Status:
COMPLETED
A Study of MGC018 in Combination With MGD019 in Participants With Advanced Solid Tumors
Lead Sponsor:
MacroGenics
Conditions:
Advanced Solid Tumor
Castration-Resistant Prostatic Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
Study CP-MGC018-02 is a study of vobramitamab duocarmazine (MGC018) in combination with lorigerlimab (MGD019). The study is designed to characterize safety, tolerability, pharmacokinetics (PK), immuno...
Eligibility Criteria
Inclusion
- 1\. Ability to provide and document informed consent and willing and able to comply with all study procedures.
- 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
- Any underlying medical or psychiatric condition impairing participant's ability to receive, tolerate, or comply with the planned treatment or study procedures.
- 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.
Key Trial Info
Start Date :
April 19 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 26 2025
Estimated Enrollment :
31 Patients enrolled
Trial Details
Trial ID
NCT05293496
Start Date
April 19 2022
End Date
August 26 2025
Last Update
October 14 2025
Active Locations (10)
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1
University of California, Los Angeles
Los Angeles, California, United States, 90095
2
University of California, San Francisco
San Francisco, California, United States, 94115
3
Florida Cancer Specialists and Research Institute
Sarasota, Florida, United States, 34232
4
Winship Cancer Institute of Emory University
Atlanta, Georgia, United States, 30322