Safety, PK, and Preliminary Efficacy of MBRC-101 in Advanced Refractory Solid Tumors

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.

Timeline

Start

2023-11-07

Primary completion

2026-07

Completion

2026-11

Publications

• Staquicini FI, Tang FH, de Oliveira V, Kim SY, Chen ER, Markosian C, Staquicini DI, Wu Y, Parsons JK, Barnhart KF, Alley SC, Chen I, Arap W, Pasqualini R. First-generation and preclinical evaluation of an EphA5-targeted antibody-drug conjugate in solid tumors. J Clin Invest. 2025 Jul 15;135(14):e188492. doi: 10.1172/JCI188492. eCollection 2025 Jul 15.

Drugs

Indications