Phase I Open Label, Multi-center Study to Characterize the Safety, Tolerability and Pharmacokinetics of Intravenously Administered MIK665, a Mcl-1 Inhibitor, in Patients With Refractory or Relapsed Lymphoma or Multiple Myeloma
All compounds are either investigational or being studied for (a) new use(s). Efficacy and safety have not been established. There is no guarantee that they will become commercially available for the use(s) under investigation.
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.
Multiple Myeloma (MM), Lymphoma, Large B-Cell, Diffuse (DLBCL), Lymphoma
Sep 09, 2020
Jul 12, 2017
May 31, 2021
18 Years and older (Adult, Older Adult)
Age ≥ 18 years.
Histologically confirmed lymphoma (WHO classification), or confirmed MM (IMWG), that is relapsed and/or refractory.
Other Inclusion Criteria May Apply.
Known history of chronic liver disease
History of chronic pancreatitis.
Prior treatment with Mcl-1 inhibitor.
Other Exclusion Criteria May Apply.
Ohio State University Medical Center Main Site
MD Anderson Cancer Center/University of Texas MD Anderson CC