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

NCT01556789 | Completed Phase 1 DMC

• 1 other identifier: ONT-10-001
• Study Type: interventional
• Target: 85
• Locations: 1 country
• Sites: 3

Brief 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. 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.

Conditions

Solid Tumors

Keywords

ONT-10; MUC1; Vaccine; Phase 1; Solid Tumors; Dose escalation

Outcome Measures

Primary Outcomes (1)

• Safety

  Assessment of adverse events and laboratory abnormalities

  20 weeks

Secondary Outcomes (1)

• Immunogenicity

  20 weeks

Study Arms (1)

ONT-10 Vaccine

EXPERIMENTAL

ONT-10 investigational agent

Biological: ONT-10

Interventions

ONT-10 BIOLOGICAL

ONT-10 a liposomal synthetic glycolipopeptide antigen formulated with PET Lipid A adjuvant.

ONT-10 Vaccine

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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)

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Cascadian Therapeutics Inc.: lead

Study Sites (3)

University of Colorado Cancer Center

Aurora, Colorado, 80045, United States

Location

Mary Crowley Cancer Research Center

Dallas, Texas, 75201, United States

Location

Northwest Medical Specialties, PLLC

Tacoma, Washington, 98405, United States

Location

Study Officials

• Diana Hausman, MD

  Cascadian Therapeutics Inc.

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 14, 2012
• First Posted: March 16, 2012
• Study Start: March 1, 2013
• Primary Completion: May 1, 2015
• Study Completion: September 1, 2015
• Last Updated: May 17, 2018

Record last verified: 2015-09

Locations

US (3)