Safety and Efficacy of MAK683 in Adult Patients With Advanced Malignancies

Summary

The purpose of this Phase I/II study is to establish the maximum tolerated dose (MTD) and/or recommended phase 2 dose (RP2D) and to evaluate the safety, antitumor activity and pharmacokinetic (PK) profile of MAK683 in patients with advanced malignancies such as Diffuse Large B cell Lymphoma (DLBCL), nasopharyngeal carcinoma (NPC) or other advanced solid tumors for whom no further effective standard treatment is available.

Timeline

Start

2016-10-03

Primary completion

2024-10-09

Completion

2024-10-09

Outcome

Outcome not reported

Stopped (Business): “The decision of early termination was made due to business reasons, and was not based on any safety or tolerability concerns for MAK683”

Publications

• Ribrag V, Iglesias L, De Braud F, Ma B, Yokota T, Zander T, Spreafico A, Subbiah V, Illert AL, Tan D, Santoro A, Munster PN, Suehiro Y, Wang Y, Ji DM, Chen S, Beltz K, Suenaga N, Ramkumar T, Luo F, Lai C, Wainberg ZA. A first-in-human phase 1/2 dose-escalation study of MAK683 (EED inhibitor) in patients with advanced malignancies. Eur J Cancer. 2025 Feb 5;216:115122. doi: 10.1016/j.ejca.2024.115122. Epub 2024 Nov 16.

Drugs

Indications