NCT00661414

Safety Study of ASONEP (Sonepcizumab/LT1009) to Treat Advanced Solid Tumors

A Multi-Center, Open-Label, Single-Arm, Phase 1, Dose Escalation Study of ASONEP (Sonepcizumab/LT1009) Administered as a Single Agent Weekly to Subjects With Refractory Advanced Solid Tumors

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 37 (actual)
• Sponsor: Lpath, Inc. · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine the safety, tolerability and highest dose of ASONEP that can safely be administered to patients with cancer who are no longer being helped by standard treatments.

Detailed description

ASONEP™ (sonepcizumab/LT1009) is a humanized monoclonal antibody that possesses anti-angiogenic and anti-tumor activity in animal models of human cancer. ASONEP™ binds sphingosine 1-phosphate (S1P), a bioactive lipid signaling molecule that possesses potent pro-growth effects. Preclinical studies with ASONEP™ (sonepcizumab/LT1009) and LT1002 (murine homolog of LT1009), demonstrate the potential of an anti-S1P treatment to reduce tumor volumes and metastatic potential, likely as a result of inhibiting new blood vessel formation needed to support tumor growth. Lpath is developing ASONEP™ (sonepcizumab/LT1009) for the following therapeutic indication: ASONEP™ \[parenteral sonepcizumab (LT1009) for the treatment of cancer\] is indicated for use in combination with TBD cytotoxic agents and other anti-angiogenic agents as second-line therapy to treat patients with an unresectable, locally advanced, recurrent or metastatic TBD cancer.

Conditions

• Solid Tumors

Interventions

Type	Name	Description
BIOLOGICAL	ASONEP (sonepcizumab/LT1009)	ASONEP \[sonepcizumab/LT1009\] is supplied as a colorless,particulate-free, pH 6.5, sterile solution containing approximately 10 mg/mL or 20 mg/mL of drug. The candidate drug is intended for single intravenous (iv) use administered over 90 minutes on a weekly basis.

Timeline

• Start date: 2008-04-01
• Primary completion: 2011-12-01
• Completion: 2011-12-01
• First posted: 2008-04-18
• Last updated: 2012-01-31

Locations

3 sites across 1 country: United States