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CDX-585

Phase 1

Non-small Cell Lung Cancer | Small molecule | Oncology |Celldex Therapeutics, Inc.|Last Updated: Jun 15, 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
UNCONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment20
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT05788484A Study of CDX-585 in Patients With Advanced MalignanciesPHASE1 COMPLETED 20May 11, 2023May 21, 2025Jun 15, 20254 United States
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Study Endpoints
Primary Endpoints
Dose escalation: To determine the maximum tolerated dose of CDX-585 and to select the CDX-585 dose(s) for evaluation in tumor-specific expansion cohorts
Approximately 12 months

The rates of drug-related adverse events will be summarized, and maximum tolerated dose will be determined.

Tumor-specific expansion cohorts: To further evaluate the safety of CDX-585 by tumor type.
Approximately 6 months

The rates of drug-related adverse events will be summarized, and further evaluated in specific tumor types.

Secondary Endpoints
Safety and Tolerability of CDX-585 as assessed by CTCAE v5.0
From first dose through 90 days after last dose
Objective Response Rate
Assessed up to approximately 1-3 years.
Clinical Benefit Rate
Assessed up to approximately 1-3 years.
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
CDX-585EXPERIMENTALDose-escalation phase: Eligible patients will receive treatment, based on cohort assigned, in 2-week cycles until progression or intolerance. Expansion phase: Patients enrolled in the expansion phase of the study will receive CDX-585 at the dose level chosen during the escalation phase.
Interventions
NameTypeDescription
CDX-585DRUGCDX-585 is administered by infusion every 2 weeks
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites4

Key Inclusion Criteria: 1. Recurrent, locally advanced, or metastatic solid tumor cancer excluding primary central nervous system tumors (e.g., glioblastoma). 2. Receipt of standard therapy for the tumor type in the recurrent, locally advanced, or metastatic setting. 3. Measurable (target) disease ...

Countries:United States
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Competitive Landscape -Non-Small Cell Lung Cancer 406 trials
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Revolution Medicines, Inc.RVMD8PHASE3daraxonrasib, docetaxel, RMC-6291, Elironrasib, Daraxonrasib
Eli Lilly and CompanyLLY19PHASE3Selpercatinib, Carboplatin, Cisplatin, Pemetrexed, Pembrolizumab
AbbVie, Inc.ABBV10PHASE3Telisotuzumab Vedotin, Docetaxel, Telisotuzumab vedotin, Telisotuzumab Adizutecan, Livmoniplimab
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Pfizer Inc.PFE21PHASE3Lorlatinib, Crizotinib, Avelumab, Lorlatanib, Talazoparib
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Summit Therapeutics IncSMMT2PHASE3Ivonescimab, Pembrolizumab
Nuvation Bio, Inc. Class ANUVB4PHASE3Taletrectinib, Crizotinib, AB-106
Genmab A/S Sponsored ADRGMAB4PHASE3Acasunlimab, Pembrolizumab, Docetaxel, Rina-S, GEN1042
Incyte CorporationINCY1PHASE3Retifanlimab, Pemetrexed, Cisplatin, Carboplatin, Paclitaxel
Regeneron Pharmaceuticals, Inc.REGN6PHASE2cemiplimab, Platinum Doublet, fianlimab, Pemetrexed, Paclitaxel
BeOne Medicines Ltd. Sponsored ADRONC6PHASE3Tislelizumab, Cisplatin, Paclitaxel, Pemetrexed Disodium, Carboplatin
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