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| ID | Type | Description | Link |
|---|---|---|---|
| 272201500032C-P00008-9999-1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Allergy and Infectious Diseases (NIAID) | NIH |
| National Institutes of Health (NIH) | NIH |
| Department of Health and Human Services | FED |
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Study CP-MGD020-01 is a phase 1, open-label, dose-escalation, and multi-dose expansion study of MGD020 as a single agent or in combination with MGD014 in persons with HIV-1 (PWH) on antiretroviral therapy (ART). The study is designed to evaluate the safety, tolerability, pharmacokinetics (PK), immunogenicity, and pharmacodynamics (PD) of the study drugs. The study consists of 3 parts (Part 1A, Part 1B, and Part 2). The participant's standard of care ART regimen is continued throughout the study period.
MGD020 is a bispecific DART® molecule that binds CD3 and gp41 subunit of HIV-1 envelope. MGD014 is a bispecific DART® molecule that binds CD3 and gp120 subunit of HIV-1 envelope. These DART molecules redirect CD3+ T lymphocytes to kill HIV-1-infected CD4+ T cells.
Part 1A evaluates groups of participants given a single dose of MGD020. A 2-week safety period is observed prior to escalation to the next dose level. Dose escalation continues until either the maximum tolerated dose (MTD) or maximum administered dose (MAD) is determined.
Part 1B begins after the end of Part 1A. Part 1B evaluates groups of participants given a single dose of the MGD020 MTD or MAD from Part 1A and a fixed dose of of MGD014. The first group will be treated with a single dose of MGD020, at a dose determined to be one dose lower than the single-agent MTD/MAD from Part 1A, and a single 300 mcg/kg dose of MGD014. Dose escalation proceeds until either the MTD or MAD is determined.
Part 2 begins after the end of Part 1B. Part 2 is a multi-dose expansion group. Each participant will receive the MTD or MAD of MGD020 from Part 1B and a fixed dose of MGD014 from Part 1B, administered every 2 weeks (Q2W) for 3 combination doses over 4 weeks. Up to 6 participants may be enrolled in Part 2.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part 1A: Dose level 1 | Experimental | Single dose MGD020 |
|
| Part 1A: Dose level 2 | Experimental | Single dose MGD020 |
|
| Part 1A: Dose level 3 | Experimental | Single dose MGD020 |
|
| Part 1A: Dose level 4 | Experimental | Single dose MGD020 |
|
| Part 1A: Dose level 5 | Experimental | Single dose MGD020 |
|
| Part 1A: Dose level 6 | Experimental | Single dose MGD020 |
|
| Part 1B: MTD/MAD -1 MGD020 and MGD014 |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MGD020 | Biological | MGD020 is a bispecific DART molecule that binds CD3 and gp41 subunit of HIV-1 envelope. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Observation of side effects determines the highest safe dose for further study | Throughout the study, up to 43 days |
| Number and Types of AEs, Including SAEs, and AEs Leading to Treatment Discontinuation in Participants Receiving MGD020 and MGD014 in Part 1B. | Observation of side effects determines the highest safe dose for further study | Throughout the study, up to 43 days |
| Number and Types of AEs, Including SAEs, and AEs Leading to Treatment Discontinuation in Participants Receiving MGD020 and MGD014 in Part 2. | Observation of side effects determines the highest safe dose for further study | Throughout the study, up to 81 days. |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Maximum Concentration of MGD020 | The highest concentration of MGD020 at the end of the infusion | 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 |
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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
On continuous antiretroviral therapy (ART) for at least 24 months prior to screening and must continue ART throughout the study.
CD4 cell count > 350 cells/mm3 at screening
Acceptable laboratory values related to bone marrow, kidney and liver function.
