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

Providence Health & Services

Status and phase: Completed; Phase 1

Conditions: Advanced Cancer

Treatments: Drug: Cohort 3 anti-OX40; Drug: Cohort 1 anti-OX40; Biological: Tetanus Day 29; Biological: KLH Day 29; Biological: Tetanus Day 1; Drug: Cohort 2 anti-OX40; Biological: KLH Day 1

Study type: Interventional

Funder types: Other

Identifiers

NCT01644968

03-066A

Details and patient eligibility

About

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

Full 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.

Enrollment: 30 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients with uncurable metastatic carcinoma, lymphoma, or sarcoma.
• ECOG performance status 0, 1, 2
• No active bleeding
• No clinical coagulopathy
• Anticipated lifespan greater than 12 weeks

Exclusion criteria

• Active residual toxicity from prior therapies
• Active Infection
• HIV positive
• Hepatitis B or C positive
• Pregnant or nursing women
• Requirement for oral steroids
• Brain metastases
• Presence or history of autoimmune disease
• Shellfish or tetanus allergy
• Splenomegaly
• Lymph nodes greater than 10 cm in maximal diameter
• Uncontrolled angina or class II or IV heart failure

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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30 participants in 2 patient groups

KLH + anti-OX40

Experimental group

Description:

Day 1: KLH + anti-OX40; Day 3: anti-OX40; Day 4: anti-OX40; Day 29: Tetanus vaccine

Treatment:

Biological: KLH Day 1

Drug: Cohort 2 anti-OX40

Biological: Tetanus Day 29

Drug: Cohort 3 anti-OX40

Drug: Cohort 1 anti-OX40

Tetanus vaccine + anti-OX40

Experimental group

Description:

Day 1: Tetanus vaccine + anti-OX40; Day 3: anti-OX40; Day 5: anti-OX40; Day 29: KLH

Treatment:

Drug: Cohort 2 anti-OX40

Biological: KLH Day 29

Biological: Tetanus Day 1

Drug: Cohort 3 anti-OX40

Drug: Cohort 1 anti-OX40