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A Study of MGD013 in Patients With Unresectable or Metastatic Neoplasms

Primary Purpose

Advanced Solid Tumors, Hematologic Neoplasms, Ovarian Cancer

Status
Completed
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
tebotelimab 1 mg
tebotelimab 3 mg
tebotelimab 10 mg
tebotelimab 30 mg
tebotelimab 120 mg
tebotelimab 300 mg
tebotelimab 400 mg
tebotelimab 600 mg
tebotelimab 800 mg
tebotelimab 1200 mg
margetuximab
Sponsored by
MacroGenics
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Advanced Solid Tumors

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Histologically proven, locally advanced unresectable or metastatic solid tumors (or hematologic malignancies, Cohort Expansion only) 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

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:

  • 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 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.

Sites / Locations

  • Banner MD Anderson Cancer Center
  • USC/Norris Comprehensive Cancer Center
  • UCLA Hematology & Oncology Clinic
  • Hoag Memorial Hospital Presbyterian
  • Florida Cancer Specialists & Research Institute
  • University of Chicago Medicine
  • Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
  • Massachusetts General Hospital and Dana-Farber Cancer Institute
  • Duke University Medical Center
  • Cincinnati Children's Hospital Medical Center
  • Stephenson Cancer Center, The University of Oklahoma
  • University of Pennsylvania, Abramson Cancer Center
  • UPMC Hillman Cancer Center
  • Sarah Cannon Research Institute
  • The University of Texas M.D. Anderson Cancer Center
  • St Vincent's Hospital Sydney
  • Calvary Mater Newcastle
  • Southern Medical Day Care Centre
  • Austin Health Melbourne
  • "Complex Oncology Center - Burgas" EOOD
  • "Acibadem City Clinic Multiprofile Hospital for Active Treatment Tokuda" EAD, Sofia
  • Multiprofile Hospital for Active Treatment "Serdika" EOOD, Sofia
  • Prince of Wales Hospital
  • Pratia MCM Kraków
  • BioVirtus Research Site Sp. Z o.o. / Biovirtus Centrum Medyczne
  • Narodowy Instytut Onkologii im. Marii Skłodowskiej-Curie Państwowy Instytut Badawczy
  • Narodowy Instytut Onkologii im. Marii Skłodowskiej-Curie Państwowy Instytut Badawczy
  • Med-Polonia Sp. z o.o.
  • Vall d'Hebron Institute of Oncology
  • Hospital Ruber Internacional
  • START Madrid-CIOCC, Hospital HM Sanchinarro
  • King Chulalongkorn Memorial Hospital
  • Maharaj Nakorn Chiang Mai Hospital
  • Songklanagarind Hospital
  • Communal Nonprofit Enterprise "Cherkassy Regional Oncology Dispensary" of Cherkassy Regional Council
  • Communal Nonprofit Enterprise Podillia Regional Center of Oncology of Vinnytsia Regional Council
  • Communal Non-profit Enterprise "City Clinical Hospital #4" of Dnipro City Council
  • Communal Nonprofit Enterprise "Prykarpatsky Clinical Oncological Centre of Ivano-Frankivska Regional Council"
  • Municipal Non-Profit Enterprise of Sumy Regional Council "Sumy Regional Clinical Oncology Dispensary"
  • Communal Nonprofit Enterprise "Central City Clinical Hospital of Uzhhorod City Council", City Oncology Center, State Higher Educational Institution <<Uzhhorod National University>>

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm 9

Arm 10

Arm 11

Arm 12

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

Tebotelimab: 1 mg

Tebotelimab 3 mg

Tebotelimab: 10 mg

Tebotelimab: 30 mg

Tebotelimab: 120 mg

Tebotelimab: 400 mg

Tebotelimab: 600 mg

Tebotelimab: 800 mg

Tebotelimab: 1200 mg

Combination cohort 1

Combination Cohort 2

Monotherapy Cohort Expansion

Arm Description

Tebotelimab and margetuximab

Tebotelimab and margetuximab

Monotherapy expansion at 600 mg

Outcomes

Primary Outcome Measures

Number of participants with Treatment-Emergent Adverse Events (TEAE) as assessed by CTCAE v4.03 (tebotelimab monotherapy)
Safety 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.
Number of participants with Treatment-Emergent Adverse Events as assessed by CTCAE v4.03 (tebotelimab plus margetuximab)
Safety

