Melanoma Clinical Trial
Official title:
A Phase 1 Study of the Safety and Efficacy of GC1008: A Human Anti Transforming Growth Factor-beta (TGFβ) Monoclonal Antibody in Patients With Advanced Renal Cell Carcinoma or Malignant Melanoma
The purpose of this study is to determine the safety, tolerability, pharmacokinetics and pharmacodynamics of GC1008, a human anti-transforming growth factor-beta (TGFβ) monoclonal antibody in previously treated patients with locally advanced or metastatic renal cell carcinoma or malignant melanoma.
Transforming growth factor-beta (TGFβ) is a cytokine which is often over-expressed and
over-produced by malignancies and has been implicated as an important factor in promoting
the growth, progression, and metastatic potential of advanced cancers. In preclinical
studies, TGFβ can act to promote tumor cell migration/invasiveness, influence tumor stroma
(by increasing extracellular matrix production, cytokine secretion, and angiogenesis), and
suppress anti-tumor immunity. The purpose of this study is to investigate the clinical use
of GC1008, a human monoclonal antibody capable of binding and neutralizing all isoforms of
TGFβ.
This is a Phase 1 multi-center, open-label, dose-escalation study designed to characterize
the safety, tolerability, pharmacokinetic, pharmacodynamic, and potential anti-tumor
activity of GC1008, in patients with histologically confirmed, locally advanced and
surgically inoperable or metastatic renal cell carcinoma (RCC) or malignant melanoma.
Patients with RCC must have failed at least 1 prior therapy and patients with renal cell
carcinoma must have failed either sorafenib or sunitinib. Other qualifying prior therapies
includes any medical, surgical, radiation or investigational approaches used for potential
therapeutic benefit (but not for diagnostic purposes) in patients with advanced disease.
Patients may receive up to 4 intravenous infusions of GC1008, and patients with stable
disease, with an objective tumor response or with clinical benefit may be eligible to
receive extended therapy. For part 2 of the study, only patients with malignant melanoma
will be enrolled.
;
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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