Anti-OX40 Antibody (MEDI6469) in Patients With Metastatic Colorectal Cancer

• Status: Unknown status
• Trial end date: 2021-09-01
• Target enrollment: 0
• Participant gender: All

Summary

This study will test the ability of an immune modulator, anti-OX40 (MEDI6469) to alter the immune cell environment within colorectal cancer metastases. The drug will be administered to patients before surgical treatment.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Providence Health & Services
• Collaborator: MedImmune LLC
• Treatments: Antibodies; Immunoglobulins

Criteria

Inclusion Criteria:

• Patients who will undergo staged liver resections are included in this study. In these cases, preoperative MEDI6469 will be given prior to the initial procedure.

• Patients with small <3 cm tumors located >2 cm away from central bile ducts will be considered for either radiofrequency ablation or resection, the choice of which will be determined at the time of surgery.

• Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1

• Laboratory values during preoperative assessment within the protocol specified range

• Ability to give informed consent and comply with the protocol. Patients with a history of psychiatric illness must be judged able to understand the investigational nature of the study and the risks associated with the therapy.

• No active gastrointestinal bleeding.

• No clinical or laboratory coagulopathy

• Anticipated lifespan greater than 12 weeks

Exclusion Criteria:

• Metastatic disease outside of the liver that is not considered surgically resectable or curable.

• Active infection.

• Active autoimmune disease including patients with Inflammatory Bowel Disease as determined by an autoimmune questionnaire.

• Previous treatment with mouse monoclonal antibodies.

• Need for chronic maintenance oral steroids.

• Any medical or psychiatric condition that in the opinion of the PI would preclude compliance with study procedures.

• Enrollment in a clinical trial in which a different investigational agent is administered within 4 weeks prior to the first dose of MEDI6469.