A Phase 1b Study of ARGX-111 in Patients With Advanced Cancer.

NCT02055066 | Completed Phase 1 DMC

• 1 other identifier: ARGX-111-1301
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 2

Brief Summary

This a first-in-human study of an antibody blocking the function of the oncogene c-met in patients with cancer.

Conditions

Cancer

Keywords

cancer; c-MET

Outcome Measures

Primary Outcomes (1)

• Dose-limiting toxicity

  Number of patients with grade 3 or 4 toxicity

  1 month

Secondary Outcomes (3)

• 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

Study Arms (4)

Arm 1

EXPERIMENTAL

ARGX-111 0.3 mg/kg

Drug: ARGX-111

Arm 2

EXPERIMENTAL

ARGX-111 1.0 mg/kg

Drug: ARGX-111

Arm 3

EXPERIMENTAL

ARGX-111 3.0 mg/kg

Drug: ARGX-111

Arm 4

EXPERIMENTAL

ARGX-111 10 mg/kg

Drug: ARGX-111

Interventions

ARGX-111 DRUG

Arm 1; Arm 2; Arm 3; Arm 4

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Written informed consent.
• Age ≥ 18 years.
• Performance status of 0 or 1.
• Histological diagnosis of malignancy.
• Cancer relapsing after, or refractory to standard therapy.
• Malignancy over-expressing the c Met protein.
• Presence of circulating tumor cells (CTCs).
• At least one tumor lesion \> 2 cm on PET/CT.
• Serum albumin \> 35 g/L.
• Absolute neutrophil count (ANC) \> 1.0 x 109/L.
• Hemoglobin \> 90 g/L (0.9 g/dL).
• Platelet count ≥ 75 x 109/L.
• Coagulation parameters ≤ 1.5 x ULN.
• Total bilirubin ≤ 1.5 x upper limit of normal (ULN).
• Creatine Phosphokinase (CPK) ≤ 2.5 x ULN.

You may not qualify if:

• History or clinical evidence of neoplastic central nervous system (CNS) involvement.
• Major surgery within 4 weeks of ARGX 111 first dose administration.
• Systemic glucocorticoid administration at doses greater than physiological replacement (prednisone 20 mg equivalent) within 3 weeks of ARGX 111 first dose administration.
• Cytotoxic chemotherapy within 3 weeks of ARGX 111 first dose administration.
• Radiation therapy with curative intent within 3 weeks of ARGX 111 first dose administration.
• Biological therapy (monoclonal antibodies) within 4 weeks of ARGX 111 first dose administration.
• Biological therapy (other than monoclonal antibodies) within 5 half-lives of ARGX 111 first dose administration.
• Unresolved Grade 3 or 4 toxicity from prior therapy, including experimental therapy.
• History of recurrent Grade 3 or 4 toxicity from anti c Met therapy.
• Uncontrolled diabetes, defined as fasting glycemia \> 150 mg/dl).
• Active, untreated viral, bacterial, or systemic fungal infection.
• Any clinical finding, including psychiatric and behavioral problems, which, in the opinion of the Investigator, precludes the patient from safely participating in the study.
• Childbearing potential (unless using an adequate measure of contraception).
• Pregnancy or lactation.
• History of severe (Grade 3 or 4) hypersensitivity to recombinant proteins.

Sponsors & Collaborators

• argenx: lead

Study Sites (2)

Universitair Zieckenhuis Antwerpen

Antwerp, Belgium

Location

Institut Jules Bordet

Brussels, Belgium

Location

MeSH Terms

Conditions

Neoplasms

Interventions

ARGX-111

Study Officials

• Ahmad Awada, MD

  Jules Bordet Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 31, 2014
• First Posted: February 4, 2014
• Study Start: January 1, 2014
• Primary Completion: March 1, 2017
• Study Completion: March 1, 2017
• Last Updated: April 21, 2017

Record last verified: 2017-04

Locations

BE (2)