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.
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
- Type of treatment
- Vaccines, Injection or infusion
- 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.
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 group | Role | What they receive |
|---|---|---|
| KLH + anti-OX40 | Experimental | Day 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-OX40 | Experimental | Day 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.
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)
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.
- First posted19 Jul 2012 (estimated)
- Study startNov 2003
- Primary completionMay 2009
- Study completionApr 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Advanced CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Providence Health & Services
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Brendan Curti, MD, Principal investigator, Providence Health & Services
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
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1 Trial of a Monoclonal Antibody to OX40 in Patients With Advanced Cancer.
- ClinicalTrials.gov ID
- NCT01644968
- Acronym / sponsor ID
- 03-066A
- Conditions
- Advanced Cancer
- Keywords
- metastatic carcinoma, lymphoma, sarcoma, anti-OX40
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Providence Health & ServicesUniversity, hospital or other
- Study start
- Nov 2003 (actual)
- Primary completion
- May 2009 (actual)
- Study completion
- Apr 2017 (actual)
- First posted
- 19 Jul 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is designed to determine the safety and highest tolerated dose of anti-OX40 in patients with advanced cancer.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| KLH + anti-OX40 | Experimental | Drug: Cohort 1 anti-OX40, Drug: Cohort 2 anti-OX40, Drug: Cohort 3 anti-OX40, Biological: Tetanus Day 29, Biological: KLH Day 1Day 1: KLH + anti-OX40; Day 3: anti-OX40; Day 4: anti-OX40; Day 29: Tetanus vaccine |
| Tetanus vaccine + anti-OX40 | Experimental | Drug: Cohort 1 anti-OX40, Drug: Cohort 2 anti-OX40, Drug: Cohort 3 anti-OX40, Biological: Tetanus Day 1, Biological: KLH Day 29Day 1: Tetanus vaccine + anti-OX40; Day 3: anti-OX40; Day 5: anti-OX40; Day 29: KLH |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (12 listed)
- Active residual toxicity from prior therapies
- Active Infection
- HIV positive
- Hepatitis B or C positive
- Pregnant or nursing women
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cohort 1 anti-OX400.1 mg/kg anti-OX40 on days 1, 3, and 5 | Drug | KLH + anti-OX40, Tetanus vaccine + anti-OX40 |
| Cohort 2 anti-OX40.4 mg/kg anti-OX40 on days 1, 3, and 5 | Drug | KLH + anti-OX40, Tetanus vaccine + anti-OX40 |
| Cohort 3 anti-OX402.0 mg/kg anti-OX40 on days 1, 3, and 5 | Drug | KLH + anti-OX40, Tetanus vaccine + anti-OX40 |
| Tetanus Day 29Also: Tetanus Toxoid, Tetanus Toxoid AdsorbedTetanus toxoid vaccine 0.5ml (5 LF/ml tetanus toxoid)on Day 29 | Biological | KLH + anti-OX40 |
| Tetanus Day 1Also: Tetansu Toxoid, Tetanus Toxoid Adsorbed.Tetanus toxoid vaccine 0.5ml (5 LF/ml tetanus toxoid)on Day 1. | Biological | Tetanus vaccine + anti-OX40 |
| KLH Day 1Also: Immucothel.1 mg KLH in 1 cc diluent subcutaneously on Day 1. | Biological | KLH + anti-OX40 |
| KLH Day 29Also: Immucothel.1 mg KLC in 1 cc diluent by subcutaneous injection on Day 29. | Biological | Tetanus vaccine + anti-OX40 |
Primary outcome
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.
1 secondary outcome
Immune Response
Time frame: Pre-study, Days 5, 8, 15, 29, 36, 43, and 57.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2022.
- Derived from this study: PubMed 24177180Curti 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.
- Individual participant dataSharing planned: No
Related trials for Advanced Cancer
Enrolling by invitationPhase 2
A Single-Arm Study of Nimotuzumab Combined With NALIRIFOX as First-Line Treatment for Pancreatic Cancer
Pancreatic Cancer Metastatic
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
Active, not recruitingPhase 3
A Study of Belzutifan (MK-6482) in Combination With Lenvatinib Versus Cabozantinib for Treatment of Renal Cell Carcinoma (MK-6482-011)
Carcinoma, Renal Cell
RecruitingPhase 3
A Study Evaluating Sotorasib Platinum Doublet Combination Versus Pembrolizumab Platinum Doublet Combination as a Front-Line Therapy in Participants With Stage IV or Advanced Stage IIIB/C Nonsquamous Non-Small Cell Lung Cancers (CodeBreaK 202)
Non-Small Cell Lung Cancer (NSCLC)
Active, not recruitingPhase 1
A Study to Assess Safety, Tolerability, and Pharmacokinetics of ABSK043 in Patients With Advanced Solid Tumor
Neoplasms
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Brendan Curti, MD principal investigator
Providence Health & Services
1 site in 1 country: see every site and its status.
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.