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

Cancer Clinical Trial

Official title:

A Phase 1b Study of ARGX-111 in Patients With Advanced Cancer Over-expressing the c-Met Protein.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02055066
• Other study ID #: ARGX-111-1301
• Status: Completed
• Phase: Phase 1
• First received: January 31, 2014
• Last updated: April 20, 2017
• Start date: January 2014
• Est. completion date: March 2017

Study information

• Verified date: April 2017
• Source: arGEN-X BVBA
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: March 2017
• Est. primary completion date: March 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cancer

Intervention

Drug:
• ARGX-111

Locations

Country	Name	City	State
Belgium	Universitair Zieckenhuis Antwerpen	Antwerp
Belgium	Institut Jules Bordet	Brussels

Sponsors (1)

Lead Sponsor	Collaborator
arGEN-X BVBA

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Dose-limiting toxicity	Number of patients with grade 3 or 4 toxicity	1 month
Secondary	Pharmacokinetic profiles (Cmax , Ctrough, AUC, Vd , clearance, and half-life)	Measurement of drug concentration in the blood	C1 D1 (pre, 0h, 2h, 6h, 12h, 24h), C1D8, C1D15; Cycle =2 o D1 pre-/post-dose
Secondary	Biomarkers (Hepatocyte growth factor; ADCC)	measurements of cytokine changes in blood as a result of drug administration	Base-line and pre-dose at each cycle for an average of 4 months
Secondary	Incidence of adverse events per dose level		for an average of 4 months