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 : July 15, 2020
|Condition or disease||Intervention/treatment||Phase|
|Advanced Solid Tumors Hematologic Neoplasms Gastric Cancer Ovarian Cancer GastroEsophageal Cancer HER2-positive Breast Cancer HER2-positive Gastric Cancer DLBCL||Biological: MGD013 Biological: MGD013 in combination with margetuximab||Phase 1|
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 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. Two additional cohorts will enroll patients with gastric/gastroesophageal cancer or epithelial ovarian cancer, with MGD013 given every 3 weeks.
A separate cohort will evaluate the combination of MGD013 with margetuximab (anti-HER2 monoclonal antibody) in approximately 99 patients, in subgroups with HER2-positive gastric or gastroesophageal cancer, HER2-positive breast cancer, and any other HER2-positive cancer.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||445 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||Dose escalation followed by Cohort Expansion Phase at the MTD.|
|Masking:||None (Open Label)|
|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 18, 2017|
|Estimated Primary Completion Date :||July 2021|
|Estimated Study Completion Date :||August 2022|
MGD013 administered IV once every 2 or 3 weeks for up to 96 weeks
Anti-PD-1, anti-LAG-3 bispecific DART protein
Experimental: MGD013 plus margetuximab
MGD013 administered in combination with margetuximab IV once every 3 weeks for up to 32 3-week cycles
Anti-PD-1, anti-LAG-3 bispecific DART protein
Biological: MGD013 in combination with margetuximab
Anti-PD-1, anti-LAG-3 bispecific DART protein plus anti-HER2 monoclonal antibody
Other Name: MGAH22
- Incidence of Treatment-Emergent Adverse Events as assessed by CTCAE v4.03 (MGD013 monotherapy) [ 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.
- Maximum Tolerated Dose [ Time Frame: 24 months ]maximum tolerated or maximum administered dose of MGD013
- Area Under the Plasma Concentration versus Time Curve (AUC) of MGD013 and MGD013 plus margetuximab [ Time Frame: 24 months ]AUC
- Maximum Plasma Concentration (Cmax) of MGD013 and MGD013 plus margetuximab [ Time Frame: 24 months ]Cmax
- Time to reach maximum (peak) plasma concentration (Tmax) of MGD013 and MGD013 plus margetuximab [ Time Frame: 24 months ]Tmax
- Trough plasma concentration (Ctrough) of MGD013 and MGD013 plus margetuximab [ Time Frame: 24 months ]Ctrough
- Total body clearance of the drug from plasma (CL) of MGD013 and MGD013 plus margetuximab [ Time Frame: 24 months ]CL
- Apparent volume of distribution at steady state (Vss) of MGD013 and MGD013 plus margetuximab [ Time Frame: 24 months ]Vss
- Terminal half-life (t1/2) of MGD013 and MGD013 plus margetuximab [ Time Frame: 24 months ]t1/2
- Percent of patients with anti-drug antibody [ Time Frame: 24 months ]immunogenicity
- Incidence of Treatment-Emergent Adverse Events as assessed by CTCAE v4.03 (MGD013 plus margetuximab) [ Time Frame: 24 months ]Safety
- Efficacy: Preliminary anti-tumor activity of MGD013 and MGD013 plus margetuximab [ Time Frame: 36 months ]Preliminary anti-tumor activity of MGD013 and MGD013 plus margetuximab
- Overall survival [ Time Frame: Up to 2 years after end of treatment visit ]Time from start of treatment to death
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: Nadia Salem||202-834-0910||salemn@Macrogenics.com|
|Contact: Janine Koucheki||(240) email@example.com|
|Principal Investigator:||Bradley Sumrow, MD||MacroGenics|