This record was last updated March 2, 2026 (before its estimated July 2026 completion). Its status may not reflect the trial's current state.
Summary
This is a first-in-human (FIH), open label Phase 1/1b / Phase 2 study in patients with advanced metastatic solid tumors refractory to standard treatment. Phase 1 will identify potential optimal biologically relevant doses (OBRD) and the maximum tolerated dose (MTD) of MBRC-101 at one 1 or more dosing regimens. Phase 1b will evaluate the safety and preliminary clinical activity of MBRC-101 at potential OBRDs. Phase 1 and Phase 1b will both characterize single and multiple-dose PK profiles and evaluate incidence and persistence of anti-MBRC-101 Ab. Phase 2 will evaluate the efficacy of MBRC-101 at the RP2D from Phase1b.
Protocol Amendment History
17 amendments
This ClinicalTrials.gov record has been amended 17 times since 2023-08-23; most recent amendment 2026-02-26.
Status change: Not Yet Recruiting → Recruiting2023-10-11