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INCB053914

Phase 1

Relapsed Diffuse Large B-Cell Lymphoma | Small molecule | Oncology |Incyte Corporation|Last Updated: Nov 10, 2020

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment9

FDA Designations

No designations recorded

Clinical trial landscape

INCB053914 · 1 trial · 2 indications

Phase 1 1
NCT03688152A Safety and Tolerability Study of INCB053914 in Combination With INCB050465 in Diffuse Large B-Cell LymphomaRelapsed Diffuse Large B-Cell Lymphoma
COMPLETED9 Analytics
PHASE1COMPLETED
A Safety and Tolerability Study of INCB053914 in Combination With INCB050465 in Diffuse Large B-Cell Lymphoma
Relapsed Diffuse Large B-Cell LymphomaUnlock trial analytics

Study Endpoints

Primary Endpoints

Number of treatment-emergent adverse events (TEAEs)
Up to approximately 6 months

TEAE is defined as an adverse event reported for the first time or worsening of a pre-existing event after the first dose of study treatment.

Secondary Endpoints

Cmax of INCB053914 in combination with INCB050465
Day 15
Tmax of INCB053914 in combination with INCB050465
Day 15
Cmin of INCB053914 in combination with INCB050465
Day 15
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
INCB053914 + INCB050465EXPERIMENTALINCB053914 in combination with INCB050465.

Interventions

NameTypeDescription
INCB053914DRUGDose Escalation: INCB053914 at the protocol-defined starting dose in combination with INCB050465, with dose modifications based on tolerability criteria. Dose Expansion: Recommended dose from the dose-escalation study.
INCB050465DRUGDose Escalation: INCB050465 at the protocol-defined starting dose in combination with INCB053914, with dose modifications based on tolerability criteria. Dose Expansion: Recommended dose from the dose-escalation study.
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites3

Inclusion Criteria: * Relapsed or refractory DLBCL, which has been histologically documented, defined as having received at least 2 but no more than 5 prior systemic treatment regimens (eg, an anti-CD20 antibody, an anti-CD20 antibody with or without chemotherapy, or chemotherapy alone) and ineligi...

Countries:United States
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Frequently asked questions about INCB053914

What is INCB053914 used for?

INCB053914 is an investigational small molecule being studied for the treatment of relapsed diffuse large B-cell lymphoma (DLBCL). It is being evaluated in combination with another agent in patients with relapsed or refractory DLBCL. The drug is not approved and remains in clinical development.

Who makes INCB053914?

INCB053914 is being developed by Incyte Corporation, a biopharmaceutical company traded on the NASDAQ under the ticker symbol INCY. The company is conducting clinical trials to evaluate the safety and tolerability of this investigational drug in patients with relapsed or refractory diffuse large B-cell lymphoma.

What phase is INCB053914 in?

INCB053914 is in Phase 1 clinical development. A Phase 1 study has been completed, evaluating the drug in combination with INCB050465 in patients with relapsed or refractory diffuse large B-cell lymphoma. The drug is investigational and has not been approved by regulatory authorities.

What clinical trials is INCB053914 in?

INCB053914 has been studied in one clinical trial, identified as NCT03688152. This was a Phase 1, open-label, uncontrolled study conducted in the United States, evaluating the safety and tolerability of INCB053914 in combination with INCB050465 in patients with relapsed or refractory diffuse large B-cell lymphoma. The trial enrolled 9 participants and has been completed.

Is INCB053914 the same as INCB050465?

No, INCB053914 is not the same as INCB050465. INCB053914 is the investigational drug being studied, while INCB050465 is a separate agent used in combination with INCB053914 in the clinical trial. The study evaluated the safety and tolerability of the combination in patients with relapsed or refractory diffuse large B-cell lymphoma.