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INCAGN02390

Phase 1

Cervical Cancer | Small molecule | Oncology |Incyte Corporation|Last Updated: Nov 15, 2021

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment40

FDA Designations

No designations recorded

Clinical trial landscape

INCAGN02390 · 1 trial · 21 indications

Phase 1 1
NCT03652077A Safety and Tolerability Study of INCAGN02390 in Select Advanced MalignanciesCervical Cancer
COMPLETED40 Analytics
PHASE1COMPLETED
A Safety and Tolerability Study of INCAGN02390 in Select Advanced Malignancies
Cervical CancerUnlock trial analytics

Study Endpoints

Primary Endpoints

Number of treatment-emergent adverse events
Up to 12 months

Adverse events reported for the first time or worsening of a pre-existing event after first dose of study drug.

Maximum tolerated dose or pharmacologically active dose (PAD) of INCAGN02390 (Part 1 only)
Up to approximately 1 month

PAD defined as a dose that achieves a level of receptor occupancy considered to be biologically active.

Secondary Endpoints

Cmax of INCAGN02390
Up to 12 months
Tmax of INCAGN02390
Up to 12 months
Cmin of INCAGN02390
Up to 12 months
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
INCAGN02390EXPERIMENTAL -

Interventions

NameTypeDescription
INCAGN02390DRUGPart 1: INCAGN02390 at the protocol-defined starting dose administered every 2 weeks (Q2W), with dose escalation in 7 total cohorts to determine the maximum tolerated dose or PAD.
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites4

Inclusion Criteria: * Participants with locally advanced or metastatic tumors who are not eligible for any available therapy likely to convey clinical benefit (locally advanced disease must not be amenable to resection with curative intent). * Participants who have disease progression after treatme...

Countries:United States
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Competitive Landscape -Cervical Cancer 64 trials

Frequently asked questions about INCAGN02390

What is INCAGN02390 used for in cervical cancer?

INCAGN02390 is an investigational small molecule being studied for the treatment of cervical cancer. It is currently in Phase 1 clinical development and is not yet approved by the FDA. The drug is being evaluated for safety and tolerability in patients with select advanced malignancies, including cervical cancer.

Who makes INCAGN02390?

INCAGN02390 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 drug's safety and tolerability in patients with advanced malignancies.

What phase is INCAGN02390 in?

INCAGN02390 is in Phase 1 clinical development. It is an investigational drug and has not received FDA approval. A Phase 1 trial has been completed to assess its safety and tolerability in patients with select advanced malignancies, including cervical cancer.

What clinical trials is INCAGN02390 in?

INCAGN02390 has one completed clinical trial, identified as NCT03652077. This Phase 1 study evaluated the safety and tolerability of INCAGN02390 in select advanced malignancies, including cervical cancer, and enrolled 40 participants in the United States.

Is INCAGN02390 FDA approved?

INCAGN02390 is not FDA approved. It is an investigational drug currently in Phase 1 clinical development. A Phase 1 trial has been completed to evaluate its safety and tolerability, but the drug has not yet been approved for any indication.