Individuals of childbearing potential must agree to use highly effective forms of contraception throughout the study through 6 months after the last dose of MGD014.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pepi Pencheva, MD | MacroGenics | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Icahn School of Medicine at Mt. Sinai | New York | New York | 10029 | United States | ||
| UNC Hospital - Chapel Hill |
Participants who completed treatment in Part 1A or Part 1B may be considered for treatment in a subsequent cohort in Part B2 or Part 2. Participants must continue to meet all eligibility criteria, not have experienced severe adverse events in Part 1, and do not have detectable antidrug antibodies against prior study treatment.
Subsequent treatments assignments are not defined in advance when entering the study.
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| ID | Title | Description |
|---|---|---|
| FG000 | Part 1A: Cohort 1 | Single dose: 1 mcg/kg MGD020 administered IV |
| FG001 | Part 1A: Cohort 2 | Single dose: 3 mcg/kg MGD020 administered IV |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Part 1A |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jan 12, 2023 | Oct 30, 2024 |
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| Experimental |
Single dose MGD020 and MGD014 |
|
| Part 1B: MTD/MAD MGD020 and MGD014 | Experimental | Single dose MGD020 and MGD014 |
|
| Part 2: MGD020 and MGD014 | Experimental | Multiple doses of MGD020 and MGD014 |
|
| MGD014 | Biological | MGD014 is a bispecific DART molecule that binds CD3 and gp120 subunit of HIV-1 envelope. |
|
The highest concentration of MGD014 at the end of the infusion (Cmax).
| 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 | The amount of time required to get 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 Time to Maximal Concentration of MGD014 | The amount of time required to get maximum concentration of MGD014 | Throughout the study, up to 43 days for Part 1B, and up to 78 days for Part 2 |
| Mean Area Under the Concentration-time Curve (AUC) of MGD020 | Total body exposure to MGD020 | Throughout the study, up to 43 days for Parts 1A and 1B, and up to 78 days for Part 2 |
| Mean AUC of MGD014 | Total body exposure to MGD014 | Throughout the study, up to 43 days for Parts 1B, and up to 78 days for Part 2 |
| Mean Half-life of MGD020 | The amount of time needed for the body to clear half of the dose of MGD020 | Throughout the study, up to 43 days for Parts 1A and 1B, and up to 78 days for Part 2 |
| Mean Half-life of MGD014 | The amount of time needed for the body to clear half of the dose of MGD014 | Throughout the study, up to 43 days for Parts 1B, and up to 78 days for Part 2 |
| Mean Volume of Distribution at Steady State (Vss) of MGD020 | This parameter measures how much of the drug remains in the bloodstream or is distributed to body tissues. | Throughout the study, up to 78 days for Part 2 |
| Mean Volume of Distribution at Steady State of MGD014 | This parameter measures how much of the drug remains in the bloodstream or is distributed to body tissues. | Throughout the study, up to 78 days for Part 2 |
| Mean Clearance of MGD020 | Total body clearance of the drug from plasma of MGD020 | Throughout the study, up to 43 days for Parts 1A and 1B, and up to 78 days for Part 2 |
| Mean Clearance of MGD014 | Total body clearance of the drug from plasma of MGD014 | Throughout the study, up to 43 days for Parts 1B, and up to 78 days for Part 2 |
| Number of Participants With Elevations in Serum Cytokine Levels of IFN-γ, IL-2, IL-5, IL-6, IL-10, or TNF-α | Throughout the study, up to 43 days for Parts 1A and 1B, and up to 78 days for Part 2. |
| Anti-drug Antibody Formation to MGD020 | Number of patients who develop antibodies against MDG020 | Throughout the study, up to 43 days for Parts 1A and 1B, and up to 78 days for Part 2 |
| Anti-drug Antibody Formation to MGD014 | Number of patients who develop antibodies against MDG014 | Throughout the study, up to 43 days for Parts 1B, and up to 78 days for Part 2 |
| Chapel Hill |
| North Carolina |
| 27599 |
