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Phase 1 Study of ONT-10 in Patients With Solid Tumors

This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
Oncothyreon Inc. Identifier:
First received: March 14, 2012
Last updated: November 3, 2014
Last verified: November 2014

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.

Condition Intervention Phase
Solid Tumors
Biological: ONT-10
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase 1 Study of ONT-10, a Liposomal MUC1 Cancer Vaccine, in Patients With Solid Tumors

Resource links provided by NLM:

Further study details as provided by Oncothyreon Inc.:

Primary Outcome Measures:
  • Safety [ Time Frame: 20 weeks ] [ Designated as safety issue: Yes ]
    Assessment of adverse events and laboratory abnormalities

Secondary Outcome Measures:
  • Immunogenicity [ Time Frame: 20 weeks ] [ Designated as safety issue: No ]
    Assessments to include evaluation of humoral and cellular immune response.

Estimated Enrollment: 78
Study Start Date: March 2013
Estimated Study Completion Date: July 2015
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ONT-10 Vaccine
ONT-10 investigational agent
Biological: ONT-10
ONT-10 a liposomal synthetic glycolipopeptide antigen formulated with PET Lipid A adjuvant.

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.


Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Be 18 to 70 years of age at time of consent
  2. Life expectancy of at least 6 months, in the opinion of the investigator
  3. 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)
  4. 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
  5. Clinical stage 3 or 4 disease
  6. ECOG 0 or 1
  7. 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
  8. Have renal and hepatic function laboratory test results not to exceed 1.5 X upper limit of normal (ULN)
  9. If female of child bearing potential, have a negative pregnancy test at screening
  10. 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.
  11. 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:

  1. Has medical, social, or psychosocial factors that, in the opinion of the investigator, could impact safety or compliance with study procedures
  2. Is pregnant, breastfeeding, or planning a pregnancy
  3. Has received treatment with any systemic chemotherapy, radiation, or experimental agent within 4 weeks of study drug dosing
  4. Has untreated or uncontrolled central nervous system (CNS) metastases, including patients who require glucocorticoid therapy for CNS metastases.
  5. 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
  6. Has a recognized immunodeficiency disease, including cellular immunodeficiencies, hypogammaglobulinemia, or dysgammaglobulinemia; and/or other hereditary or congenital immunodeficiencies
  7. Has any preexisting medical condition requiring chronic steroid or immunosuppressive therapy (corticosteroids for COPD or topical steroids are allowed)
  8. Known to be positive for HIV, hepatitis B, or hepatitis C
  9. Administration of any other vaccine ≤ 4 weeks prior to study enrollment
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01556789

United States, Colorado
University of Colorado Cancer Center
Aurora, Colorado, United States, 80045
United States, Texas
Mary Crowley Cancer Research Center
Dallas, Texas, United States, 75201
United States, Washington
Northwest Medical Specialties, PLLC
Tacoma, Washington, United States, 98405
Sponsors and Collaborators
Oncothyreon Inc.
Study Chair: Diana Hausman, MD Oncothyreon Inc.
  More Information

No publications provided

Responsible Party: Oncothyreon Inc. Identifier: NCT01556789     History of Changes
Other Study ID Numbers: ONT-10-001
Study First Received: March 14, 2012
Last Updated: November 3, 2014
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

Keywords provided by Oncothyreon Inc.:
Phase 1
Solid Tumors
Dose escalation

Additional relevant MeSH terms:
Neoplasms processed this record on November 24, 2014