A Study of MGC018 in Combination With MGD019 in Participants With Advanced Solid Tumors
Solid Tumor
Unknown Primary
18 Years and older, Male and Female
CP-MGC018-02 (primary)
NCI-2022-04067
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), immunogenicity, pharmacodynamics, and preliminary antitumor
activity. Participants with relapsed or refractory, unresectable, locally advanced or
metastatic solid tumors including, but not limited to, metastatic castration-resistant
prostate cancer (mCRPC), melanoma, pancreatic cancer, hepatocellular carcinoma (HCC),
ovarian cancer, and renal cell carcinoma (RCC) will be enrolled.
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. .
Eligibility
- 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.
Treatment Sites in Georgia
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