| United States |
| Case Western Reserve University Hospital | Cleveland | Ohio | 44106 | United States |
| FG002 | Part 1A: Cohort 3 | Single dose: 10 mcg/kg MGD020 administered IV |
| FG003 | Part 1A: Cohort 4 | Single dose: 30 mcg/kg MGD020 administered IV |
| FG004 | Part 1A: Cohort 5 | Single dose: 100 mcg/kg MGD020 administered IV |
| FG005 | Part 1A: Cohort 6 | Single dose: 300 mcg/kg MGD020 administered IV |
| FG006 | Part 1B: Cohort 1 | Single dose: 100 mcg/kg MGD020 + 300 mcg/kg MGD014 administered IV. |
| FG007 | Part 1B: Cohort 2 | Single dose: 300 mcg/kg MGD020 + 300 mcg/kg MGD014 administered IV. |
| FG008 | Part 2 | Three doses: 300 mcg/kg MGD020 + 300 mcg/kg MGD014 administered IV once every 2 weeks for 4 weeks. |
| Participant Treated in 1A Cohort 2 and Part IB Cohort 1 |
|
| Participant Treated in 1A Cohort 4, 1B Cohort 2 and Part 2 |
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| Participant Treated in 1A Cohort 4 and Part 2 |
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| Participant Treated in 1A Cohort 5 and 1B Cohort 1 |
|
| Participant Treated in 1A Cohort 5 and 1B Cohort 2 |
|
| COMPLETED |
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| NOT COMPLETED |
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| Part 1B |
|
| Part 2 |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Part 1A: Cohort 1 | Single dose: 1 mcg/kg MGD020 administered IV |
| BG001 | Part 1A: Cohort 2 | Single dose: 3 mcg/kg MGD020 administered IV |
| BG002 | Part 1A: Cohort 3 | Single dose: 10 mcg/kg MGD020 administered IV |
| BG003 | Part 1A: Cohort 4 | Single dose: 30 mcg/kg MGD020 administered IV |
| BG004 | Part 1A: Cohort 5 | Single dose: 100 mcg/kg MGD020 administered IV |
| BG005 | Part 1A: Cohort 6 | Single dose: 300 mcg/kg MGD020 administered IV |
| BG006 | Part 1B: Cohort 1 | Single dose: 100 mcg/kg MGD020 + 300 mcg/kg MGD014 administered IV. |
| BG007 | Part 1B: Cohort 2 | Single dose: 300 mcg/kg MGD020 + 300 mcg/kg MGD014 administered IV. |
| BG008 | Part 2 | Three doses: 300 mcg/kg MGD020 + 300 mcg/kg MGD014 administered IV once every 2 weeks for 4 weeks. |
| BG009 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Baseline characteristics are reported separately for each cohort. | Mean | Standard Deviation | years |
| |||||||||
| Sex: Female, Male | Baseline demographics are presented for each cohort in different rows. | Count of Participants | Participants |
| ||||||||||
| Race/Ethnicity, Customized | Baseline demographics are reported separately for each cohort. | Count of Participants | Participants |
| ||||||||||
| Region of Enrollment | All participants in Part 1A were enrolled in the United States. | Number | participants |
| ||||||||||
| Region of Enrollment | All participants in Part 1B were enrolled in the United States. | Number | participants |
| ||||||||||
| Region of Enrollment | All participants in Part 2 were enrolled in the United States. | Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 | Observation of side effects determines the highest safe dose for further study | Posted | Number | participants with adverse events by type | Throughout the study, up to 43 days |
|
|
| ||||||||||||||||||||||||||||||||||||||||||
| Primary | Number and Types of AEs, Including SAEs, and AEs Leading to Treatment Discontinuation in Participants Receiving MGD020 and MGD014 in Part 1B. | Observation of side effects determines the highest safe dose for further study | Posted | Number | participants with AE by type | Throughout the study, up to 43 days |
|
| |||||||||||||||||||||||||||||||||||||||||||
| Primary | Number and Types of AEs, Including SAEs, and AEs Leading to Treatment Discontinuation in Participants Receiving MGD020 and MGD014 in Part 2. | Observation of side effects determines the highest safe dose for further study | Posted | Number | participants with AE by type | Throughout the study, up to 81 days. |
|
| |||||||||||||||||||||||||||||||||||||||||||
