First-in-Human Study of MS201408-0005A as Single Agent and in Combinations

Phase 1 Terminated 15 enrolled EMD Serono Research & Development Institute, Inc. Merck KGaA, Darmstadt, Germany · collab

Non-randomizedParallel-groupOpen-labelTreatment

Summary

This is a Phase I, open-label study to determine the safety, tolerability, pharmacokinetic (PK), pharmacodynamics (PD), and preliminary antitumor activity of MS201408-0005A as single agent (Part IA only) and in combination with MS201408-0005C or MS201408-0005B (Part IB, Part IC).

Timeline

Start: 2017-10-03
Primary completion: 2019-01-14
Completion: 2019-01-14

Outcome

Outcome not reported

Stopped: “The study was terminated early due to lackluster pharmacodynamic data that showed no significant reduction of plasma kynurenine at steady state of M4112.”

Publications

Naing A, Eder JP, Piha-Paul SA, Gimmi C, Hussey E, Zhang S, Hildebrand V, Hosagrahara V, Habermehl C, Moisan J, Papadopoulos KP. Preclinical investigations and a first-in-human phase I trial of M4112, the first dual inhibitor of indoleamine 2,3-dioxygenase 1 and tryptophan 2,3-dioxygenase 2, in patients with advanced solid tumors. J Immunother Cancer. 2020 Aug;8(2):e000870. doi: 10.1136/jitc-2020-000870.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	M4112	Unknown	100 mg	Oral
Subject	M4112	Unknown	200 mg	Oral
Subject	M4112	Unknown	400 mg	Oral
Subject	M4112	Unknown	600 mg	Oral
Subject	M4112	Unknown	800 mg	Oral