Secondary Outcome Measures

Area Under the Plasma Concentration versus Time Curve (AUC) of tebotelimab
AUC
Maximum Plasma Concentration (Cmax) of tebotelimab and tebotelimab plus margetuximab
Cmax
Time to reach maximum (peak) plasma concentration (Tmax) of tebotelimab and tebotelimab plus margetuximab
Tmax
Trough plasma concentration (Ctrough) of tebotelimab
Ctrough
Total body clearance of the drug from plasma (CL) of tebotelimab
CL
Apparent volume of distribution at steady state (Vss) of tebotelimab
Vss
Terminal half-life (t1/2) of tebotelimab
t1/2
Number of patients with anti-drug antibody
immunogenicity
Objective response rate (ORR)
ORR is the percentage of participants who have a complete response or a partial response to treatment.
Median Duration of response (DoR)
DoR is defined as the time from the date of initial response (CR or PR) to the date of first documented PD or death from any cause, whichever occurs first. Median DoR is the time when 50% of responders are still in response.
Progression-free survival (PFS)
PFS is defined as the time from the first dose date to the date of first documented PD or death from any cause, whichever occurs first. Median PFS is the time when 50% of participants remain free of PD or death.
Median Overall survival (OS)
OS is defined as the time from the first dose date to the date of death from any cause. Median OS is the time when 50% of participants are still alive.

Full Information

First Posted
July 12, 2017
Last Updated
September 14, 2023
Sponsor
MacroGenics
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1. Study Identification

Unique Protocol Identification Number
NCT03219268
Brief Title
A Study of MGD013 in Patients With Unresectable or Metastatic Neoplasms
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
August 18, 2017 (Actual)
Primary Completion Date
February 8, 2023 (Actual)
Study Completion Date
February 8, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
MacroGenics

