- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01978964
Phase 1b Maintenance Therapy Study of ONT-10 in Patients With Solid Tumors
May 14, 2018 updated by: Cascadian Therapeutics Inc.
Maintenance Therapy With ONT-10, a Liposomal MUC1 Cancer Vaccine, in Patients Who Have Previously Received ONT-10
This is an open label phase 1b maintenance therapy study to evaluate the long-term safety, immunogenicity, and anti-tumor effects of repeat-dose vaccination with ONT-10 in patients who have demonstrated safety and clinical benefit on the original ONT-10-001 phase 1 study.
Study Overview
Detailed Description
Open label Phase 1b maintenance therapy study to evaluate the long-term safety, immunogenicity, and anti-tumor effects 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.
Patients must have previously been enrolled on the Phase 1 clinical trial ONT-10-001, completed all treatment and follow-up through at least 12 weeks, experienced no dose limiting toxicity, and experienced no progression of disease per the immune-related Response Criteria.
Patients will receive maintenance ONT-10 every 6 weeks.
Study Type
Interventional
Enrollment (Anticipated)
90
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
-
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Texas
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Dallas, Texas, United States, 75201
- Mary Crowley Cancer Research Centers
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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 to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
Was enrolled on the Phase 1 clinical trial ONT-10-001 and:
- completed all treatment and follow-up through at least 12 weeks
- experienced no dose limiting toxicity (DLT)
- experienced no progression of disease per the irRC1
- Patients enrolling in the retreatment cohort may have experienced localized disease progression that was treated with definitive therapy to return the patient to a state of stable disease. Examples include localized disease progression treated with complete surgical resection, a solitary brain metastasis treated with complete surgical resection or curative intent stereotactic radiosurgery, or a solitary bone metastasis that is treated with curative-dose radiation therapy.
- Patients enrolling on the retreatment cohort must have locally and systemically stable disease following the definite local treatment.
- Last received ONT-10 a maximum of 6 months (unless approved by the medical monitor) prior to receiving the first dose of maintenance or retreatment cohort therapy
- ECOG 0 or 1
- Adequate baseline hematological parameters as defined by white blood cell count (WBC) ≥ 3.5 x 103/µL, lymphocyte count ≥ 1.0 x 103/µL, platelet count ≥ 100 x 103/µL, and hemoglobin ≥ 9 g/dL
- Adequate hepatic parameters as defined by total bilirubin ≤ 1.5 x upper limit of normal (ULN) and aspartate aminotransferase (AST/SGOT) and alanine aminotransferase (ALT/SGPT) ≤ 3 x ULN
- Serum creatinine ≤ 1.5 x ULN
- Resolution of all prior ONT-10 related toxicities to ≤ Grade 1in severity
- 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)
Exclusion Criteria:
- Has medical, social, or psychosocial factors that, in the opinion of the investigator, could impact safety or compliance with study procedures
- Received treatment with any systemic chemotherapy, experimental agent, or radiation therapy (with the exception of palliative localized radiation therapy) following completion of treatment on the ONT-10-001 study
- 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 untreated or uncontrolled central nervous system (CNS) metastases, including patients who require glucocorticoid therapy for CNS metastases
- Known immunodeficiency disease, including cellular immunodeficiencies, hypogammaglobulinemia, or dysgammaglobulinemia; and/or other hereditary or congenital immunodeficiencies
- Chronic steroid or immunosuppressive therapy (except for low dose corticosteroids for chronic obstructive pulmonary disease [COPD] or topical steroids, which are allowed)
- Known to be positive for human immunodeficiency virus (HIV), hepatitis B, or hepatitis C
- Administration of any vaccine ≤ 4 weeks prior to first maintenance or retreatment cohort dose of ONT-10 with the exception of influenza, pneumococcus, and Tdap
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: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: ONT-10 Vaccine
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ONT-10 is a liposomal synthetic glycopolypeptide antigen formulated with PET Lipid A adjuvant
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Incidence and severity of adverse events and lab abnormalities
Time Frame: 20-60 weeks
|
20-60 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Immunogenicity and anti-tumor activity
Time Frame: 20-60 weeks
|
Assessments of humoral and cellular immune response and overall response as per irRC and RECIST 1.1.
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20-60 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: John Nemunaitis, MD, Mary Crowley Cancer Research Centers
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
November 1, 2012
Primary Completion (Actual)
March 1, 2016
Study Completion (Actual)
March 1, 2016
Study Registration Dates
First Submitted
November 1, 2013
First Submitted That Met QC Criteria
November 7, 2013
First Posted (Estimate)
November 8, 2013
Study Record Updates
Last Update Posted (Actual)
May 17, 2018
Last Update Submitted That Met QC Criteria
May 14, 2018
Last Verified
March 1, 2016
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- ONT-10-002
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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