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ARGX-111

Phase 1

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

Success Probability

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Market & Valuation

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Trial Design

CONTROLLEDDMC
Total Trials1
Total Enrollment24

FDA Designations

No designations recorded

Clinical trial landscape

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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Frequently asked questions about ARGX-111

What is ARGX-111 used for?

ARGX-111 is an investigational small molecule being developed for the treatment of cancer. It is currently in Phase 1 clinical development, having completed a Phase 1b study in patients with advanced cancer. The drug is not yet approved and remains under investigation for its potential use in oncology.

Who makes ARGX-111?

ARGX-111 is being developed by argenx SE, a biopharmaceutical company traded on the stock exchange under the ticker ARGX. The company is conducting clinical research to evaluate the safety and efficacy of this investigational oncology drug.

What phase is ARGX-111 in?

ARGX-111 is in Phase 1 clinical development. A Phase 1b study of the drug in patients with advanced cancer has been completed. As an investigational agent, it has not yet received regulatory approval and is still in the early stages of clinical testing.

What clinical trials is ARGX-111 in?

ARGX-111 has been studied in a single completed clinical trial, identified as NCT02055066. This was a Phase 1b study titled 'A Phase 1b Study of ARGX-111 in Patients With Advanced Cancer,' which enrolled 24 participants in Belgium. The trial included adults aged 18 years and older.

Is ARGX-111 FDA approved?

ARGX-111 is not FDA approved. It is an investigational drug that has completed a Phase 1b clinical trial in advanced cancer patients. The drug remains in clinical development and has not yet been authorized for commercial use by regulatory authorities.