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The primary goal of this Phase 1 study is to characterize the safety and tolerability of tebotelimab and establish the maximum tolerated dose (MTD) of tebotelimab in advanced solid tumors, and tebotelimab in combination with margetuximab in HER2+ advanced solid tumors. Pharmacokinetics (PK), immunogenicity, pharmacodynamics (PD), and the anti-tumor activity of tebotelimab will also be assessed.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Advanced Solid Tumors, Hematologic Neoplasms, Ovarian Cancer, HER2-positive Advanced Solid Tumors, Non Small Cell Lung Cancer, Small-cell Lung Cancer, Squamous Cell Carcinoma of Head and Neck, Cholangiocarcinoma, Cervical Cancer, TNBC - Triple-Negative Breast Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
353 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Tebotelimab: 1 mg
Arm Type
Experimental
Arm Title
Tebotelimab 3 mg
Arm Type
Experimental
Arm Title
Tebotelimab: 10 mg
Arm Type
Experimental
Arm Title
Tebotelimab: 30 mg
Arm Type
Experimental
Arm Title
Tebotelimab: 120 mg
Arm Type
Experimental
Arm Title
Tebotelimab: 400 mg
Arm Type
Experimental
Arm Title
Tebotelimab: 600 mg
Arm Type
Experimental
Arm Title
Tebotelimab: 800 mg
Arm Type
Experimental
Arm Title
Tebotelimab: 1200 mg
Arm Type
Experimental
Arm Title
Combination cohort 1
Arm Type
Experimental
Arm Description
Tebotelimab and margetuximab
Arm Title
Combination Cohort 2
Arm Type
Experimental
Arm Description
Tebotelimab and margetuximab
Arm Title
Monotherapy Cohort Expansion
Arm Type
Experimental
Arm Description
Monotherapy expansion at 600 mg
Intervention Type
Biological
Intervention Name(s)
tebotelimab 1 mg
Other Intervention Name(s)
MGD013
Intervention Description
1 mg IV every other week
Intervention Type
Biological
Intervention Name(s)
tebotelimab 3 mg
Other Intervention Name(s)
MGD013
Intervention Description
3 mg IV every other week
Intervention Type
Biological
Intervention Name(s)
tebotelimab 10 mg
Other Intervention Name(s)
MGD013
Intervention Description
10 mg IV every other week
Intervention Type
Biological
Intervention Name(s)
tebotelimab 30 mg
Other Intervention Name(s)
MGD013
Intervention Description
30 mg IV every other week
Intervention Type
Biological
Intervention Name(s)
tebotelimab 120 mg
Other Intervention Name(s)
MGD013
Intervention Description
120 mg IV every other week
Intervention Type
Biological
Intervention Name(s)
tebotelimab 300 mg
Other Intervention Name(s)
MGD013
Intervention Description
300 mg IV every other wee
Intervention Type
Biological
Intervention Name(s)
tebotelimab 400 mg
Other Intervention Name(s)
MGD013
Intervention Description
400 mg IV every other wee
Intervention Type
Biological
Intervention Name(s)
tebotelimab 600 mg
Other Intervention Name(s)
MGD013
Intervention Description
600 mg IV every other week
Intervention Type
Biological
Intervention Name(s)
tebotelimab 800 mg
Other Intervention Name(s)
MGD013
Intervention Description
800 mg IV every other week
Intervention Type
Biological
Intervention Name(s)
tebotelimab 1200 mg
Other Intervention Name(s)
MGD013
Intervention Description
1200 mg IV every other week
Intervention Type
Biological
Intervention Name(s)
margetuximab
Other Intervention Name(s)
MGAH22, Margenza
Intervention Description
15 mg/kg IV every 3 weeks
Primary Outcome Measure Information:
Title
Number of participants with Treatment-Emergent Adverse Events (TEAE) as assessed by CTCAE v4.03 (tebotelimab monotherapy)
Description
Safety 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.
Time Frame
up to 24 months
Title
Number of participants with Treatment-Emergent Adverse Events as assessed by CTCAE v4.03 (tebotelimab plus margetuximab)
Description
Safety
Time Frame
up to 24 months
Secondary Outcome Measure Information:
Title
Area Under the Plasma Concentration versus Time Curve (AUC) of tebotelimab
Description
AUC
Time Frame
From Day 1 to Day 15 after the first and second doses
Title
Maximum Plasma Concentration (Cmax) of tebotelimab and tebotelimab plus margetuximab
Description
Cmax
Time Frame
At the end of infusion on Study Days 1, 15, 29 and 43 in Cycles 1 and 2 and on Study Day 1 for all subsequent cycles until treatment discontinuation, up to 2 years
Title
Time to reach maximum (peak) plasma concentration (Tmax) of tebotelimab and tebotelimab plus margetuximab
Description
Tmax
Time Frame
At the end of infusion on Study Days 1, 15, 29 and 43 in Cycles 1 and 2 and on Study Day 1 for all subsequent cycles until treatment discontinuation, up to 2 years
Title
Trough plasma concentration (Ctrough) of tebotelimab
Description
Ctrough
Time Frame
Study Days 1, 15, 29, 43 in Cycles 1 and 2 and Day 1 of each subsequent cycle s until treatment discontinuation, up to 2 years
Title
Total body clearance of the drug from plasma (CL) of tebotelimab
Description
CL
Time Frame
Cycle 1 Day 1 out to Cycle 1 Day 15
Title
Apparent volume of distribution at steady state (Vss) of tebotelimab
Description
Vss
Time Frame
Cycle 1 Day 1 out to Cycle 1 Day 15
Title
Terminal half-life (t1/2) of tebotelimab
Description
t1/2
Time Frame
Cycle 1 Day 1 out to Cycle 1 Day 15
Title
Number of patients with anti-drug antibody
Description
immunogenicity
Time Frame
Study Day 1, 15, 29, 57, 85, 113, then every 56 days up to 2 years Tebotelimab plus margetuximab: Day 1, 22, 43, and then every 6 weeks until treatment discontinuation
Title
Objective response rate (ORR)
Description
ORR is the percentage of participants who have a complete response or a partial response to treatment.
Time Frame
Throughout the study, up to 4 years.
Title
Median Duration of response (DoR)
Description
DoR is defined as the time from the date of initial response (CR or PR) to the date of first documented PD or death from any cause, whichever occurs first. Median DoR is the time when 50% of responders are still in response.
Time Frame
Throughout the study, up to 4 years.
Title
Progression-free survival (PFS)
Description
