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ARGX-111

Phase 1

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

ARGX-111 development status

Highest phase Phase 1
Registered trials 1 across 1 sponsor since Feb 2014

ARGX-111 target and mechanism

Molecular targetMET
ModalitySmall molecule

Success Probability

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Market & Valuation

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Trial Design

CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment24

FDA Designations

No designations recorded

ARGX-111 clinical trials

ARGX-111 · 1 trial · 1 indication

Phase 1 1
NCT02055066A Phase 1b Study of ARGX-111 in Patients With Advanced Cancer.Cancer
COMPLETED24 Analytics
PHASE1COMPLETED
A Phase 1b Study of ARGX-111 in Patients With Advanced Cancer.
CancerUnlock trial analytics

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 to 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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Competitive Landscape -Cancer 7 trials

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Frequently asked questions about ARGX-111

What is ARGX-111 used for?

ARGX-111 is an investigational cancer therapy being studied in patients with advanced cancer. It was evaluated in a Phase 1b trial in Belgium that enrolled 24 adults aged 18 and older. The study has been completed, and ARGX-111 is not an approved treatment.

What does ARGX-111 target?

ARGX-111 targets MET, a receptor tyrosine kinase involved in cell signaling. By binding MET, the small molecule is designed to interfere with signaling pathways that support tumor growth. The Phase 1b study in advanced cancer used biomarker selection to identify patients for enrollment.

Who is developing ARGX-111?

ARGX-111 is being developed by argenx SE, a biotechnology company whose shares trade under the ticker ARGX. The company sponsored the Phase 1b study of ARGX-111 in patients with advanced cancer, which was conducted in Belgium.

What phase is ARGX-111 in?

ARGX-111 is in Phase 1 development. Its only recorded clinical trial is a completed Phase 1b study in advanced cancer that enrolled 24 patients. ARGX-111 is investigational and has not been approved for any indication.

What clinical trials is ARGX-111 in?

ARGX-111 has been studied in one clinical trial, NCT02055066, titled A Phase 1b Study of ARGX-111 in Patients With Advanced Cancer. The trial enrolled 24 adults, was conducted in Belgium, and is now completed. No active trials of ARGX-111 are currently listed.