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INCAGN02390

Phase 1

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

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment40
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT03652077A Safety and Tolerability Study of INCAGN02390 in Select Advanced MalignanciesPHASE1 COMPLETED 40Sep 24, 2018Aug 18, 2021Nov 15, 20214 United States
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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 — 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 68 trials
CompanyTickerTrialsLead PhaseDrugs
AstraZeneca PLCAZN5PHASE3Volrustomig, Cisplatin, Carboplatin, Paclitaxel, 5-FU
Merck & Co., Inc.MRK4PHASE3Sacituzumab Tirumotecan, Pemetrexed, Tisotumab Vedotin, Topotecan, Vinorelbine
Pfizer Inc.PFE3PHASE2tucatinib, trastuzumab, fulvestrant, TG4001, Avelumab
ImmunityBio IncIBRX2PHASE2N-803 + Pembrolizumab, IBRX-042
Eli Lilly and CompanyLLY3PHASE1LY4101174, LY4052031, LY4170156, bevacizumab, carboplatin
MacroGenics, Inc.MGNX2PHASE2Lorigerlimab, MGC026 Dose Escalation
Precigen IncPGEN1PHASE2PRGN-2009 plus Pembrolizumab
Xencor, Inc.XNCR1PHASE2vudalimab
Incyte CorporationINCY1PHASE2Chemotherapy, Retifanlimab
Iovance Biotherapeutics IncIOVA3PHASE2E7 TCR-T cells, Aldesleukin, KK-LC-1 TCR-T cells
Bristol-Myers Squibb CompanyBMY1PHASE1BMS-986340, BMS-936558-01, Docetaxel, Pumitamig
AbbVie, Inc.ABBV1PHASE1IMGN151
Arcus Biosciences, Inc.RCUS1PHASE1AB598, Zimberelimab, Fluorouracil, Leucovorin, Oxaliplatin
Ascendis Pharma A/SASND1PHASE1TransCon IL-2 β/γ, Pembrolizumab, Chemotherapy drug, TransCon TLR7/8 Agonist, Trastuzumab
Nanobiotix SA Sponsored ADRNBTX1PHASE1NBTXR3, Nivolumab, Pembrolizumab
TScan Therapeutics, Inc.TCRX2PHASE1TSC-204-A0201, TSC-204-C0702, TSC-200-A0201, TSC-203-A0201, TSC-204-A0101
Oncolytics Biotech Inc.ONCY1PHASE1Pelareorep, Atezolizumab, Gemcitabine and nab-paclitaxel, Trifluridine Tipiracil, mFOLFIRINOX Treatment Regimen
Adlai Nortye Ltd. Sponsored ADRANL1PHASE1AN0025, Pembrolizumab
Nurix Therapeutics, Inc.NRIX1PHASE1NX-1607, Paclitaxel
Boundless Bio Inc.BOLD1PHASE1BBI-355, Erlotinib, Futibatinib, BBI-825
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