NCT01644968

Phase 1 Study of Anti-OX40 in Patients With Advanced Cancer

Phase 1 Trial of a Monoclonal Antibody to OX40 in Patients With Advanced Cancer.

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Providence Health & Services · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study is designed to determine the safety and highest tolerated dose of anti-OX40 in patients with advanced cancer.

Detailed description

This study will evaluate the safety and determine the maximal tolerated dose of anti-OX40; evaluated the immune response to the study treatment; measure the pharmacokinetics of anti-OX40; monitor tumor regression, and identify the most biologically active dose of anti-OX40 to induce antigen-specific responses to a variety of immunogens.

Conditions

• Advanced Cancer

Interventions

Type	Name	Description
DRUG	Cohort 1 anti-OX40	0.1 mg/kg anti-OX40 on days 1, 3, and 5
DRUG	Cohort 2 anti-OX40	.4 mg/kg anti-OX40 on days 1, 3, and 5
DRUG	Cohort 3 anti-OX40	2.0 mg/kg anti-OX40 on days 1, 3, and 5
BIOLOGICAL	Tetanus Day 29	Tetanus toxoid vaccine 0.5ml (5 LF/ml tetanus toxoid)on Day 29
BIOLOGICAL	Tetanus Day 1	Tetanus toxoid vaccine 0.5ml (5 LF/ml tetanus toxoid)on Day 1.
BIOLOGICAL	KLH Day 1	1 mg KLH in 1 cc diluent subcutaneously on Day 1.
BIOLOGICAL	KLH Day 29	1 mg KLC in 1 cc diluent by subcutaneous injection on Day 29.

Timeline

• Start date: 2003-11-01
• Primary completion: 2009-05-01
• Completion: 2017-04-01
• First posted: 2012-07-19
• Last updated: 2022-05-17

Locations

1 site across 1 country: United States