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Phase I Study of MIK665, a Mcl-1 Inhibitor, in Patients With Refractory or Relapsed Lymphoma or Multiple Myeloma

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

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02992483
Enrollment
31
Registered
2016-12-14
Start date
2017-07-12
Completion date
2019-06-07
Last updated
2021-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Multiple Myeloma (MM), Lymphoma, Large B-Cell, Diffuse (DLBCL), Lymphoma

Keywords

multiple myeloma, lymphoma, dlbcl

Brief summary

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.

Detailed description

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.

Interventions

DRUGMIK665

MIK665

Sponsors

Novartis Pharmaceuticals
Lead SponsorINDUSTRY

Study design

Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Age ≥ 18 years. * Histologically confirmed lymphoma (WHO classification), or confirmed MM (IMWG), that is relapsed and/or refractory. * Other Inclusion Criteria May Apply.

Exclusion criteria

* Known history of chronic liver disease * History of chronic pancreatitis. * Prior treatment with Mcl-1 inhibitor. * Other

Design outcomes

Primary

MeasureTime frame
Incidence and severity of AEs and SAEs, incl. changes in laboratory parameters, vital signs and ECGs.2 years
Incidence of DLTs during the first cycle of treatment with single agent MIK665 during the dose escalation phase only2 years
Tolerability: Dose interruptions2 years
Tolerability: Dose reductions2 years
Tolerability: Dose intensity2 years

Secondary

MeasureTime frameDescription
Apparent volume of distribution (Vz)2 yearsPlasma PK parameter
Duration of Response (DOR)per International Myeloma Working Group (IMWG) criteria for Myeloma; and per revised criteria for staging of the International Working Group (IWG) guidelines for Lymphoma2 years—
Progression Free Survival (PFS) per International Myeloma Working Group (IMWG) criteria for Myeloma; and per revised criteria for staging of the International Working Group (IWG) guidelines for Lymphoma2 years—
Clearance (CL)2 yearsPlasma PK parameter
Best Overall response (BOR) per International Myeloma Working Group (IMWG) criteria for Myeloma; and per revised criteria for staging of the International Working Group (IWG) guidelines for Lymphoma2 years—
Area Under Curve (AUC)2 yearsPlasma PK parameter
Maximum Plasma Concentration (Cmax)2 yearsPlasma PK parameter
Terminal elimination half-life (T1/2)2 yearsPlasma PK parameter

Countries

Australia, France, Germany, Italy, Japan, Spain, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 5, 2026