Solid TumorsPhase 1NCT01556789
Phase 1 Study of ONT-10 in Patients With Solid Tumors
A Phase 1 study testing ONT-10 in people with Solid Tumors, run by Cascadian Therapeutics Inc. at 3 sites in United States.
Trial summary
Open label, two part, Phase 1 dose escalation study to evaluate the safety and immunogenicity of repeat dose vaccination with ONT-10 in patients with previously treated Stage 3 or 4 solid tumors. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Solid Tumors
- What is being tested?
- ONT-10
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 85 participants
- Where
- 3 sitesUnited States
- Study dates
- Mar 2013to Sep 2015
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Be 18 to 70 years of age at time of consent
- Life expectancy of at least 6 months, in the opinion of the investigator
- A) Have histologically confirmed breast, non-small cell lung, ovarian, colorectal, gastric, prostate, pancreatic, or renal cell cancer, or other tumor type as approved by the study medical monitor (Part 1) B) Have histologically confirmed breast or ovarian carcinoma (Part 2)
- Have evidence of persistent, recurrent, or progressive disease after at least one course of systemic therapy for locally advanced or metastatic disease, including chemotherapy, targeted therapy, or immunotherapy
- Clinical stage 3 or 4 disease
- ECOG 0 or 1
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- Adequate baseline hematological parameters as defined by white blood cell count (WBC) ≥ 3.5 x 103/uL, lymphocyte count ≥ 1.0 x 103/uL, platelet count ≥ 100 x 103/uL, and hemoglobin ≥ 9 g/dL
- Have renal and hepatic function laboratory test results not to exceed 1.5 X upper limit of normal (ULN)
- If female of child bearing potential, have a negative pregnancy test at screening
- If fertile male or female of child-bearing potential, agree to consistently use a highly effective method of birth control (including birth control pills, barrier device, or intrauterine device) from the time of consent through 3 months following the last dose of study drug.
- Be able and willing to sign informed consent document that has been approved by an institutional review board or independent ethics committee (IRB/IEC)
Who cannot join
- Has medical, social, or psychosocial factors that, in the opinion of the investigator, could impact safety or compliance with study procedures
- Is pregnant, breastfeeding, or planning a pregnancy
- Has received treatment with any systemic chemotherapy, radiation, or experimental agent within 4 weeks of study drug dosing
- Has untreated or uncontrolled central nervous system (CNS) metastases, including patients who require glucocorticoid therapy for CNS metastases.
- Has a known history of autoimmune disease, arteritis, or vasculitis, including, but not limited to: lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease (including ulcerative colitis and Crohn's disease), Grave's disease, Hashimoto's thyroiditis, Wegener's granulomatosis, temporal arteritis, and polyarteritis nodosa
- Has a recognized immunodeficiency disease, including cellular immunodeficiencies, hypogammaglobulinemia, or dysgammaglobulinemia; and/or other hereditary or congenital immunodeficiencies
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- Has any preexisting medical condition requiring chronic steroid or immunosuppressive therapy (corticosteroids for COPD or topical steroids are allowed)
- Known to be positive for HIV, hepatitis B, or hepatitis C
- Administration of any other vaccine ≤ 4 weeks prior to study enrollment
Trial locations and contacts
3 sites in 1 country.
United States3 sites
University of Colorado Cancer Center
Aurora, Colorado, 80045
Mary Crowley Cancer Research Center
Dallas, Texas, 75201
Northwest Medical Specialties, PLLC
Tacoma, Washington, 98405
About this study
Official title: Phase 1 Study of ONT-10, a Liposomal MUC1 Cancer Vaccine, in Patients With Solid Tumors
Open label, two part, Phase 1 dose escalation study to evaluate the safety and immunogenicity of repeat dose vaccination with ONT-10 in patients with previously treated Stage 3 or 4 solid tumors. Part 1 to evaluate escalating dose levels of ONT-10 administered subcutaneously every two weeks (Q2W) or weekly (QW) over 8 weeks. Part 2 evaluates the safety, immunogenicity, and potential anti-tumor activity of ONT-10 administered over 8 weeks at the Q2W and QW maximum tolerated does/recommended dose (MTD/RD) in cohorts of 15 patients each.
Read the detailed description
This open label, two part, Phase 1 dose escalation study will evaluate the safety and immunogenicity of repeat dose vaccination with ONT-10 in patients with previously treated Stage 3 or 4 solid tumors with histologies that have been associated with expression of the MUC1 antigen as described in the medical literature. Part 1 will evaluate escalating dose levels of ONT-10 administered subcutaneously Q2W over 8 weeks (for a total of 4 doses) or QW over 8 weeks (for a total of 8 doses) to identify a MTD and/or RD for each dosing schedule, for further evaluation in Part 2 of the study. Part 2 will evaluate the safety, immunogenicity, and potential anti-tumor activity of ONT-10 administered over 8 weeks at the Q2W and QW MTD/RD in cohorts of 15 patients each.
