Study of AS1409 in Patients With Either Metastatic Renal Cell Carcinoma or Metastatic Malignant Melanoma

NCT ID: NCT00625768

Last Updated: 2009-08-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 13 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-01-31
• Study Completion Date: 2009-04-30

Brief Summary

To determine the tolerability, safety, end-organ toxicity and maximum tolerated dose of AS1409 in single and repeated doses.

Detailed Description

• To determine the tolerability, safety, end-organ toxicity and maximum tolerated dose (MTD) of AS1409 in single and repeated doses.
• To determine biological responses to AS1409, including interferon-γ and IP-10 circulating concentrations.
• To determine preliminary pharmacokinetics of AS1409.
• To determine the immunogenicity of AS1409
• To explore the anti-tumour activity of AS1409.

Conditions

Metastatic Renal Cell Carcinoma; Metastatic Malignant Melanoma

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

AS1409

Study drug

Intervention Type: DRUG

Other Intervention Names

huBC1-huIL-12

Eligibility Criteria

Inclusion Criteria

• Be 18 years or older at the time of giving informed consent.
• Histologically confirmed diagnosis of renal cell carcinoma or malignant melanoma.
• If renal cell carcinoma, of clear cell or chromophilic/papillary type, with metastases at any site (but excluding patients with single bony lesion only).
• If malignant melanoma, unresectable Stage III disease or Stage IV disease, with metastases at any site (but excluding patients with single bony lesion only)
• Patients with clinically stable CNS metastases may enter who have been treated with surgery or radiation and who do not require steroid therapy.
• ECOG performance status 0-2.
• Patients who have received prior systemic treatment for their malignancy with chemotherapeutic or biological therapies may enter, provided treatment was completed within 4 weeks of study entry.
• Patients who have received prior experimental therapy may enter, provided treatment was completed within 12 weeks of study entry.
• Have adequate bone marrow function as evidenced by neutrophils >1.5 x109/L and platelets >100 x109/L.
• Have adequate liver and kidney function, as shown by serum bilirubin ≤1.5x upper limit of normal for the laboratory; ALT and AST both ≤2x upper limit of normal; and creatinine ≤1.5x upper limit of normal.
• Have either evaluable or measurable disease (patients entering an ascending dosage cohort) or measurable disease (patients entering the study after MTD is defined).
• Patients who have failed and or are ineligible for standard first line therapy (in accordance with individual institutional practice)

Exclusion Criteria

Patients with any of the following will be excluded from the study:

• Patients at poor medical risk because of non-malignant systemic disease or active infection.
• History of clinically significant autoimmune or predominantly Th1-driven clinical disorders (such as rheumatoid arthritis, psoriasis, chronic inflammatory bowel disease, for example), with the exception of autoimmune endocrinopathies now treated with replacement therapy.
• Diabetic retinopathy.
• Substantive surgery within 4 weeks prior to study entry, or expectation of surgery during the study period.
• Malignancy other than renal cell carcinoma or malignant melanoma within 5 years of study entry, except for non-melanoma skin cancer and cervical intraepithelial neoplasia treated definitively or other cancer from which the patient has been disease-free for 5 years.
• Concurrent treatment with systemic steroids or with other immunosuppressive therapies.
• If female, pregnant or breastfeeding;
• Women of child bearing potential or sexually active males, unless (1) the patient (if female, or the patient's partner, if male) is surgically sterile or (2) using adequate contraception (defined as either IUD, oral or depot contraceptive, or barrier plus spermicide) while receiving study treatment and for at least 6 months after termination of treatment. Women must be post-menopausal for at least 2 years to be considered of non-childbearing potential
• Any concurrent medical or psychological condition that would limit the ability of the patient to provide informed consent or to comply with the obligations of the study.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Antisoma Research

INDUSTRY

Sponsor Role: lead

Responsible Party

Antisoma Research

Principal Investigators

James Spicer, MD

Role: PRINCIPAL_INVESTIGATOR

Kings College School of Medicine

Locations

Auckland Medical School

Auckland, , New Zealand

Waikato DHB

Hamilton, , New Zealand

Guys Hospital

London, , United Kingdom

Charing Cross Hospital

London, , United Kingdom

Countries

New Zealand; United Kingdom

References

Rudman SM, Jameson MB, McKeage MJ, Savage P, Jodrell DI, Harries M, Acton G, Erlandsson F, Spicer JF. A phase 1 study of AS1409, a novel antibody-cytokine fusion protein, in patients with malignant melanoma or renal cell carcinoma. Clin Cancer Res. 2011 Apr 1;17(7):1998-2005. doi: 10.1158/1078-0432.CCR-10-2490. Epub 2011 Mar 29.

Reference Type: DERIVED

PMID: 21447719 (View on PubMed)

Other Identifiers

AS1409-101

Identifier Type: -

Identifier Source: org_study_id