| Secondary | Mean Maximum Concentration of MGD020 | The highest concentration of MGD020 at the end of the infusion | All participants who received ay least a single-dose of MGD020, and had at least 1 measurable concentration above the lower limit of quantification (LLOQ). One participant in Part A, cohort 4 was excluded from the analysis due to no measurable concentration above the LLOQ. Mean Cmax for Part 2 is after the third infusion. | Posted | Mean | 95% Confidence Interval | mcg/liter | Throughout the study, up to 43 days for Parts 1A and 1B, and up to 78 days for Part 2 |
| ||||||||||||||||||||||||||||||||||||||||||
| Secondary | Mean Maximum Concentration of MGD014 | The highest concentration of MGD014 at the end of the infusion (Cmax). | All participants who received at least a single-dose of MGD014, and had at least 1 measurable concentration above the LLOQ. Mean Cmax for Part 2 is after the third infusion. | Posted | Mean | 95% Confidence Interval | mcg/liter | Throughout the study, up to 43 days for Part 1B, and up to 78 days for Part 2 |
|
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| Secondary | Mean Time to Maximal Concentration of MGD020 | The amount of time required to get maximum concentration of MGD020 | All participants who received at least a single-dose of MGD020, and had at least 1 measurable concentration above the LLOQ. One participant in Part A, cohort 4 was excluded from the analysis due to no measurable concentration above the LLOQ.. Mean Tmax for Part 2 is after the first infusion. | Posted | Mean | Full Range | hours | Throughout the study, up to 43 days for Parts 1A and 1B, and up to 78 days for Part 2 |
| ||||||||||||||||||||||||||||||||||||||||||
| Secondary | Mean Time to Maximal Concentration of MGD014 | The amount of time required to get maximum concentration of MGD014 | All participants who received at least a single-dose of MGD014, and had at least 1 measurable concentration above the LLOQ. Mean Tmax for Part 2 is after the first infusion. | Posted | Mean | Full Range | hours | Throughout the study, up to 43 days for Part 1B, and up to 78 days for Part 2 |
|
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| Secondary | Mean Area Under the Concentration-time Curve (AUC) of MGD020 | Total body exposure to MGD020 | All participants who received at least a single-dose of MGD020, and had at least 1 measurable concentration above the LLOQ. One participant in Part A, cohort 4 was excluded from the analysis due to no measurable concentration above the LLOQ. Mean AUC for Part 2 is after the first infusion. | Posted | Mean | 95% Confidence Interval | mcg*hour/liter | Throughout the study, up to 43 days for Parts 1A and 1B, and up to 78 days for Part 2 |
| ||||||||||||||||||||||||||||||||||||||||||
| Secondary | Mean AUC of MGD014 | Total body exposure to MGD014 | All participants who received at least a single-dose of MGD014, and had at least 1 measurable concentration above the LLOQ. Mean AUC for Part 2 is after the first infusion. | Posted | Mean | 95% Confidence Interval | mcg*hour/liter | Throughout the study, up to 43 days for Parts 1B, and up to 78 days for Part 2 |
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| Secondary | Mean Half-life of MGD020 | The amount of time needed for the body to clear half of the dose of MGD020 | All participants who received at least a single-dose of MGD020, and had at least 1 measurable concentration above the LLOQ. One participant in Part A, cohort 4 was excluded from the analysis due to no measurable concentration above the LLOQ.. Mean half-life for Part 2 is after the third infusion. | Posted | Mean | 95% Confidence Interval | hours | Throughout the study, up to 43 days for Parts 1A and 1B, and up to 78 days for Part 2 |
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| Secondary | Mean Half-life of MGD014 | The amount of time needed for the body to clear half of the dose of MGD014 | All participants who received at least a single-dose of MGD014, and had at least 1 measurable concentration above the LLOQ. Mean AUC for Part 2 is after the third infusion. | Posted | Mean | 95% Confidence Interval | hours | Throughout the study, up to 43 days for Parts 1B, and up to 78 days for Part 2 |
