Completed

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

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What is being tested

Cohort 1 anti-OX40

+ Cohort 2 anti-OX40

+ Cohort 3 anti-OX40

DrugBiological
Who is being recruted

Carcinoma+9

+ Hemic and Lymphatic Diseases

+ Immune System Diseases

Over 18 Years
+17 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 1
Interventional
Study Start: November 2003
See protocol details

Summary

Principal SponsorProvidence Health & Services
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: November 1, 2003

Actual date on which the first participant was enrolled.

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.

Official TitlePhase 1 Trial of a Monoclonal Antibody to OX40 in Patients With Advanced Cancer.
NCT01644968
Principal SponsorProvidence Health & Services
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

30 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

CarcinomaHemic and Lymphatic DiseasesImmune System DiseasesImmunoproliferative DisordersLymphatic DiseasesLymphomaLymphoproliferative DisordersNeoplasmsNeoplasms by Histologic TypeNeoplasms, Glandular and EpithelialSarcomaNeoplasms, Connective and Soft Tissue

Criteria

5 inclusion criteria required to participate
ECOG performance status 0, 1, 2
No active bleeding
Patients with uncurable metastatic carcinoma, lymphoma, or sarcoma.
No clinical coagulopathy
Show More Criteria
12 exclusion criteria prevent from participating
Active residual toxicity from prior therapies
Active Infection
HIV positive
Hepatitis B or C positive
Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

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

Group II

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

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

Providence Cancer Center

Portland, United StatesOpen Providence Cancer Center in Google Maps
CompletedOne Study Center