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ARGX-110

Phase 1

Cancer | Small molecule | Oncology |argenx SE|Last Updated: Aug 8, 2018

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
CONTROLLEDBiomarker
Total Trials1
Total Enrollment11
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT02759250A Study of ARGX-110 in Patients With Nasopharyngeal Carcinoma (NPC)PHASE1 COMPLETED 11 — — Feb 1, 2015Jun 1, 2018Aug 8, 20181 Belgium
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Study Endpoints
Primary Endpoints
Incidence and grading of AEs
measured at screening, Day 1, Day 8, Day 15, Day 42, thereafter every 42 days until Day 378

Change from baseline in incidence and grading of AEs according to the Common Terminology Criteria for Adverse Event (NCI-CTCAE) Version 4.03

Secondary Endpoints
Pharmacokinetic profile of ARGX110 by Cmax
measured at Day 1 pre and post dose, Day 8, Day 15, Day 42 pre and post dose and thereafter every 42 days until Day 378
Pharmacokinetic profile of ARGX110 by AUC
measured at Day 1 pre and post dose, Day 8, Day 15, Day 42 pre and post dose and thereafter every 42 days until Day 378
Biomarkers CD70 immunohistochemistry (IHC)
measured at Screening, Day 42, and thereafter every 42 days until day Day 378
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
adjuvant monotherapyEXPERIMENTALARGX-110 5mg/kg once every three weeks for a maximum of 18 cycles
metastatic/recurrent monotherapyEXPERIMENTALARGX-110 5mg/kg once every three weeks until disease progression
metastatic/recurrent combination therapyEXPERIMENTALARGX-110 5mg/kg once every three weeks plus chemotherapy until disease progression. The choice of the chemotherapy agents is limited to: cisplatin, carboplatin, 5-fluorouracil, gemcitabine and paclitaxel.
Interventions
NameTypeDescription
ARGX-110DRUG -
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion criteria: * Age ≥18 years. * Written informed consent prior to any study-related procedure * Willing and able to comply with protocol-specified procedures and scheduled evaluations * Pathological diagnosis of nasopharyngeal carcinoma (NPC) * Eastern Cooperative Oncology Group (ECOG) Perfo...

Countries:Belgium
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Competitive Landscape -Cancer 5 trials
CompanyTickerTrialsLead PhaseDrugs
GE Healthcare Technologies Inc.GEHC1PHASE1GEH200520 / GEH200521 - Part A
Zimmer Biomet Holdings, Inc.ZBH1 — Undisclosed
Ascentage Pharma Group International Unsponsored ADRAAPG1PHASE1Olverembatinib
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