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| Secondary | Mean Volume of Distribution at Steady State (Vss) of MGD020 | This parameter measures how much of the drug remains in the bloodstream or is distributed to body tissues. | Only participants who received at least 3 doses of MGD020 can be evaluated for Vss. All other cohorts receive only 1 dose, so Vss cannot be calculated in Parts 1A and 1B. Vss is reported only for Part 2 after the third dose of MGD020. | Posted | Mean | 95% Confidence Interval | liters | Throughout the study, up to 78 days for Part 2 |
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| Secondary | Mean Volume of Distribution at Steady State of MGD014 | This parameter measures how much of the drug remains in the bloodstream or is distributed to body tissues. | Only participants who received at least 3 doses of MGD014 can be evaluated for Vss. All other cohorts receive only 1 dose, so Vss cannot be calculated in Parts 1A and 1B. Vss is reported only in Part 2 after the third dose of MGD014. | Posted | Mean | 95% Confidence Interval | liters | Throughout the study, up to 78 days for Part 2 |
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| Secondary | Mean Clearance of MGD020 | Total body clearance of the drug from plasma of MGD020 | All participants who received at least a single-dose of MGD020, and had at least 1 measurable concentration above the LLOQ. One participant in Part A, cohort 4 was excluded from analysis due to no measurable concentration above the LLOQ. | Posted | Mean | 95% Confidence Interval | liters | Throughout the study, up to 43 days for Parts 1A and 1B, and up to 78 days for Part 2 |
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| Secondary | Mean Clearance of MGD014 | Total body clearance of the drug from plasma of MGD014 | All participants who received at least one dose of MGD014. Clearance for Part 2 is reported after the third dose of MGD014. | Posted | Mean | 95% Confidence Interval | liters | Throughout the study, up to 43 days for Parts 1B, and up to 78 days for Part 2 |
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| Secondary | Number of Participants With Elevations in Serum Cytokine Levels of IFN-γ, IL-2, IL-5, IL-6, IL-10, or TNF-α | All participants who received at least one dose of assigned study treatment. | Posted | Count of Participants | Participants | Throughout the study, up to 43 days for Parts 1A and 1B, and up to 78 days for Part 2. |
| ||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Anti-drug Antibody Formation to MGD020 | Number of patients who develop antibodies against MDG020 | All participants who received at least one dose of assigned study treatment. | Posted | Count of Participants | Participants | Throughout the study, up to 43 days for Parts 1A and 1B, and up to 78 days for Part 2 |
| |||||||||||||||||||||||||||||||||||||||||||
| Secondary | Anti-drug Antibody Formation to MGD014 | Number of patients who develop antibodies against MDG014 | All participants who received at least 1 dose of MGD014. Participants in Part 1A did not receive MGD014. | Posted | Count of Participants | Participants | Throughout the study, up to 43 days for Parts 1B, and up to 78 days for Part 2 |
|
|
The safety assessment is based on evaluation of AEs occurring from the first administration of study drug(s) through the End of Study Visit or 30 days after the last dose of study drug(s) [up to approximately Day 43 in Part 1A and 1B, and up to approximately 81 days in Part 2] , whichever is later. The safety assessment is based on signs, symptoms, physical examination findings, and laboratory test results.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Part 1A: Cohort 1 | Single dose: 1 mcg/kg MGD-020 administered IV | 0 | 1 | 0 | 1 | 1 | 1 |
| EG001 | Part 1A: Cohort 2 | Single dose: 3 mcg/kg MGD-020 administered IV | 0 | 1 | 0 | 1 | 1 | 1 |
| EG002 | Part 1A: Cohort 3 | Single dose: 10 mcg/kg MGD-020 administered IV | 0 | 1 | 0 | 1 | 1 | 1 |
| EG003 | Part 1A: Cohort 4 | Single dose: 30 mcg/kg MGD-020 administered IV | 0 | 3 | 0 | 3 | 3 | 3 |
| EG004 | Part 1A: Cohort 5 | Single dose: 100 mcg/kg MGD020 administered IV | 0 | 3 | 0 | 3 | 1 | 3 |
