A Phase I Study of ARGX-110 in Patients With Advanced Malignancies Expressing CD70
- Age ≥18 years.
- Written informed consent prior to any study-related procedure, willing and able to
comply with protocol-specified procedures and scheduled evaluations.
- Histological diagnosis of CD70 antigen positive malignancies refractory to, or
relapsing after standard therapy.
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.
- Adequate haematological, hepatic, and renal function (absolute neutrophil count (ANC)
> 1.0 x 109/L; haemoglobin > 90 g/L; platelet count ≥ 75 x 109/L; total bilirubin ≤
1.5 x the upper limit of normal [ULN]; alanine transaminase [ALT] ≤ 3 x ULN or ≤ 5 x
ULN for patients with liver metastases; serum creatinine ≤ 1.5 x the ULN).
- Prior allogeneic bone marrow transplantation.
- History or clinical evidence of neoplastic central nervous system (CNS) involvement.
- History of another primary malignancy that has not been in remission for at least 1
- Systemic glucocorticoid administration at doses greater than physiological
replacement within 4 weeks of ARGX-110 first dose administration.
- Major surgery within 4 weeks of ARGX-110 first dose administration.
- Prior chemotherapy, biological therapy, radiation therapy with curative intent, or
any experimental therapy within 4 weeks of ARGX-110 first dose administration.
- Unresolved grade 3 or 4 toxicity from prior therapy, including experimental therapy.
- Active, untreated viral, bacterial, or systemic fungal infection.
- History of human immunodeficiency virus (HIV) infection, persistent hepatitis B virus
surface antigen (HBsAg), or hepatitis C virus (HCV) infection.
- Any clinical finding, including psychiatric and behavioral problems, which, in the
opinion of the Investigator, precludes the patient from safely participating in the
- Childbearing potential unless using an adequate measure of contraception.
- Pregnancy or lactation.
- History of hypersensitivity to recombinant proteins.