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CDX-527

Phase 1

Non-small Cell Lung Cancer | Small molecule | Oncology |Celldex Therapeutics, Inc.|Last Updated: Jun 18, 2023

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 Enrollment27
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT04440943A Study of the PD-L1xCD27 Bispecific Antibody CDX-527 in Patients With Advanced MalignanciesPHASE1 COMPLETED 27Aug 4, 2020Apr 6, 2023Jun 18, 20235 United States
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Study Endpoints
Primary Endpoints
Safety and Tolerability of CDX-527 as assessed by CTCAE v5.0
From first dose through 28 days after last dose

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

Secondary Endpoints
Objective Response Rate
Every 8 weeks starting with first dose until disease progression, assessed up to approximately 1-2 years.
Clinical Benefit Rate
Every 8 weeks, starting with first dose until disease progression, assessed up to approximately 1-2 years.
Duration of Response
First occurrence of a documented objective response to disease progression or death (up to approximately 1-2 years)
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
CDX-527EXPERIMENTALDose-escalation phase: Eligible patients will receive CDX-527 treatment based on cohort assigned until progression or intolerance. Expansion phase: Patients will receive CDX-527 at the dose level(s) chosen during the escalation phase.
Interventions
NameTypeDescription
CDX-527DRUGCDX-527 is administered by infusion every 2 weeks
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites5

Key Inclusion Criteria: 1. Recurrent, locally advanced or metastatic solid tumor cancer excluding the following: MSI-low colorectal cancer, glioblastoma multiforme, prostate cancer, pancreatic cancer, mucosal and ocular melanoma. 2. Receipt of all standard therapies for the tumor type 3. Measurable...

Countries:United States
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Competitive Landscape -Non-Small Cell Lung Cancer 406 trials
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Eli Lilly and CompanyLLY19PHASE3Selpercatinib, Carboplatin, Cisplatin, Pemetrexed, Pembrolizumab
AbbVie, Inc.ABBV10PHASE3Telisotuzumab Vedotin, Docetaxel, Telisotuzumab vedotin, Telisotuzumab Adizutecan, Livmoniplimab
Bristol-Myers Squibb CompanyBMY20PHASE3Repotrectinib, Crizotinib, Nivolumab, Carboplatin, Cisplatin
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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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