The purpose of this first in human study is to assess safety, tolerability, PK and
preliminary clinical activity and to estimate the MTD(s)/RDE(s) of MIK665 (also referred
as S64315) as single agent administered intravenously (i.v.) in adult patients with
refractory or relapsed lymphoma or multiple myeloma.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT02992483.
The design of this phase I, open label, dose finding study was chosen in order to
characterize the safety and tolerability of MIK665 and to determine the Maximal Tolerated
Dose(s) (MTD(s)) and/or Recommended Dose(s) for Expansion (RDE(s)).
This study will utilize a Bayesian Hierarchical model to guide dose escalation and
estimate the MTD(s) based on the dose-DLT relationship(s) for MIK665 in the indications.
The expansion part of the study will employ an open-label multiple arm design. The
purpose of the expansion part is to further assess safety, tolerability, PK, PD and the
anti-tumor activity of MIK665 at the selected RDE/s for Multiple Myeloma (MM) and MYC
positive Diffuse large B-Cell Lymphoma (DLBCL) identified in the dose-escalation part.
Lead OrganizationNovartis Pharmaceuticals Corporation
