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ARGX-111

Phase 1

Cancer | Small molecule | Oncology |argenx SE|Last Updated: Apr 21, 2017

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 Enrollment24
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT02055066A Phase 1b Study of ARGX-111 in Patients With Advanced Cancer.PHASE1 COMPLETED 24Jan 1, 2014Mar 1, 2017Apr 21, 20172 Belgium
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Study Endpoints
Primary Endpoints
Dose-limiting toxicity
1 month

Number of patients with grade 3 or 4 toxicity

Secondary Endpoints
Pharmacokinetic profiles (Cmax , Ctrough, AUC, Vd , clearance, and half-life)
C1 D1 (pre, 0h, 2h, 6h, 12h, 24h), C1D8, C1D15; Cycle ≥2 o D1 pre-/post-dose
Biomarkers (Hepatocyte growth factor; ADCC)
Base-line and pre-dose at each cycle for an average of 4 months
Incidence of adverse events per dose level
for an average of 4 months
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Arm 1EXPERIMENTALARGX-111 0.3 mg/kg
Arm 2EXPERIMENTALARGX-111 1.0 mg/kg
Arm 3EXPERIMENTALARGX-111 3.0 mg/kg
Arm 4EXPERIMENTALARGX-111 10 mg/kg
Interventions
NameTypeDescription
ARGX-111DRUG -
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites2

Inclusion Criteria: 1. Written informed consent. 2. Age ≥ 18 years. 3. Performance status of 0 or 1. 4. Histological diagnosis of malignancy. 5. Cancer relapsing after, or refractory to standard therapy. 6. Malignancy over-expressing the c Met protein. 7. Presence of circulating tumor cells (CTCs)....

Countries:Belgium
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