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MIK665

Phase 1

Multiple Myeloma (MM), Lymphoma, Large B-Cell, Diffuse (DLBCL), Lymphoma | Small molecule | Oncology |Novartis AG|Last Updated: Aug 3, 2021

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment31

FDA Designations

No designations recorded

Clinical trial landscape

MIK665 · 1 trial · 1 indication

Phase 1 1
NCT02992483Phase I Study of MIK665, a Mcl-1 Inhibitor, in Patients With Refractory or Relapsed Lymphoma or Multiple MyelomaMultiple Myeloma (MM), Lymphoma, Large B-Cell, Diffuse (DLBCL), Lymphoma
COMPLETED31 Analytics
PHASE1COMPLETED
Phase I Study of MIK665, a Mcl-1 Inhibitor, in Patients With Refractory or Relapsed Lymphoma or Multiple Myeloma
Multiple Myeloma (MM), Lymphoma, Large B-Cell, Diffuse (DLBCL), Lymphoma
NCT0299248331
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Study Endpoints

Primary Endpoints

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 only
2 years
Tolerability: Dose interruptions
2 years
Tolerability: Dose reductions
2 years
Tolerability: Dose intensity
2 years

Secondary Endpoints

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 Lymphoma
2 years
Area Under Curve (AUC)
2 years
Maximum Plasma Concentration (Cmax)
2 years
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
MIK665EXPERIMENTAL -

Interventions

NameTypeDescription
MIK665DRUGMIK665
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites8

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 t...

Countries:United StatesAustraliaFranceGermanyItalyJapanSpain
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Frequently asked questions about MIK665

What is MIK665 used for?

MIK665 is an investigational small molecule being studied for the treatment of multiple myeloma (MM), diffuse large B-cell lymphoma (DLBCL), and lymphoma. It is being developed by Novartis AG for use in oncology. As of the available data, MIK665 is in Phase 1 clinical development and has not been approved by regulatory authorities.

What does MIK665 target?

MIK665 is a Mcl-1 inhibitor, meaning it targets the Mcl-1 protein, which is involved in cancer cell survival. By inhibiting Mcl-1, the drug aims to induce apoptosis in cancer cells. This mechanism is being investigated in patients with relapsed or refractory lymphoma and multiple myeloma.

Who makes MIK665?

MIK665 is being developed by Novartis AG, a multinational pharmaceutical company listed on the New York Stock Exchange under the ticker symbol NVS. The drug is currently in Phase 1 clinical trials for the treatment of multiple myeloma and lymphoma.

What phase is MIK665 in?

MIK665 is in Phase 1 clinical development. It is an investigational drug and has not been approved by the FDA or any other regulatory agency. The drug is being studied in patients with relapsed or refractory lymphoma or multiple myeloma, and the Phase 1 trial has been completed.

What clinical trials is MIK665 in?

MIK665 has been studied in a Phase 1 clinical trial with the identifier NCT02992483. This trial was a single-arm, uncontrolled study that enrolled 31 patients with relapsed or refractory lymphoma or multiple myeloma. The trial was conducted in the United States, Australia, France, Germany, Italy, Japan, and Spain, and has been completed.

Is MIK665 the same as any other drug?

MIK665 is a unique investigational compound and no alternative names have been reported. It is a small molecule Mcl-1 inhibitor developed by Novartis AG. The drug is being studied specifically for its potential in treating multiple myeloma and lymphoma, and it is not known to be identical to any other approved or investigational drug.