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Advanced CancerPhase 1NCT01644968

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

A Phase 1 study testing Cohort 1 anti-OX40, Cohort 2 anti-OX40 and Cohort 3 anti-OX40 in people with Advanced Cancer, run by Providence Health & Services at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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

Who is it for?
Ages 18 years and older
Conditions the study is for
Advanced Cancer
What is being tested?
Cohort 1 anti-OX40, Cohort 2 anti-OX40 and Cohort 3 anti-OX40
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteUnited States
Study dates
Nov 2003to Apr 2017
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • Active residual toxicity from prior therapies
  • Active Infection
  • HIV positive
  • Hepatitis B or C positive
  • Pregnant or nursing women
  • Requirement for oral steroids
Show all 12Show fewer
  • 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 locations and contacts

1 site in 1 country.

United States1 site

  • Providence Cancer Center

    Portland, Oregon, 97213

Other trials in United States

About this study

Official title: 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.

Read the 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
Being tested
Cohort 1 anti-OX40, Cohort 2 anti-OX40, Cohort 3 anti-OX40, Tetanus Day 29, Tetanus Day 1
Keywords
metastatic carcinoma, lymphoma, sarcoma, anti-OX40
Medical subject headings
Carcinoma, Lymphoma, Sarcoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Cohort 1 anti-OX40Drug

    0.1 mg/kg anti-OX40 on days 1, 3, and 5

  • Cohort 2 anti-OX40Drug

    .4 mg/kg anti-OX40 on days 1, 3, and 5

  • Cohort 3 anti-OX40Drug

    2.0 mg/kg anti-OX40 on days 1, 3, and 5

  • Tetanus Day 29Biological

    Also called Tetanus Toxoid, Tetanus Toxoid Adsorbed

    Tetanus toxoid vaccine 0.5ml (5 LF/ml tetanus toxoid)on Day 29

  • Tetanus Day 1Biological

    Also called Tetansu Toxoid, Tetanus Toxoid Adsorbed.

    Tetanus toxoid vaccine 0.5ml (5 LF/ml tetanus toxoid)on Day 1.

  • KLH Day 1Biological

    Also called Immucothel.

    1 mg KLH in 1 cc diluent subcutaneously on Day 1.

  • KLH Day 29Biological

    Also called Immucothel.

    1 mg KLC in 1 cc diluent by subcutaneous injection on Day 29.

Study groups in NCT01644968
Study groupRoleWhat they receive
KLH + anti-OX40ExperimentalDay 1: KLH + anti-OX40; Day 3: anti-OX40; Day 4: anti-OX40; Day 29: Tetanus vaccine
Receives: Drug: Cohort 1 anti-OX40; Drug: Cohort 2 anti-OX40; Drug: Cohort 3 anti-OX40; Biological: Tetanus Day 29; Biological: KLH Day 1
Tetanus vaccine + anti-OX40ExperimentalDay 1: Tetanus vaccine + anti-OX40; Day 3: anti-OX40; Day 5: anti-OX40; Day 29: KLH
Receives: Drug: Cohort 1 anti-OX40; Drug: Cohort 2 anti-OX40; Drug: Cohort 3 anti-OX40; Biological: Tetanus Day 1; Biological: KLH Day 29

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Dose limiting toxicity

    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.

    Measured: 28 Days

Secondary outcomes (1)

  1. Immune Response

    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.

    Measured: Pre-study, Days 5, 8, 15, 29, 36, 43, and 57.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Jul 2012 (estimated)
  2. Study startNov 2003
  3. Primary completionMay 2009
  4. Study completionApr 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
30 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01644968
Sponsor's protocol ID
03-066A
Status last verified
May 2022
First submitted
17 Jul 2012
Last updated
17 May 2022
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Publications

  • Curti BD, Kovacsovics-Bankowski M, Morris N, Walker E, Chisholm L, Floyd K, Walker J, Gonzalez I, Meeuwsen T, Fox BA, Moudgil T, Miller W, Haley D, Coffey T, Fisher B, Delanty-Miller L, Rymarchyk N, Kelly T, Crocenzi T, Bernstein E, Sanborn R, Urba WJ, Weinberg AD. OX40 is a potent immune-stimulating target in late-stage cancer patients. Cancer Res. 2013 Dec 15;73(24):7189-7198. doi: 10.1158/0008-5472.CAN-12-4174. Epub 2013 Oct 31.

    PubMed 24177180

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Cohort 1 anti-OX40, Cohort 2 anti-OX40 and Cohort 3 anti-OX40 in people with Advanced Cancer, run by Providence Health & Services at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 May 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Dose limiting toxicity (time frame: 28 Days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01644968, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 May 2022.

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