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

May 16, 2022 updated by: Providence Health & Services

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Oregon
      • Portland, Oregon, United States, 97213
        • Providence Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

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

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: KLH + anti-OX40
Day 1: KLH + anti-OX40; Day 3: anti-OX40; Day 4: anti-OX40; Day 29: Tetanus vaccine
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
Other Names:
  • Tetanus Toxoid, Tetanus Toxoid Adsorbed
Biological: KLH Day 1
1 mg KLH in 1 cc diluent subcutaneously on Day 1.
Other Names:
  • Immucothel.
EXPERIMENTAL: Tetanus vaccine + anti-OX40
Day 1: Tetanus vaccine + anti-OX40; Day 3: anti-OX40; Day 5: anti-OX40; Day 29: KLH
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 1
Tetanus toxoid vaccine 0.5ml (5 LF/ml tetanus toxoid)on Day 1.
Other Names:
  • Tetansu Toxoid, Tetanus Toxoid Adsorbed.
Biological: KLH Day 29
1 mg KLC in 1 cc diluent by subcutaneous injection on Day 29.
Other Names:
  • Immucothel.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Dose limiting toxicity
Time Frame: 28 Days
A dose limiting toxicity is defined as any grade >=3 hematologic (except lymphopenia) or non-hematologic toxicity (except hypothyroidism or vitiligo) that, in the opinion of the investigator is considered at lease possibly related to the study treatment. If DLT is observed in greater than two patient in any cohort, then the previous cohort will be the maximal tolerated dose.
28 Days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Immune Response
Time Frame: Pre-study, Days 5, 8, 15, 29, 36, 43, and 57.
Blood tests and leukapheresis product will be collected to determine the response to three types of reporter antigens: (1) new antigen (keyhole limpet hemocyanin (KLH)), (2) recall protein antigen (tetanus), and (3) viral antigen (cytomegalovirus (CMV)). Changes in the number of antigens will be used to determine immune response.
Pre-study, Days 5, 8, 15, 29, 36, 43, and 57.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Providence Health & Services

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

November 1, 2003

Primary Completion (ACTUAL)

May 1, 2009

Study Completion (ACTUAL)

April 1, 2017

Study Registration Dates

First Submitted

July 17, 2012

First Submitted That Met QC Criteria

July 18, 2012

First Posted (ESTIMATE)

July 19, 2012

Study Record Updates

Last Update Posted (ACTUAL)

May 17, 2022

Last Update Submitted That Met QC Criteria

May 16, 2022

Last Verified

May 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 03-066A

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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