Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
MacroGenics
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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.
Prior autologous/allogeneic stem cell or tissue/solid organ transplant
Prior treatment with MGD009, enoblituzumab, or other B7-H3 targeted agents for cancer.
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.
You may not be if
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.
Clareo Health | A Study of MGC018 in Combination With MGD019 in Participants With Advanced Solid Tumors