| EG005 | Part 1A: Cohort 6 | Single dose: 300 mcg/kg MGD-020 administered IV | 0 | 6 | 0 | 6 | 5 | 6 |
| EG006 | Part 1B: Cohort 1 | Single dose: 100 mcg/kg MGD-020 + 300 mcg/kg MGD014 administered IV. | 0 | 3 | 0 | 3 | 2 | 3 |
| EG007 | Part 1B: Cohort 2 | Single dose: 300 mcg/kg MGD-020 + 300 mcg/kg MGD014 administered IV. | 0 | 3 | 0 | 3 | 1 | 3 |
| EG008 | Part 2 | Three doses: 300 mcg/kg MGD-020 + 300 mcg/kg MGD014 administered IV once every 2 weeks for 4 weeks. | 0 | 3 | 0 | 3 | 2 | 3 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Tachycardia | Cardiac disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Vision blurred | Eye disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Visual field defect | Eye disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Dry mouth | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Gingival pain | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Lip dry | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Tongue coated | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Chills | General disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Feeling abnormal | General disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Injection site pain | General disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Swelling face | General disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Vessel puncture site bruise | General disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Seasonal allergy | Immune system disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Pustule | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Burns second degree | Injury, poisoning and procedural complications | MedDRA 27.0 | Systematic Assessment |
| |
| Skin laceration | Injury, poisoning and procedural complications | MedDRA 27.0 | Systematic Assessment |
| |
| Vascular access site vesicles | Injury, poisoning and procedural complications | MedDRA 27.0 | Systematic Assessment |
| |
| Blood pressure increased | Investigations | MedDRA 27.0 | Systematic Assessment |
| |
| Glomerular filtration rate decreased | Investigations | MedDRA 27.0 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA 27.0 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA 27.0 | Systematic Assessment |
| |
| Bilirubin conjugated increased | Investigations | MedDRA 27.0 | Systematic Assessment |
| |
| Blood bilirubin increased | Investigations | MedDRA 27.0 | Systematic Assessment |
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| Blood phosphorus decreased | Investigations | MedDRA 27.0 | Systematic Assessment |
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| Carbon dioxide decreased | Investigations | MedDRA 27.0 | Systematic Assessment |
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| Urine output decreased | Investigations | MedDRA 27.0 | Systematic Assessment |
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| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 27.0 | Systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 27.0 | Systematic Assessment |
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| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 27.0 | Systematic Assessment |
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| Joint swelling | Musculoskeletal and connective tissue disorders | MedDRA 27.0 | Systematic Assessment |
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| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Plantar fasciitis | Musculoskeletal and connective tissue disorders | MedDRA 27.0 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 27.0 | Systematic Assessment |
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| Brain fog | Nervous system disorders | MedDRA 27.0 | Systematic Assessment |
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| Head discomfort | Nervous system disorders | MedDRA 27.0 | Systematic Assessment |
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| Panic attack | Psychiatric disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Night sweats | Skin and subcutaneous tissue disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Skin burning sensation | Skin and subcutaneous tissue disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA 27.0 | Systematic Assessment |
