A Study of MGD013 in Patients With Unresectable or Metastatic Neoplasms
NCT ID: NCT03219268
Last Updated: 2023-12-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
277 participants
INTERVENTIONAL
2017-08-18
2023-02-08
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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Tebotelimab: 1 mg
tebotelimab 1 mg
1 mg IV every other week
Tebotelimab 3 mg
tebotelimab 3 mg
3 mg IV every other week
Tebotelimab: 10 mg
tebotelimab 10 mg
10 mg IV every other week
Tebotelimab: 30 mg
tebotelimab 30 mg
30 mg IV every other week
Tebotelimab: 120 mg
tebotelimab 120 mg
120 mg IV every other week
Tebotelimab: 400 mg
tebotelimab 400 mg
400 mg IV every other wee
Tebotelimab: 600 mg
tebotelimab 600 mg
600 mg IV every other week
Tebotelimab: 800 mg
tebotelimab 800 mg
800 mg IV every other week
Tebotelimab: 1200 mg
tebotelimab 1200 mg
1200 mg IV every other week
Combination cohort 1
Tebotelimab and margetuximab
tebotelimab 300 mg
300 mg IV every other wee
margetuximab
15 mg/kg IV every 3 weeks
Combination Cohort 2
Tebotelimab and margetuximab
tebotelimab 600 mg
600 mg IV every other week
margetuximab
15 mg/kg IV every 3 weeks
Monotherapy Cohort Expansion
Monotherapy expansion at 600 mg
tebotelimab 600 mg
600 mg IV every other week
Interventions
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tebotelimab 1 mg
1 mg IV every other week
tebotelimab 3 mg
3 mg IV every other week
tebotelimab 10 mg
10 mg IV every other week
tebotelimab 30 mg
30 mg IV every other week
tebotelimab 120 mg
120 mg IV every other week
tebotelimab 300 mg
300 mg IV every other wee
tebotelimab 400 mg
400 mg IV every other wee
tebotelimab 600 mg
600 mg IV every other week
tebotelimab 800 mg
800 mg IV every other week
tebotelimab 1200 mg
1200 mg IV every other week
margetuximab
15 mg/kg IV every 3 weeks
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
HER2+ Cohort:
\- Locally advanced or metastatic HER2+ locally advanced or metastatic solid tumors, regardless of organ of origin.
i. The cancer must have progressed following standard therapy, or has progressed during or after HER2-directed therapy if approved and available for patients with HER2+ breast, gastric, or gastroesophageal junction cancer.
ii. History of HER2 positivity defined as 3+ by IHC or 2+ by Immunohistochemistry (IHC) in combination with in situ hybridization (ISH) positivity most recent tumor biopsy.
* All patients in the HER2+ cohort must be willing to provide consent for a baseline and on-treatment tumor biopsy during the screening period and within 14 days prior to Cycle 3 Day 1. Exceptions may be made based on a medical contraindication at the discretion of the Sponsor's Medical Monitor. This requirement will be discontinued after an adequate number of samples are collected, as determined by the Sponsor.
Exclusion Criteria
* 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 chemotherapy within 3 weeks prior to the initiation of study drug; treatment with biologics or investigational therapy within the 4 weeks prior to the initiation of study drug.
* Major surgery within 4 weeks prior to the initiation of study drug.
* Prior treatment with combination of monoclonal antibodies against PD-1 and LAG-3 (Cohort Expansion only).
* Treatment with radiation therapy within 2 weeks prior to the initiation of study drug.
* Clinically significant cardiovascular disease.
* QTcF prolongation \> 480 milliseconds
* HER2+ cohort: left ventricular ejection fraction less than 50%
* Clinically significant pulmonary compromise, including a requirement for supplemental oxygen use to maintain adequate oxygenation.
* Active pneumonitis or history of non-infectious pneumonitis.
* 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 (except in hepatocellular carcinoma) 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
* Confirmed or presumed COVID-19/SARS-CoV-2 infection. While SARS-CoV-2 testing is not mandatory for study entry, testing should follow local clinical practice guidelines/standards. Patients with a positive test result for SARS-CoV-2 infection, known asymptomatic infection, or presumed infection are excluded. Patients may be considered eligible after a resolved SARS-CoV-2 infection once he or she remains afebrile for at least 72 hours and after other SARS-CoV-2-related symptoms have fully recovered to baseline for a minimum of 72 hours.
