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NXP800

Phase 1

Advanced Solid Tumor | Small molecule | Oncology |Nuvectis Pharma, Inc.|Last Updated: Aug 8, 2025

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
CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment45
FDA Designations
ORPHAN_DRUGFAST_TRACK
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT05226507A Phase 1 Clinical Study of NXP800 in Subjects With Advanced Cancers and Expansion in Subjects With Ovarian CancerPHASE1 ACTIVE NOT_RECRUITING 45Dec 31, 2021Dec 1, 2025Aug 8, 202522 United States, United Kingdom
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Study Endpoints
Primary Endpoints
Part A: Number of patients with treatment related adverse events, clinical laboratory abnormalities, dose limiting toxicities
Day 28
Part B: Estimates of disease response by RECIST v 1.1
Baseline to 30 days post last dose of NXP800
Part B: Number of patients with treatment related adverse events, and/or clinical laboratory abnormalities.
Baseline to 30 days post last dose of NXP800
Secondary Endpoints
Area under the concentration-time curve (AUC) of NXP800
First dose through Day 29
Maximum observed concentration (Cmax) of NXP800
First dose through Day 29
Time to peak concentration (Tmax) of NXP800
First dose through Day 29
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelSEQUENTIAL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Part A: Dose EscalationEXPERIMENTALEscalating doses of NXP800 administered orally once or twice daily.
Part B: Expansion in Ovarian Cancers Cohort 1EXPERIMENTALSubjects will be treated with NXP800 at 50 mg/day orally.
Part B: Expansion in Ovarian Cancers Cohort 2EXPERIMENTALSubjects will be treated with NXP800 at 75 mg/day orally.
Interventions
NameTypeDescription
NXP800DRUGNXP800 is an anti-neoplastic, oral small molecule.
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites22

Part A Inclusion Criteria: * Provide written informed consent. * 18 years old or older. * Life expectancy of at least 12 weeks. * Histologically- or cytologically-confirmed, advanced, metastatic, and/or progressive solid tumors for whom there is no authorized or effective therapy available, or for ...

Countries:United StatesUnited Kingdom
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Recent Changes (Last 90 Days)
LOWMay 26, 2026NCT05226507primaryCompletionDate: changed
LOWMay 24, 2026NCT05226507studyFirstPostDate: changed