|
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chief Medical Officer | MacroGenics, Inc. | 301-251-5172 | info@macrogenics.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | May 7, 2024 | Oct 30, 2024 | SAP_001.pdf |
| ID | Term |
|---|---|
| D000163 | Acquired Immunodeficiency Syndrome |
| ID | Term |
|---|---|
| D015658 | HIV Infections |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D012897 | Slow Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
Not provided
Not provided
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| Part 1B |
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| Part 2 |
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| Part 1B |
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| Part 2 |
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| Part 1B: Asian |
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| Part 2: Asian |
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| Part 1A Black or African American |
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| Part 1B Black or African American |
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| Part 2: Black or African American |
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| Part 1A: White |
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| Part 1B: White |
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| Part 2: White |
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| Part 1A: American Indian or Alaska Native |
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| Part 1B: American Indian or Alaska Native |
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| Part 2: American Indian or Alaska Native |
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| Part 1A: Not Reported |
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| Part 1B: Not Reported |
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| Part 2: Not Reported |
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| Part 1A: Other |
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| Part 1B: Other |
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| Part 2: Other |
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| Part 1A: Hispanic |
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| Part 1B: Hispanic |
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| Part 2: Hispanic |
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| Part 1A: Not Hispanic |
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| Part 1B: Not Hispanic |
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| Part 2: Not Hispanic |
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| Treatment-related Adverse Event |
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| Severe adverse event |
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| Treatment-related severe adverse event |
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| Event leading to MGD020 withdrawal |
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| Title | Denominators | Categories |
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| Any AE |
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| Treatment-related AE |
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| Severe AE |
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| Severe treatment-related AE |
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| Event leading to MGD020 withdrawal |
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| Event leading to MGD014 withdrawal |
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| OG004 |
| Part 1A: Cohort 5 |
Single dose: 100 mcg/kg MGD020 administered IV |
| OG005 | Part 1A: Cohort 6 | Single dose: 300 mcg/kg MGD020 administered IV |
| OG006 | Part 1B: Cohort 1 | Single dose: 100 mcg/kg MGD020 + 300 mcg/kg MGD014 administered IV. |
| OG007 | Part 1B: Cohort 2 | Single dose: 300 mcg/kg MGD020 + 300 mcg/kg MGD014 administered IV. |
