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MGD020

Phase 1

Human Immunodeficiency Virus I Infection | Monoclonal antibody | Infectious Disease |MacroGenics, Inc.|Last Updated: Mar 28, 2025

Success Probability

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Trial Design

CONTROLLED
Total Trials1
Total Enrollment17

FDA Designations

No designations recorded

Clinical trial landscape

MGD020 · 1 trial · 3 indications

Phase 1 1
NCT05261191A Study of MGD020 Alone or Combined With MGD014 in Persons With HIV-1 on Antiretroviral TherapyHuman Immunodeficiency Virus I Infection
COMPLETED17 Analytics
PHASE1COMPLETED
A Study of MGD020 Alone or Combined With MGD014 in Persons With HIV-1 on Antiretroviral Therapy
Human Immunodeficiency Virus I InfectionUnlock trial analytics

Study Endpoints

Primary Endpoints

Number and Types of Adverse Events (AEs), Including Serious Adverse Events (SAEs), and AEs Leading to Treatment Discontinuation in Participants Receiving MGD020 Alone in Part 1A
Throughout the study, up to 43 days

Observation of side effects determines the highest safe dose for further study

Number and Types of AEs, Including SAEs, and AEs Leading to Treatment Discontinuation in Participants Receiving MGD020 and MGD014 in Part 1B.
Throughout the study, up to 43 days

Observation of side effects determines the highest safe dose for further study

Number and Types of AEs, Including SAEs, and AEs Leading to Treatment Discontinuation in Participants Receiving MGD020 and MGD014 in Part 2.
Throughout the study, up to 81 days.

Observation of side effects determines the highest safe dose for further study

Secondary Endpoints

Mean Maximum Concentration of MGD020
Throughout the study, up to 43 days for Parts 1A and 1B, and up to 78 days for Part 2
Mean Maximum Concentration of MGD014
Throughout the study, up to 43 days for Part 1B, and up to 78 days for Part 2
Mean Time to Maximal Concentration of MGD020
Throughout the study, up to 43 days for Parts 1A and 1B, and up to 78 days for Part 2
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelSEQUENTIAL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Part 1A: Dose level 1EXPERIMENTALSingle dose MGD020
Part 1A: Dose level 2EXPERIMENTALSingle dose MGD020
Part 1A: Dose level 3EXPERIMENTALSingle dose MGD020
Part 1A: Dose level 4EXPERIMENTALSingle dose MGD020
Part 1A: Dose level 5EXPERIMENTALSingle dose MGD020
Part 1A: Dose level 6EXPERIMENTALSingle dose MGD020
Part 1B: MTD/MAD -1 MGD020 and MGD014EXPERIMENTALSingle dose MGD020 and MGD014
Part 1B: MTD/MAD MGD020 and MGD014EXPERIMENTALSingle dose MGD020 and MGD014
Part 2: MGD020 and MGD014EXPERIMENTALMultiple doses of MGD020 and MGD014

Interventions

NameTypeDescription
MGD020BIOLOGICALMGD020 is a bispecific DART molecule that binds CD3 and gp41 subunit of HIV-1 envelope.
MGD014BIOLOGICALMGD014 is a bispecific DART molecule that binds CD3 and gp120 subunit of HIV-1 envelope.
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Eligibility Criteria

Age Range18 Years to 70 Years
SexALL
Healthy VolunteersNo
Study Sites3

Inclusion Criteria: * Aged ≥ 18 years and ≤ 70 years of age and able to provide informed consent * HIV-1 infection documented by rapid HIV test or HIV enzyme or chemiluminescence immunoassay and confirmed by a different second test. * Plasma HIV-1 RNA viral load * \< 50 copies/mL at 2 time point...

Countries:United States
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Frequently asked questions about MGD020

What is MGD020 used for?

MGD020 is an investigational monoclonal antibody being developed for the treatment of Human Immunodeficiency Virus I Infection (HIV-1). It is currently in Phase 1 clinical development and has been studied in patients with HIV-1 who are on antiretroviral therapy.

What does MGD020 target?

MGD020 is a monoclonal antibody designed to target HIV-1. It is being studied for its potential to treat Human Immunodeficiency Virus I Infection, and it is being evaluated alone or in combination with another investigational antibody, MGD014, in clinical trials.

Who makes MGD020?

MGD020 is being developed by MacroGenics, Inc., a biopharmaceutical company traded on the Nasdaq under the ticker symbol MGNX. The company is conducting clinical research on this investigational monoclonal antibody for the treatment of HIV-1 infection.

What phase is MGD020 in?

MGD020 is in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities. A Phase 1 study of MGD020 has been completed, and the drug remains in early-stage clinical evaluation for HIV-1 infection.

What clinical trials is MGD020 in?

MGD020 has been studied in one clinical trial, identified as NCT05261191, titled 'A Study of MGD020 Alone or Combined With MGD014 in Persons With HIV-1 on Antiretroviral Therapy.' This Phase 1 trial enrolled 17 participants in the United States and has been completed.

Is MGD020 the same as MGD014?

No, MGD020 and MGD014 are different investigational monoclonal antibodies. They are being studied together in a clinical trial for HIV-1 infection, where MGD020 is evaluated alone or in combination with MGD014. Both are being developed by MacroGenics, Inc.