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NC410

Phase 1

Advanced or Metastatic Solid Tumors | Small molecule | Oncology |NextCure, Inc.|Last Updated: Dec 16, 2024

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
UNCONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment97
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT05572684A Safety, Tolerability and Efficacy Study of NC410 Plus Pembrolizumab in Participants with Advanced Unresectable or Metastatic Solid TumorsPHASE1 ACTIVE NOT_RECRUITING 97Oct 6, 2022Nov 1, 2025Dec 16, 202417 United States
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Study Endpoints
Primary Endpoints
Number of participants with treatment-emergent adverse events as assessed by CTCAE v5.0
24 Months

Frequency, duration, and severity of treatment-emergent adverse events (AEs)

Define a recommended Phase 2 dose (RP2D) of NC410 when combined with standard dose Pembrolizumab
42 days

A mTPI design will be utilized to determine the RP2D of NC410

Secondary Endpoints
Objective Response Rate per RECIST
until disease progression, up to 24 months
Duration of Response per RECIST
until disease progression, up to 24 months
Disease Control Rate per RECIST
until disease progression, up to 24 months
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
NC410 and pembrolizumabEXPERIMENTALAll participants will receive NC410 (IV) and pembrolizumab (IV) according to the treatment schedule until a reason for treatment discontinuation is reached.
Interventions
NameTypeDescription
NC410DRUGNC410 will be given intravenously (IV) every 2 weeks
pembrolizumabDRUGPembrolizumab 400mg will be given IV every 6 weeks.
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites17

Inclusion Criteria: * Be 18 years of age on day of signing informed consent. * Participant with histologically or cytologically confirmed diagnosis of the following advanced unresectable and/or metastatic solid tumors: * Phase 1b: Participants with solid tumors that are known to be associated as...

Countries:United States
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Recent Changes (Last 90 Days)
LOWMay 26, 2026NCT05572684primaryCompletionDate: changed
LOWMay 24, 2026NCT05572684studyFirstPostDate: changed