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INCB106385

Phase 1

Ovarian Cancer | Small molecule | Oncology |Incyte Corporation|Last Updated: Jul 11, 2025

Success Probability

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Market & Valuation

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Trial Design

CONTROLLED
Total Trials1
Total Enrollment54

FDA Designations

No designations recorded

Clinical trial landscape

INCB106385 · 1 trial · 11 indications

Phase 1 1
NCT04580485INCB106385 Alone or in Combination With Immunotherapy in Advanced Solid TumorsOvarian Cancer
COMPLETED54 Analytics
PHASE1COMPLETED
INCB106385 Alone or in Combination With Immunotherapy in Advanced Solid Tumors
Ovarian CancerUnlock trial analytics

Study Endpoints

Primary Endpoints

Number of treatment-emergent adverse events (TEAE)
Up to Approximately 28 months

Defined as any adverse event either reported for the first time or worsening of a pre-existing event after first dose of study drug up to 90 days after last dose of study drug.

Secondary Endpoints

Cmax of INCB106385 as a single agent or in combination with INCMGA00012
Up to 6 months
Tmax of INCB106385 as a single agent or in combination with INCMGA00012
Up to 6 months
Cmin of INCB106385 as a single agent or in combination with INCMGA00012
Up to 6 months
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Treatment Group A (TGA) - INCB106385EXPERIMENTALIn part 1 dose escalation, the dose levels will be escalated following a BOIN design. In part 2 dose expansion, participants will be assigned to different groups based on their tumor types and treated at the RDE.
Treatment Group B (TGB) - INCB106385+INCMGA00012EXPERIMENTALIn part 1 dose escalation, the dose levels will be escalated following a BOIN design. In part 2 dose expansion, participants will be assigned to different groups based on their tumor types and treated at the RDE.

Interventions

NameTypeDescription
INCB106385DRUGINCB106385 will be administered orally QD
INCMGA00012DRUGINCMGA0012 will be administered IV once every 4 weeks (Q4W)
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites27

Inclusion Criteria: * Ability to comprehend and willingness to sign an ICF. * Willing and able to conform to and comply with all Protocol requirements. * Histologically or cytologically confirmed advanced/metastatic SCCHN, NSCLC, ovarian cancer, TNBC, CRPC, bladder cancer, and specified GI malignan...

Countries:United StatesBelgiumFranceItalySpainUnited Kingdom
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Competitive Landscape -Ovarian Cancer 176 trials

Top 20 of 59 competitors

CompanyTickerTrialsLead PhaseDrugs
Merck & Co., Inc.MRK5PHASE3Pembrolizumab, Paclitaxel, Bevacizumab, Docetaxel
AstraZeneca PLCAZN19PHASE3Olaparib
GSK plc Sponsored ADRGSK4PHASE3Niraparib
Eli Lilly and CompanyLLY8PHASE3Sofetabart Mipitecan, Paclitaxel, Topotecan, Gemcitabine, Pegylated liposomal doxorubicin
AbbVie, Inc.ABBV13PHASE3Mirvetuximab soravtansine plus Bevacizumab, Bevacizumab
Bristol-Myers Squibb CompanyBMY4PHASE3Rucaparib, Nivolumab
Genmab A/S Sponsored ADRGMAB5PHASE3Rina-S, Paclitaxel, Topotecan, Pegylated liposomal doxorubicin, Gemcitabine
Pfizer Inc.PFE4PHASE3Avelumab, Lorlatanib, Talazoparib, Pemetrexed, Axitinib
Corcept Therapeutics Incorporated.CORT2PHASE3Nab-paclitaxel/m^2, Relacorilant once daily
Verastem, Inc.VSTM4PHASE3avutometinib, Defactinib, Pegylated liposomal doxorubicin, Paclitaxel, Letrozole
Zentalis Pharmaceuticals, Inc.ZNTL3PHASE3Azenosertib
Imunon, Inc.IMNN3PHASE3IMNN-001, Paclitaxel, Carboplatin, Olaparib, Niraparib
Incyte CorporationINCY2PHASE3INCB123667
Genelux Corp.GNLX1PHASE3olvimulogene nanivacirepvec, Platinum chemotherapy: carboplatin or cisplatin, Non-platinum chemotherapy: Physician's Choice of gemcitabine, taxane or pegylated liposomal doxorubicin, Bevacizumab
Regeneron Pharmaceuticals, Inc.REGN4PHASE2Ubamatamab, Bevacizumab, Cemiplimab, Fianlimab, PLD
Novartis AG Sponsored ADRNVS4PHASE2Dabrafenib, Trametinib
BeOne Medicines Ltd. Sponsored ADRONC2PHASE3Pamiparib
IQVIA Holdings IncIQV1PHASE3Oregovomab, Paclitaxel, Carboplatin
Xencor, Inc.XNCR3PHASE2vudalimab
Exelixis, Inc.EXEL2PHASE2Cabozantinib
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Frequently asked questions about INCB106385

What is INCB106385 used for?

INCB106385 is an investigational small molecule being studied for the treatment of advanced solid tumors, including ovarian cancer. It is being evaluated alone or in combination with immunotherapy in a Phase 1 clinical trial.

What does INCB106385 target?

The specific molecular target of INCB106385 has not been disclosed. It is a small molecule being studied in combination with immunotherapy for advanced solid tumors, including ovarian cancer.

Who makes INCB106385?

INCB106385 is being developed by Incyte Corporation, a biopharmaceutical company traded on the NASDAQ under the ticker symbol INCY.

What phase is INCB106385 in?

INCB106385 is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. A Phase 1 trial has been completed.

What clinical trials is INCB106385 in?

INCB106385 has been studied in a Phase 1 clinical trial, NCT04580485, which evaluated the drug alone or in combination with immunotherapy in advanced solid tumors. The trial enrolled 54 participants and has been completed.

Is INCB106385 the same as any other drug?

No alternative names for INCB106385 have been disclosed. It is identified solely by its investigational code name.