLA Hematology & Oncology Clinic Recruiting
Los Angeles, California, United States, 90095
Contact: Maria Casado    310-794-6913    MCasado@mednet.ucla.edu   
Principal Investigator: Bartosz Chmielowski, MD         
United States, Florida
Florida Cancer Specialists & Research Institute Recruiting
Sarasota, Florida, United States, 34232
Contact: Kris Howard    941-377-9993    KHoward@flcancer.com   
Principal Investigator: Manish Patel, MD         
United States, Illinois
University of Chicago Medicine Recruiting
Chicago, Illinois, United States, 60637
Contact: Ekaterini Andreatos    773-702-1649    eandreatos@medicine.bsd.uchicago.edu   
Principal Investigator: Jason Luke, MD         
United States, Maryland
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins Recruiting
Baltimore, Maryland, United States, 21287
Contact: Chelsea Miralles    410-955-9923    cmirall1@jhmi.edu   
Principal Investigator: Roisin Connolly, MD         
United States, Tennessee
Sarah Cannon Research Institute Recruiting
Nashville, Tennessee, United States, 37203
Contact: Ashley Denning    615-329-7274    Ashley.Denning@sarahcannon.com   
Principal Investigator: Erika Hamilton, MD         
United States, Texas
The University of Texas M.D. Anderson Cancer Center Not yet recruiting
Houston, Texas, United States, 77030
Contact: Jisha Mathews    713-745-9919    JMathews2@mdanderson.com   
Principal Investigator: George Blumenschein, MD         
Sponsors and Collaborators
Study Director: Sadhna Shankar, MD, MPH MacroGenics

Responsible Party: MacroGenics
ClinicalTrials.gov Identifier: NCT03219268     History of Changes
Other Study ID Numbers: CP-MGD013-01
First Posted: July 17, 2017    Key Record Dates
Last Update Posted: March 14, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Hematologic Neoplasms
Neoplasm Metastasis
Neoplasms by Site
Hematologic Diseases
Neoplastic Processes
Pathologic Processes