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

argenx

Status and phase: Completed; Phase 1

Conditions: Cancer

Treatments: Drug: ARGX-111

Study type: Interventional

Funder types: Industry

Identifiers

NCT02055066

ARGX-111-1301

Details and patient eligibility

About

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

Full description

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.

Enrollment: 24 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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).
8. At least one tumor lesion > 2 cm on PET/CT.
9. Serum albumin > 35 g/L.
10. Absolute neutrophil count (ANC) > 1.0 x 109/L.
11. Hemoglobin > 90 g/L (0.9 g/dL).
12. Platelet count ≥ 75 x 109/L.
13. Coagulation parameters ≤ 1.5 x ULN.
14. Total bilirubin ≤ 1.5 x upper limit of normal (ULN).
15. Creatine Phosphokinase (CPK) ≤ 2.5 x ULN.
16. Serum creatinine ≤ 1.5 x ULN.
17. Ability to comply with protocol-specified procedures/evaluations and scheduled visits.

Exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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24 participants in 4 patient groups

Arm 1

Experimental group

Description:

ARGX-111 0.3 mg/kg

Treatment:

Drug: ARGX-111

Arm 2

Experimental group

Description:

ARGX-111 1.0 mg/kg

Treatment:

Drug: ARGX-111

Arm 3

Experimental group

Description:

ARGX-111 3.0 mg/kg

Treatment:

Drug: ARGX-111

Arm 4

Experimental group

Description:

ARGX-111 10 mg/kg

Treatment:

Drug: ARGX-111