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A Phase I Study of ARGX-110 in Patients With Advanced Malignancies Expressing CD70

Phase 1
18 Years
Open (Enrolling)
Advanced Cancers

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Trial Information

A Phase I Study of ARGX-110 in Patients With Advanced Malignancies Expressing CD70

Inclusion Criteria:

- 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).

Exclusion Criteria:

- 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.

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Number of patients with Dose-Limiting Toxicity

Outcome Description:

DLT defined as drug-related Grade 3 or 4 Adverse Events (CTCAE criteria version 4)

Outcome Time Frame:

1 year

Safety Issue:



Belgium: Federal Agency for Medicinal Products and Health Products

Study ID:




Start Date:

February 2013

Completion Date:

December 2014

Related Keywords:

  • Advanced Cancers
  • malignancy
  • Neoplasms