A Multicenter, Open-label Phase 1/2 Dose Finding, Safety, and Pharmacokinetic Study of MBRC-201, an Antibody-drug Conjugate, in Advanced Refractory Solid Tumors
MBrace Therapeutics
Summary
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.
Description
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. Phase 1a will characterize safety and identify potential optimal biologically relevant doses (OBRDs), Recommended Phase 2 Doses (RP2Ds), and the maximum tolerated dose (MTD) of MBRC-201 at one or more dosing regimens. Phase 1b will evaluate the safety and preliminary clinical activity of MBRC-201 at the potential OBRDs, RP2Ds, and dosing regimens identified in Phase 1a. The initial Phase 2 portion wi…