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Advanced Breast CarcinomaPhase 1NCT02270372

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

A Phase 1 study testing ONT-10, Varlilumab combination in people with Advanced Breast Carcinoma and Advanced Ovarian Carcinoma, run by Cascadian Therapeutics Inc. at 4 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
ONT-10, Varlilumab combination
Could I receive a placebo?
No, everyone receives an active treatment
How many people
22 participants
Where
4 sitesUnited States
Study dates
Nov 2014to Jun 2016
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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

Who cannot join

  • 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
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  • 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
  • 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

Trial locations and contacts

4 sites in 1 country.

United States4 sites

  • University of Colorado

    Aurora, Colorado, 80045

  • UAB Comprehensive Cancer Center

    Birmingham, Alabama, 35294

  • Sarah Cannon Research Institute

    Nashville, Tennessee, 37203

  • NYU Perlmutter Cancer Center

    New York, New York, 10016

Other trials in United States

About this study

Official title: A Phase 1b Study of ONT 10 and Varlilumab in Patients With Advanced Ovarian Cancer or Breast Cancer

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).

Read the detailed description

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). Treatment will be administered in cycles of 12 weeks each. All patients will receive a single dose of cyclophosphamide on Day -3. During Cycle 1, patients will receive ONT-10 administered SC once per week for 8 weeks followed by ONT-10 once every 6 weeks starting with Cycle 2, in combination with varlilumab administered IV once every 3 weeks x 3 doses, and then once every 6 weeks for cycles 2 through 5.

Each cohort will enroll an initial group of 6 evaluable patients with either breast or ovarian carcinoma. Initial enrollment into a cohort will be staggered, with the first patient treated in any new cohort to be followed for a minimum of two weeks for the occurrence of Unacceptable Toxicity prior to enrollment of the remaining 5 patients. Subsequent enrollment into a cohort may then continue without a staggered schedule until 6 patients treated are considered evaluable. Up to 24 additional evaluable patients may be enrolled and treated in Part 2 at the RD of varlilumab and ONT-10 identified in Part 1, including approximately equal numbers of patients with breast carcinoma (n~12) and ovarian carcinoma (n~12). Treatment in Part 2 will follow the same schedule as in Part 1.

Being tested
ONT-10, Varlilumab combination
Keywords
Advanced breast carcinoma, Advanced ovarian carcinoma, MUC1, vaccine, Phase 1b

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ONT-10, Varlilumab combinationBiological

    ONT-10 a liposomal synthetic glycopolypeptide MUC1 targeted antigen formulated with PET Lipid A adjuvant.

    Varlilumab is a recombinant, fully human mAb of the IgG1κ isotype that specifically binds human CD27.

Study groups in NCT02270372
Study groupRoleWhat they receive
Drug CombinationExperimentalThe drug combination of ONT-10 and varilumab
Receives: Biological: ONT-10, Varlilumab combination

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of participants with adverse events as a measure of safety and tolerability

    Assessment of the adverse event profile as an indication of overall safety and tolerability of the combination treatment with ONT-10 and varlilumab

    Measured: Cycles of 12 weeks

Secondary outcomes (1)

  1. Immune Response to MUC1

    Determine the immune response of the drug combination of varlilumab and ONT-10 to MUC1 specific humoral and cellular responses.

    Measured: 8 weeks on a weekly basis, followed by every 6 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Oct 2014 (estimated)
  2. Study startNov 2014
  3. Primary completionJun 2016
  4. Study completionJun 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
22 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02270372
Sponsor's protocol ID
ONT-10-104
Status last verified
Aug 2016
First submitted
14 Oct 2014
Last updated
17 May 2018
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing ONT-10, Varlilumab combination in people with Advanced Breast Carcinoma and Advanced Ovarian Carcinoma, run by Cascadian Therapeutics Inc. at 4 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 18 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 May 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of participants with adverse events as a measure of safety and tolerability (time frame: Cycles of 12 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02270372.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 May 2018.

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