- Conditions
- Solid Tumors
- Being tested
- ONT-10
- Keywords
- ONT-10, MUC1, Vaccine, Phase 1, Solid Tumors, Dose escalation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ONT-10Biological
ONT-10 a liposomal synthetic glycolipopeptide antigen formulated with PET Lipid A adjuvant.
| Study group | Role | What they receive |
|---|---|---|
| ONT-10 Vaccine | Experimental | ONT-10 investigational agent Receives: Biological: ONT-10 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety
Assessment of adverse events and laboratory abnormalities
Measured: 20 weeks
Secondary outcomes (1)
Immunogenicity
Assessments to include evaluation of humoral and cellular immune response.
Measured: 20 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2012 (estimated)
- Study startMar 2013
- Primary completionMay 2015
- Study completionSep 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid TumorsStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 85 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cascadian Therapeutics Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Diana Hausman, MD, Study chair, Cascadian Therapeutics Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01556789
- Sponsor's protocol ID
- ONT-10-001
- Status last verified
- Sep 2015
- First submitted
- 14 Mar 2012
- Last updated
- 17 May 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1 Study of ONT-10, a Liposomal MUC1 Cancer Vaccine, in Patients With Solid Tumors
- ClinicalTrials.gov ID
- NCT01556789
- Acronym / sponsor ID
- ONT-10-001
- Conditions
- Solid Tumors
- Keywords
- ONT-10, MUC1, Vaccine, Phase 1, Solid Tumors, Dose escalation
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 85 participants (actual)
- Lead sponsor
- Cascadian Therapeutics Inc.Industry (pharma, biotech, devices)
- Study start
- Mar 2013
- Primary completion
- May 2015 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 16 Mar 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.
Open label, two part, Phase 1 dose escalation study to evaluate the safety and immunogenicity of repeat dose vaccination with ONT-10 in patients with previously treated Stage 3 or 4 solid tumors. Part 1 to evaluate escalating dose levels of ONT-10 administered subcutaneously every two weeks (Q2W) or weekly (QW) over 8 weeks. Part 2 evaluates the safety, immunogenicity, and potential anti-tumor activity of ONT-10 administered over 8 weeks at the Q2W and QW maximum tolerated does/recommended dose (MTD/RD) in cohorts of 15 patients each.
Detailed description
This open label, two part, Phase 1 dose escalation study will evaluate the safety and immunogenicity of repeat dose vaccination with ONT-10 in patients with previously treated Stage 3 or 4 solid tumors with histologies that have been associated with expression of the MUC1 antigen as described in the medical literature. Part 1 will evaluate escalating dose levels of ONT-10 administered subcutaneously Q2W over 8 weeks (for a total of 4 doses) or QW over 8 weeks (for a total of 8 doses) to identify a MTD and/or RD for each dosing schedule, for further evaluation in Part 2 of the study. Part 2 will evaluate the safety, immunogenicity, and potential anti-tumor activity of ONT-10 administered over 8 weeks at the Q2W and QW MTD/RD in cohorts of 15 patients each.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ONT-10 Vaccine | Experimental | Biological: ONT-10ONT-10 investigational agent |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Be 18 to 70 years of age at time of consent
- Life expectancy of at least 6 months, in the opinion of the investigator
- A) Have histologically confirmed breast, non-small cell lung, ovarian, colorectal, gastric, prostate, pancreatic, or renal cell cancer, or other tumor type as approved by the study medical monitor (Part 1) B) Have histologically confirmed breast or ovarian carcinoma (Part 2)
- Have evidence of persistent, recurrent, or progressive disease after at least one course of systemic therapy for locally advanced or metastatic disease, including chemotherapy, targeted therapy, or immunotherapy
- Clinical stage 3 or 4 disease
Key exclusion criteria (9 listed)
- Has medical, social, or psychosocial factors that, in the opinion of the investigator, could impact safety or compliance with study procedures
- Is pregnant, breastfeeding, or planning a pregnancy
- Has received treatment with any systemic chemotherapy, radiation, or experimental agent within 4 weeks of study drug dosing
- Has untreated or uncontrolled central nervous system (CNS) metastases, including patients who require glucocorticoid therapy for CNS metastases.
- Has a known history of autoimmune disease, arteritis, or vasculitis, including, but not limited to: lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease (including ulcerative colitis and Crohn's disease), Grave's disease, Hashimoto's thyroiditis, Wegener's granulomatosis, temporal arteritis, and polyarteritis nodosa
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 |
|---|---|---|
| ONT-10ONT-10 a liposomal synthetic glycolipopeptide antigen formulated with PET Lipid A adjuvant. | Biological | ONT-10 Vaccine |
Primary outcome
Safety
Time frame: 20 weeks
Assessment of adverse events and laboratory abnormalities
1 secondary outcome
Immunogenicity
Time frame: 20 weeks
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 2018.
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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.
Diana Hausman, MD study chair
Cascadian Therapeutics Inc.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ONT-10 in people with Solid Tumors, run by Cascadian Therapeutics Inc. at 3 sites 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 11 inclusion and 9 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 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
Safety (time frame: 20 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2018.