Phase I study of TQB3602, an oral proteasome inhibitor, in relapsed and refractory multiple myeloma.

ABSTRACT:

Objective

TQB3602 is a novel orally bioavailable proteasome inhibitor. This study is the first-in-human phase I clinical trial to evaluate the safety, tolerability, pharmacokinetics, and preliminary efficacy of TQB3602 in relapsed/refractory multiple myeloma (RRMM).

Methods

This is a multicenter phase I clinical trial consisting of the 3+3 dose-escalation phase and dose expansion phase. Patients with MM who have received ≥2 prior antimyeloma therapies were enrolled. TQB3602 is administered at a dose of 0.5~7mg on days 1, 8, 15 in 28-day cycle.

Results

Twenty-five RRMM patients who relapsed or failed ≥2 lines of therapies were enrolled in the dose escalation phase. Two patients in the 7.0 mg dose group developed dose-limiting toxicity events (one with grade 2 periphera

SUBMITTER: Tang W 

PROVIDER: S-EPMC11259557 | biostudies-literature | 2024 Jul

REPOSITORIES: biostudies-literature