drugset / Trial / NCT03138538
M8891 First in Human in Solid Tumors
Phase 1
Terminated
27 enrolled
EMD Serono Research & Development Institute, Inc.
Merck KGaA, Darmstadt, Germany · collab
NaSingle-groupOpen-labelTreatment
Summary
The purpose of this study was to determine the maximum tolerated dose (MTD), safety, tolerability, Pharmacokinetic (PK), pharmacodynamic and clinical activity of M8891 as single agent in participants with advanced solid tumors in Part 1.
Timeline
- Start
- 2017-08-08
- Primary completion
- 2020-09-16
- Completion
- 2020-09-16
Outcome
Outcome not reported
Stopped (Business): “As part of a portfolio-level management of the company's oncology pipeline, it was decided to stop the next phase of internal development of the MetAP2 (M8891) program to enable realization of other opportunities within the oncology portfolio.”
Publications
- Lignet F, Friese-Hamim M, Jaehrling F, El Bawab S, Rohdich F. Preclinical Pharmacokinetics and Translational Pharmacokinetic/Pharmacodynamic Modeling of M8891, a Potent and Reversible Inhibitor of Methionine Aminopeptidase 2. Pharm Res. 2023 Dec;40(12):3011-3023. doi: 10.1007/s11095-023-03611-z. Epub 2023 Oct 5.
- Carducci MA, Wang D, Habermehl C, Bodding M, Rohdich F, Lignet F, Duecker K, Karpenko O, Pudelko L, Gimmi C, LoRusso P. A First-in-human, Dose-escalation Study of the Methionine Aminopeptidase 2 Inhibitor M8891 in Patients with Advanced Solid Tumors. Cancer Res Commun. 2023 Aug 24;3(8):1638-1647. doi: 10.1158/2767-9764.CRC-23-0048. eCollection 2023 Aug.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | M8891 | Unknown | 7 mg | Oral |
| Subject | M8891 | Unknown | 12 mg | Oral |
| Subject | M8891 | Unknown | 20 mg | Oral |
| Subject | M8891 | Unknown | 35 mg | Oral |
| Subject | M8891 | Unknown | 60 mg | Oral |
| Subject | M8891 | Unknown | 80 mg | Oral |