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

This Phase 1b trial will characterize the safety profile of ARGX 111 and will thus provide the first elements towards establishing an accurate risk-benefit assessment for ARGX 111 in cancer patients.

Inclusion criteria

• 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.
• Serum creatinine ≤ 1.5 x ULN.
• Ability to comply with protocol-specified procedures/evaluations and scheduled visits.

Exclusion criteria

• 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.