A Study of MGC018 in Combination With MGD019 in Participants With Advanced Solid Tumors
NCT ID: NCT05293496
Last Updated: 2025-10-14
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
31 participants
INTERVENTIONAL
2022-04-19
2025-08-26
Brief Summary
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Vobramitamab duocarmazine and lorigerlimab are administered separately on Day 1 of every 4-week (28-day) cycle at the assigned dose for each cohort. Participants who do not meet criteria for study drug discontinuation may receive study drugs for up to 2 years.
Tumor assessments are performed every 8 weeks (± 7 days) for the initial 6 months on study drugs, then every 12 weeks (± 21 days) until progressive disease (PD).
Participants will be followed for safety throughout the study. .
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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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Cohort -1
vobramitamab duocarmazine at dose level -1 and lorigerlimab intravenously (IV) every 4 weeks
vobramitamab duocarmazine
Vobramitamab duocarmazine is an antibody drug conjugate (ADC) targeted against B7-H3.
lorigerlimab
Lorigerlimab is a bispecific DART® molecule that binds PD-1 and CTLA-4.
Cohort 1
vobramitamab duocarmazine at dose level 1 and lorigerlimab IV every 4 weeks
vobramitamab duocarmazine
Vobramitamab duocarmazine is an antibody drug conjugate (ADC) targeted against B7-H3.
lorigerlimab
Lorigerlimab is a bispecific DART® molecule that binds PD-1 and CTLA-4.
Cohort 2
vobramitamab duocarmazine at dose level 1 and lorigerlimab IV every 4 weeks
vobramitamab duocarmazine
Vobramitamab duocarmazine is an antibody drug conjugate (ADC) targeted against B7-H3.
lorigerlimab
Lorigerlimab is a bispecific DART® molecule that binds PD-1 and CTLA-4.
Cohort 3
vobramitamab duocarmazine at dose level 2 and lorigerlimab IV every 4 weeks
vobramitamab duocarmazine
Vobramitamab duocarmazine is an antibody drug conjugate (ADC) targeted against B7-H3.
lorigerlimab
Lorigerlimab is a bispecific DART® molecule that binds PD-1 and CTLA-4.
Cohort 4
vobramitamab duocarmazine at dose level 3 and lorigerlimab IV every 4 weeks
vobramitamab duocarmazine
Vobramitamab duocarmazine is an antibody drug conjugate (ADC) targeted against B7-H3.
lorigerlimab
Lorigerlimab is a bispecific DART® molecule that binds PD-1 and CTLA-4.
Cohort 5
vobramitamab duocarmazine at dose level 4 and lorigerlimab IV every 4 weeks
vobramitamab duocarmazine
Vobramitamab duocarmazine is an antibody drug conjugate (ADC) targeted against B7-H3.
lorigerlimab
Lorigerlimab is a bispecific DART® molecule that binds PD-1 and CTLA-4.
Cohort Expansion
maximum tolerated dose of vobramitamab duocarmazine and lorigerlimab IV every 4 weeks
vobramitamab duocarmazine
Vobramitamab duocarmazine is an antibody drug conjugate (ADC) targeted against B7-H3.
lorigerlimab
Lorigerlimab is a bispecific DART® molecule that binds PD-1 and CTLA-4.
Interventions
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vobramitamab duocarmazine
Vobramitamab duocarmazine is an antibody drug conjugate (ADC) targeted against B7-H3.
lorigerlimab
Lorigerlimab is a bispecific DART® molecule that binds PD-1 and CTLA-4.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Participants diagnosed with advanced solid tumors including but not limited to metastatic castration-resistant prostate cancer, melanoma, pancreatic cancer, hepatocellular carcinoma, ovarian cancer and renal cell carcinoma.
* Participants have received approved therapies according to their diagnosis.
* Participants must have an available tumor tissue sample. A fresh tumor biopsy may be performed if no archival sample is available.
* Eastern Cooperative Oncology Group performance status of less than or equal to 2.
* Life expectancy of at least 12 weeks.
* Evidence of measurable tumor for evaluation
* Acceptable end organ function according to laboratory results.
* Patients must agree to use highly-effective contraception during the study, and not donate sperm or ova.
Exclusion Criteria
* Another malignancy that required treatment within the past 2 years. Participants who have had curative therapy for non-melanomatous skin cancer, localized prostate cancer (Gleason score \< 6), or carcinoma in situ are eligible for the study.
* Active viral, bacterial, or fungal infection requiring systemic treatment within 1 week of initiation of study drug. Participants are eligible after SARS CoV 2-related symptoms have fully recovered for ≥ 72 hours.
* History of immunodeficiency. Participants with HIV are eligible if they have a CD4+ count ≥ 300/µL, undetectable viral load, and maintained on antiretroviral therapy for a minimum of 4 weeks.
* Prior autologous/allogeneic stem cell or tissue/solid organ transplant
* Prior treatment with MGD009, enoblituzumab, or other B7-H3 targeted agents for cancer.
* Clinically significant cardiovascular disease, lung compromise, venous insufficiency, or gastrointestinal disorders.
* Participants with greater than Grade 1 peripheral neuropathy.
* Participants who have a history of severe adverse events (AEs) from immune checkpoint inhibitors (anti-PD-1, anti-PD-L1, or CTLA-4 inhibitors). All other AEs from prior immune checkpoint inhibitors must be resolved to Grade 1 or less. Participants with any grade neurologic toxicity from prior immune checkpoint inhibitors are excluded.
* Pleural effusion or ascites. Trace pleural or peritoneal fluid is not exclusionary.
* History of Guillain-Barre syndrome, myasthenia gravis, or other autoimmune sensory or motor neuropathies.
18 Years
ALL
No
Sponsors
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MacroGenics
INDUSTRY
Responsible Party
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Principal Investigators
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Denise Casey, M.D.
Role: STUDY_DIRECTOR
MacroGenics
Locations
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University of California, Los Angeles
Los Angeles, California, United States
University of California, San Francisco
San Francisco, California, United States
Florida Cancer Specialists and Research Institute
Sarasota, Florida, United States
Winship Cancer Institute of Emory University
Atlanta, Georgia, United States
Johns Hopkins Sidney Kimmel Comprehensive Cancer Center
Baltimore, Maryland, United States
Weill Cornell Medicine
New York, New York, United States
Carolina BioOncology
Huntersville, North Carolina, United States
Stephenson Cancer Center, The University of Oklahoma
Oklahoma City, Oklahoma, United States
University of Pittsburgh Medical Center, Hillman Cancer Center
Pittsburgh, Pennsylvania, United States
University of Virginia Comprehensive Cancer Center
Charlottesville, Virginia, United States
Countries
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Other Identifiers
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CP-MGC018-02
Identifier Type: -
Identifier Source: org_study_id
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