First-in-Human Dose Escalation Trial in Subjects With Advanced Malignancies

NCT01971515 ↗

Phase 1 Completed 101 enrolled EMD Serono

Non-randomizedSingle-groupOpen-labelTreatment

Summary

This is a Phase 1, first-in-human, open-label, non-randomized, dose escalation, trial to explore the safety, tolerability, pharmacokinetic (PK), pharmacodynamic (PD) and clinical activity signals of MSC2363318A.

Timeline

Start: 2013-12-13
Primary completion: 2018-08-09
Completion: 2018-08-09

Publications

Tsimberidou AM, Shaw JV, Juric D, Verschraegen C, Weise AM, Sarantopoulos J, Lopes G, Nemunaitis J, Mita M, Park H, Ellers-Lenz B, Tian H, Xiong W, Kaleta R, Kurzrock R. Phase 1 study of M2698, a p70S6K/AKT dual inhibitor, in patients with advanced cancer. J Hematol Oncol. 2021 Aug 18;14(1):127. doi: 10.1186/s13045-021-01132-z.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	RUPITASERTIB	Small molecule	160 mg	Oral
Subject	RUPITASERTIB	Small molecule	240 mg	Oral
Background	Tamoxifen	Small molecule	—	Oral
Background	Trastuzumab	Monoclonal antibody	—	Intravenous

First-in-Human Dose Escalation Trial in Subjects With Advanced Malignancies

Summary

Timeline

Publications

Drugs

Indications