| OG008 | Part 2 | Three doses: 300 mcg/kg MGD020 + 300 mcg/kg MGD014 administered IV once every 2 weeks for 4 weeks. |
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| Part 1A: Cohort 5 |
Single dose: 100 mcg/kg MGD020 administered IV |
| OG005 | Part 1A: Cohort 6 | Single dose: 300 mcg/kg MGD020 administered IV |
| OG006 | Part 1B: Cohort 1 | Single dose: 100 mcg/kg MGD020 + 300 mcg/kg MGD014 administered IV. |
| OG007 | Part 1B: Cohort 2 | Single dose: 300 mcg/kg MGD020 + 300 mcg/kg MGD014 administered IV. |
| OG008 | Part 2 | Three doses: 300 mcg/kg MGD020 + 300 mcg/kg MGD014 administered IV once every 2 weeks for 4 weeks. |
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| Part 1A: Cohort 5 |
Single dose: 100 mcg/kg MGD020 administered IV |
| OG005 | Part 1A: Cohort 6 | Single dose: 300 mcg/kg MGD020 administered IV |
| OG006 | Part 1B: Cohort 1 | Single dose: 100 mcg/kg MGD020 + 300 mcg/kg MGD014 administered IV. |
| OG007 | Part 1B: Cohort 2 | Single dose: 300 mcg/kg MGD020 + 300 mcg/kg MGD014 administered IV. |
| OG008 | Part 2 | Three doses: 300 mcg/kg MGD020 + 300 mcg/kg MGD014 administered IV once every 2 weeks for 4 weeks. |
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| OG004 |
| Part 1A: Cohort 5 |
Single dose: 100 mcg/kg MGD020 administered IV |
| OG005 | Part 1A: Cohort 6 | Single dose: 300 mcg/kg MGD020 administered IV |
| OG006 | Part 1B: Cohort 1 | Single dose: 100 mcg/kg MGD020 + 300 mcg/kg MGD014 administered IV. |
| OG007 | Part 1B: Cohort 2 | Single dose: 300 mcg/kg MGD020 + 300 mcg/kg MGD014 administered IV. |
| OG008 | Part 2 | Three doses: 300 mcg/kg MGD020 + 300 mcg/kg MGD014 administered IV once every 2 weeks for 4 weeks. |
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| Part 1A: Cohort 5 |
Single dose: 100 mcg/kg MGD020 administered IV |
| OG005 | Part 1A: Cohort 6 | Single dose: 300 mcg/kg MGD020 administered IV |
| OG006 | Part 1B: Cohort 1 | Single dose: 100 mcg/kg MGD020 + 300 mcg/kg MGD014 administered IV. |
| OG007 | Part 1B: Cohort 2 | Single dose: 300 mcg/kg MGD020 + 300 mcg/kg MGD014 administered IV. |
| OG008 | Part 2 | Three doses: 300 mcg/kg MGD020 + 300 mcg/kg MGD014 administered IV once every 2 weeks for 4 weeks. |
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| Part 1A: Cohort 5 |
Single dose: 100 mcg/kg MGD020 administered IV |
| OG005 | Part 1A: Cohort 6 | Single dose: 300 mcg/kg MGD020 administered IV |
| OG006 | Part 1B: Cohort 1 | Single dose: 100 mcg/kg MGD020 + 300 mcg/kg MGD014 administered IV. |
| OG007 | Part 1B: Cohort 2 | Single dose: 300 mcg/kg MGD020 + 300 mcg/kg MGD014 administered IV. |
| OG008 | Part 2 | Three doses: 300 mcg/kg MGD020 + 300 mcg/kg MGD014 administered IV once every 2 weeks for 4 weeks. |
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Single dose: 100 mcg/kg MGD020 administered IV |
| OG005 | Part 1A: Cohort 6 | Single dose: 300 mcg/kg MGD020 administered IV |
| OG006 | Part 1B: Cohort 1 | Single dose: 100 mcg/kg MGD020 + 300 mcg/kg MGD014 administered IV. |
| OG007 | Part 1B: Cohort 2 | Single dose: 300 mcg/kg MGD020 + 300 mcg/kg MGD014 administered IV. |
| OG008 | Part 2 | Three doses: 300 mcg/kg MGD020 + 300 mcg/kg MGD014 administered IV once every 2 weeks for 4 weeks. |
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| OG005 | Part 1A: Cohort 6 | Single dose: 300 mcg/kg MGD020 administered IV |
| OG006 | Part 1B: Cohort 1 | Single dose: 100 mcg/kg MGD020 + 300 mcg/kg MGD014 administered IV. |
| OG007 | Part 1B: Cohort 2 | Single dose: 300 mcg/kg MGD020 + 300 mcg/kg MGD014 administered IV. |
| OG008 | Part 2 | Three doses: 300 mcg/kg MGD020 + 300 mcg/kg MGD014 administered IV once every 2 weeks for 4 weeks. |
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| OG005 | Part 1A: Cohort 6 | Single dose: 300 mcg/kg MGD020 administered IV |
| OG006 | Part 1B: Cohort 1 | Single dose: 100 mcg/kg MGD020 + 300 mcg/kg MGD014 administered IV. |
| OG007 | Part 1B: Cohort 2 | Single dose: 300 mcg/kg MGD020 + 300 mcg/kg MGD014 administered IV. |
| OG008 | Part 2 | Three doses: 300 mcg/kg MGD020 + 300 mcg/kg MGD014 administered IV once every 2 weeks for 4 weeks. |
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