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

Sponsor

Cascadian Therapeutics Inc. (Industry)

Overall Status

Completed

CT.gov ID

NCT01556789

Collaborator

(none)

Enrollment

Locations

Arm

Duration (Months)

28.3

Patients Per Site

0.9

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Solid Tumors	Biological: ONT-10	Phase 1

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

Study Type:

Interventional

Actual Enrollment :

85 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Mar 1, 2013

Actual Primary Completion Date :

May 1, 2015

Actual Study Completion Date :

Sep 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Experimental: ONT-10 Vaccine ONT-10 investigational agent	Biological: ONT-10 ONT-10 a liposomal synthetic glycolipopeptide antigen formulated with PET Lipid A adjuvant.

Arm

Intervention/Treatment

Experimental: ONT-10 Vaccine

ONT-10 investigational agent

Biological: ONT-10

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

Outcome Measures

Primary Outcome Measures

Safety [20 weeks]
Assessment of adverse events and laboratory abnormalities

Secondary Outcome Measures

Immunogenicity [20 weeks]
Assessments to include evaluation of humoral and cellular immune response.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Be 18 to 70 years of age at time of consent
Life expectancy of at least 6 months, in the opinion of the investigator
1. 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)

Exclusion Criteria:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Colorado Cancer Center	Aurora	Colorado	United States	80045
2	Mary Crowley Cancer Research Center	Dallas	Texas	United States	75201
3	Northwest Medical Specialties, PLLC	Tacoma	Washington	United States	98405