PFS is defined as the time from the first dose date to the date of first documented PD or death from any cause, whichever occurs first. Median PFS is the time when 50% of participants remain free of PD or death.
Time Frame
Throughout the study, up to 4 years.
Title
Median Overall survival (OS)
Description
OS is defined as the time from the first dose date to the date of death from any cause. Median OS is the time when 50% of participants are still alive.
Time Frame
Throughout the study, up to 4 years.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Histologically proven, locally advanced unresectable or metastatic solid tumors (or hematologic malignancies, Cohort Expansion only) 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 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: 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 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ashley Ward, MD
Organizational Affiliation
MacroGenics
Official's Role
Study Director
Facility Information:
Facility Name
Banner MD Anderson Cancer Center
City
Gilbert
State/Province
Arizona
ZIP/Postal Code
85234
Country
United States
Facility Name
USC/Norris Comprehensive Cancer Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Facility Name
UCLA Hematology & Oncology Clinic
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Facility Name
Hoag Memorial Hospital Presbyterian
City
Newport Beach
State/Province
California
ZIP/Postal Code
92658
Country
United States
Facility Name
Florida Cancer Specialists & Research Institute
City
Sarasota
State/Province
Florida
ZIP/Postal Code
34232
Country
United States
Facility Name
University of Chicago Medicine
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Facility Name
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
Facility Name
Massachusetts General Hospital and Dana-Farber Cancer Institute
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
Cincinnati Children's Hospital Medical Center
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45229
Country
United States
Facility Name
Stephenson Cancer Center, The University of Oklahoma
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104
Country
United States
Facility Name
University of Pennsylvania, Abramson Cancer Center
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
UPMC Hillman Cancer Center
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15232
Country
United States
Facility Name
Sarah Cannon Research Institute
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Facility Name
The University of Texas M.D. Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
St Vincent's Hospital Sydney
City
Darlinghurst
State/Province
New South Wales
ZIP/Postal Code
2010
Country
Australia
Facility Name
Calvary Mater Newcastle
City
Waratah
State/Province
New South Wales
ZIP/Postal Code
2298
Country
Australia
Facility Name
Southern Medical Day Care Centre
City
Wollongong
State/Province
New South Wales
ZIP/Postal Code
2500
Country
Australia
Facility Name
Austin Health Melbourne
City
Heidelberg
State/Province
Victoria
ZIP/Postal Code
3084
Country
Australia
Facility Name
"Complex Oncology Center - Burgas" EOOD
City
Burgas
ZIP/Postal Code
8000
Country
Bulgaria
Facility Name
"Acibadem City Clinic Multiprofile Hospital for Active Treatment Tokuda" EAD, Sofia
City
Sofia
ZIP/Postal Code
1407
Country
Bulgaria
Facility Name
Multiprofile Hospital for Active Treatment "Serdika" EOOD, Sofia
City
Sofia
ZIP/Postal Code
1632
Country
Bulgaria
Facility Name
Prince of Wales Hospital
City
Shatin
Country
Hong Kong
Facility Name
Pratia MCM Kraków
City
Kraków
State/Province
Malopolskie
ZIP/Postal Code
31-510
Country
Poland
Facility Name
BioVirtus Research Site Sp. Z o.o. / Biovirtus Centrum Medyczne
City
Józefów
State/Province
Masovian
ZIP/Postal Code
05-410
Country
Poland
Facility Name
Narodowy Instytut Onkologii im. Marii Skłodowskiej-Curie Państwowy Instytut Badawczy
City
Warszawa
State/Province
Mazowieckie
ZIP/Postal Code
02-034
Country
Poland
Facility Name
Narodowy Instytut Onkologii im. Marii Skłodowskiej-Curie Państwowy Instytut Badawczy
City
Warszawa
State/Province
Mazowieckie
ZIP/Postal Code
02-781
Country
Poland
Facility Name
Med-Polonia Sp. z o.o.
City
Poznań
ZIP/Postal Code
60-693
Country
Poland
Facility Name
Vall d'Hebron Institute of Oncology
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Facility Name
Hospital Ruber Internacional
City
Madrid
ZIP/Postal Code
28034
Country
Spain
Facility Name
START Madrid-CIOCC, Hospital HM Sanchinarro
City
Madrid
ZIP/Postal Code
28050
Country
Spain
Facility Name
King Chulalongkorn Memorial Hospital
City
Bangkok
ZIP/Postal Code
10330
Country
Thailand
Facility Name
Maharaj Nakorn Chiang Mai Hospital
City
Chiang Mai
ZIP/Postal Code
50200
Country
Thailand
Facility Name
Songklanagarind Hospital
City
Songkhla
ZIP/Postal Code
90110
Country
Thailand
Facility Name
Communal Nonprofit Enterprise "Cherkassy Regional Oncology Dispensary" of Cherkassy Regional Council
City
Cherkassy
State/Province
Cherkasy Region
ZIP/Postal Code
18009
Country
Ukraine
Facility Name
Communal Nonprofit Enterprise Podillia Regional Center of Oncology of Vinnytsia Regional Council
City
Vinnytsia
State/Province
Vinnytsa Region
ZIP/Postal Code
21029
Country
Ukraine
Facility Name
Communal Non-profit Enterprise "City Clinical Hospital #4" of Dnipro City Council
City
Dnipro
ZIP/Postal Code
49102
Country
Ukraine
Facility Name
Communal Nonprofit Enterprise "Prykarpatsky Clinical Oncological Centre of Ivano-Frankivska Regional Council"
City
Ivano-Frankivs'k
ZIP/Postal Code
76000
Country
Ukraine
Facility Name
Municipal Non-Profit Enterprise of Sumy Regional Council "Sumy Regional Clinical Oncology Dispensary"
City
Sumy
ZIP/Postal Code
40022
Country
Ukraine
Facility Name
Communal Nonprofit Enterprise "Central City Clinical Hospital of Uzhhorod City Council", City Oncology Center, State Higher Educational Institution <<Uzhhorod National University>>
City
Uzhgorod
ZIP/Postal Code
88000
Country
Ukraine

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

A Study of MGD013 in Patients With Unresectable or Metastatic Neoplasms

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