Study of ONT-10 and Varlilumab to Treat Advanced Ovarian or Breast Cancer

Completed · Phase 1

Conditions studied: Advanced Breast Carcinoma, Advanced Ovarian Carcinoma

In brief

This is a two-part Phase 1b, open-label study of ONT 10 administered in combination with varlilumab. Two different doses of varlilumab will be studied in combination with the single agent recommended dose of ONT 10. Intermediate and/or lower doses of varlilumab or ONT-10 may also be studied at the recommendation of the safety monitoring committee (SMC).

Key facts

Study ID: NCT02270372
Run by: Cascadian Therapeutics Inc.
People needed: 22
Starts: 2014-11-01
Expected to finish: 2016-06-01
Last updated by the study team: 2018-05-17

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Be at least 18 years of age at the time of consent
Life expectancy of at least 6 months, in the opinion of the investigator
Have histologically confirmed breast or ovarian carcinoma
Have evidence of persistent, recurrent, or progressive disease for which there is no known or established treatment available with curative intent, after at least one course of systemic therapy for locally advanced or metastatic disease , including chemotherapy, targeted therapy (small molecule or antibody based), or hormonal therapy
Measurable or evaluable disease by RECIST 1.1
ECOG performed status of 0 or 1
Adequate hematologic function defined by:
WBC count ≥ 3.0 x 103 cells/µL
Lymphocyte count ≥ 0.8 x 103 cells/µL
Platelet count ≥ 75 x 103 /µL, and
Hemoglobin ≥ 9 g/dL
Have renal and hepatic function as defined by:
AST and ALT ≤ 2.5 X ULN
Total bilirubin ≤ 1.5 X ULN. Patients with elevated bilirubin known to be due to Gilbert's disease may be enrolled after approval from the medical monitor, and
Creatinine clearance ≥ 50 mL/min
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, abstinence or other methods prescribed by a licensed healthcare provider) from the time of consent through 70 days following the last dose of study drug
Patient or a legally authorized representative of a patient must be able and willing to sign informed consent document that has been approved by an IRB

You may not qualify if…

Has medical, social, or psychological 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 anticancer therapy, wide-field radiation, or experimental agent within 4 weeks of receiving cyclophosphamide on Day -3, with the exception of anticancer hormonal therapy, which may not be given within 2 weeks of receiving cyclophosphamide on Day -3. All residual toxicity related to prior anticancer therapies (excluding vitiligo, endocrinopathies on stable replacement therapy, alopecia and Grade 2 fatigue) must resolve to Grade 1 severity or less or return to baseline prior to receipt of study treatment.
Has received treatment with focal radiotherapy within 2 weeks, or radiopharmaceuticals (e.g., strontium, samarium) within 8 weeks of receiving cyclophosphamide on Day -3
Has untreated or uncontrolled CNS metastases, including patients who require glucocorticoid therapy for CNS metastases
Has received prior treatment with ONT-10 or varlilumab, or prior treatment with other MUC1 vaccines or CD27-targeted agents
Has active autoimmune disease or a documented history of autoimmune disease, or history of potential autoimmune syndrome that required systemic steroids or immunosuppressive medications, except for patients with vitiligo, endocrinopathies, type 1 diabetes, or patients with resolved childhood asthma/atopy or other syndromes which would not be expected to recur in the absence of an external trigger (e.g., drug-related serum sickness or post-streptococcal glomerulonephritis). Patients with mild asthma who require intermittent use of bronchodilators (such as albuterol) who have not been hospitalized for asthma in the preceding 3 years will not be excluded from this study.
Has recognized immunodeficiency disease, including cellular immunodeficiencies, hypogammaglobulinemia, or dysgammaglobulinemia, and/or other hereditary congenital immunodeficiencies
Has any pre-existing medical condition requiring systemic chronic steroid or immunosuppressive therapy
a) Inhaled corticosteroids for COPD or topical steroids are allowed
Known to be positive for HIV, or to have active hepatitis B, or hepatitis C, or have active infection of any kind requiring systemic therapy
Administration of any other vaccine ≤ 4 weeks of receiving cyclophosphamide on Day -3
Underlying medical condition that, in the Investigator's opinion, will make the administration of study treatment hazardous or obscure the interpretation of toxicity determination of adverse events. This includes other prior malignancy, except for adequately treated basal or squamous cell skin cancer or in situ cancer; or any other cancer from which the patient has been disease-free for at least 3 years.
Significant cardiovascular disease including unstable angina pectoris, uncontrolled hypertension (persistent systolic blood pressure > 150 mmHg and/or diastolic blood pressure > 100 mmHg on antihypertensive medications) or arrhythmia, congestive heart failure (NYHA Class III or IV) related to primary cardiac disease, ischemic or severe valvular heart disease, or myocardial infarction within 6 months prior to the first dose of study treatment

Where it is running

UAB Comprehensive Cancer Center — Birmingham, Alabama, United States
University of Colorado — Aurora, Colorado, United States
NYU Perlmutter Cancer Center — New York, New York, United States
Sarah Cannon Research Institute — Nashville, Tennessee, United States

Full record on ClinicalTrials.gov

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