This is a multicenter, open-label FIH, Phase 1a (dose escalation), Phase 1b (dose expansion) and Phase 2 study in patients with advanced metastatic solid tumors refractory to standard treatment.
Provide written consent on an informed consent form (ICF), approved by an Institutional Review Board (IRB)/Independent Ethics Committee (IEC), prior to any study-specific evaluation. Patients should have the ability to read and understand the ICF, ask for any clarifications from the study staff, and be able to comply with all planned study procedures.
18 years of age or older at the time of informed consent.
Must be nonlactating and have a negative serum (preferred) or urine pregnancy test results within 72 hours prior to the first dose of MBRC-201.
Must agree not to try to become pregnant during the study and for at least 6 months after the final dose of MBRC-201
Non-melanoma skin cancer considered completely cured;
Localized prostate cancer treated with curative intent with no evidence of progression;
Low-risk or very low-risk (per standard clinical guidelines) localized prostate cancer under active surveillance without immediate intent to treat;
Malignancy that is otherwise considered cured with minimal risk of recurrence.