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.
Single group
ADC
DrugMBRC-201 ADC
Type, incidence, severity, seriousness, and relatedness of adverse events (AEs)
• TEAEs will be graded according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v.5.0.
• Incidence and prevalence of Dose-limiting Toxicities (DLTs) and cumulative safety by dose level
The DLTs are specific adverse events and are defined as any of the following: high grade non-hematologic toxicity, hematologic toxicity, and Non-hematologic (laboratory) toxicities
Duration of Response (DOR)
will be defined as the time from the first documentation of an objective tumor response (CR or PR) to the first documentation of tumor progression or to death due to any cause, whichever comes first, whichever comes first as defined by RECIST version 1.1.
Disease Control Rate (DCR)
DCR will be defined as the proportion of patients with best overall response of CR, PR, or stable disease (SD), whichever comes first as defined by RECIST version 1.1.
To evaluate the antitumor activity of MBRC-201 at the RP2D
Investigator-assessed ORR by RECIST v1.1
To evaluate preliminary antitumor activity of MBRC-201 at potential RP2D, OBRDs, and dosing regimens
Investigator-assessed ORR by Response Evaluation Criteria in Solid Tumor (RECIST) v1.1
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