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Phase 1 Study of ONT-10, a Liposomal MUC1 Cancer Vaccine, in Patients With Solid Tumors

Phase 1
18 Years
70 Years
Open (Enrolling)
Solid Tumors

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Trial Information

Phase 1 Study of ONT-10, a Liposomal MUC1 Cancer Vaccine, in Patients With Solid Tumors

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.

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. 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

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

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.

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. Known to be positive for HIV, hepatitis B, or hepatitis C

5. Administration of any other vaccine ≤ 4 weeks prior to study enrollment

Type of Study:


Study Design:

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:


Outcome Description:

Assessment of adverse events and laboratory abnormalities

Outcome Time Frame:

20 weeks

Safety Issue:


Principal Investigator

Diana Hausman, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Oncothyreon Inc.


United States: Food and Drug Administration

Study ID:




Start Date:

March 2013

Completion Date:

June 2014

Related Keywords:

  • Solid Tumors
  • ONT-10
  • MUC1
  • Vaccine
  • Phase 1
  • Solid Tumors
  • Dose escalation
  • Neoplasms



Mary Crowley Cancer Research CenterDallas, Texas  75246