18 Years
ALL
No
Sponsors
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MacroGenics
INDUSTRY
Responsible Party
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Principal Investigators
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Ashley Ward, MD
Role: STUDY_DIRECTOR
MacroGenics
Locations
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Banner MD Anderson Cancer Center
Gilbert, Arizona, United States
USC/Norris Comprehensive Cancer Center
Los Angeles, California, United States
UCLA Hematology & Oncology Clinic
Los Angeles, California, United States
Hoag Memorial Hospital Presbyterian
Newport Beach, California, United States
Florida Cancer Specialists & Research Institute
Sarasota, Florida, United States
University of Chicago Medicine
Chicago, Illinois, United States
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, United States
Massachusetts General Hospital and Dana-Farber Cancer Institute
Boston, Massachusetts, United States
Duke University Medical Center
Durham, North Carolina, United States
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States
Stephenson Cancer Center, The University of Oklahoma
Oklahoma City, Oklahoma, United States
University of Pennsylvania, Abramson Cancer Center
Philadelphia, Pennsylvania, United States
UPMC Hillman Cancer Center
Pittsburgh, Pennsylvania, United States
Sarah Cannon Research Institute
Nashville, Tennessee, United States
The University of Texas M.D. Anderson Cancer Center
Houston, Texas, United States
St Vincent's Hospital Sydney
Darlinghurst, New South Wales, Australia
Calvary Mater Newcastle
Waratah, New South Wales, Australia
Southern Medical Day Care Centre
Wollongong, New South Wales, Australia
Austin Health Melbourne
Heidelberg, Victoria, Australia
"Complex Oncology Center - Burgas" EOOD
Burgas, , Bulgaria
"Acibadem City Clinic Multiprofile Hospital for Active Treatment Tokuda" EAD, Sofia
Sofia, , Bulgaria
Multiprofile Hospital for Active Treatment "Serdika" EOOD, Sofia
Sofia, , Bulgaria
Prince of Wales Hospital
Shatin, , Hong Kong
Pratia MCM Kraków
Krakow, Lesser Poland Voivodeship, Poland
BioVirtus Research Site Sp. Z o.o. / Biovirtus Centrum Medyczne
Józefów, Masovian Voivodeship, Poland
Narodowy Instytut Onkologii im. Marii Skłodowskiej-Curie Państwowy Instytut Badawczy
Warsaw, Masovian Voivodeship, Poland
Narodowy Instytut Onkologii im. Marii Skłodowskiej-Curie Państwowy Instytut Badawczy
Warsaw, Masovian Voivodeship, Poland
Med-Polonia Sp. z o.o.
Poznan, , Poland
Vall d'Hebron Institute of Oncology
Barcelona, , Spain
Hospital Ruber Internacional
Madrid, , Spain
START Madrid-CIOCC, Hospital HM Sanchinarro
Madrid, , Spain
King Chulalongkorn Memorial Hospital
Bangkok, , Thailand
Maharaj Nakorn Chiang Mai Hospital
Chiang Mai, , Thailand
Songklanagarind Hospital
Songkhla, , Thailand
Communal Nonprofit Enterprise "Cherkassy Regional Oncology Dispensary" of Cherkassy Regional Council
Cherkassy, Cherkasy Oblast, Ukraine
Communal Nonprofit Enterprise Podillia Regional Center of Oncology of Vinnytsia Regional Council
Vinnytsia, Vinnytsa Region, Ukraine
Communal Non-profit Enterprise "City Clinical Hospital #4" of Dnipro City Council
Dnipro, , Ukraine
Communal Nonprofit Enterprise "Prykarpatsky Clinical Oncological Centre of Ivano-Frankivska Regional Council"
Ivano-Frankivsk, , Ukraine
Municipal Non-Profit Enterprise of Sumy Regional Council "Sumy Regional Clinical Oncology Dispensary"
Sumy, , Ukraine
Communal Nonprofit Enterprise "Central City Clinical Hospital of Uzhhorod City Council", City Oncology Center, State Higher Educational Institution <<Uzhhorod National University>>
Uzhhorod, , Ukraine
Countries
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References
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Luke JJ, Patel MR, Blumenschein GR, Hamilton E, Chmielowski B, Ulahannan SV, Connolly RM, Santa-Maria CA, Wang J, Bahadur SW, Weickhardt A, Asch AS, Mallesara G, Clingan P, Dlugosz-Danecka M, Tomaszewska-Kiecana M, Pylypenko H, Hamad N, Kindler HL, Sumrow BJ, Kaminker P, Chen FZ, Zhang X, Shah K, Smith DH, De Costa A, Li J, Li H, Sun J, Moore PA. The PD-1- and LAG-3-targeting bispecific molecule tebotelimab in solid tumors and hematologic cancers: a phase 1 trial. Nat Med. 2023 Nov;29(11):2814-2824. doi: 10.1038/s41591-023-02593-0. Epub 2023 Oct 19.
Other Identifiers
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CP-MGD013-01
Identifier Type: -
Identifier Source: org_study_id