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Relapsed/Refractory Locally Advanced or Metastatic Breast Cancer and Triple Negative Breast CancerPhase 1NCT02926690

Safety Study of MELK Inhibitor to Treat Patients With Advanced Breast Cancer and Triple Negative Breast Cancer

A Phase 1 study testing OTS167PO in people with Relapsed/Refractory Locally Advanced or Metastatic Breast Cancer and Triple Negative Breast Cancer, run by OncoTherapy Science, Inc. at 8 sites in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

The purpose of this study is to determine the maximum tolerated dose (MTD) of OTS167 administered via oral capsule (PO) to patients with relapsed/refractory locally advanced or metastatic breast cancer. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
OTS167PO
Could I receive a placebo?
No, everyone receives an active treatment
How many people
70 participants
Where
8 sitesUnited States
Study dates
29 May 2017to Sep 2027
Phase
Phase 1
Are there results?
Not yet: the study is under way

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

  • Dose Escalation and Dose Expansion Cohorts
  • Patients must meet all of the following criteria to be eligible for participation in the study:
  • Female patients, ≥ 18 years of age at the time of obtaining informed consent.
  • Patients with a documented (histologically- or cytologically-proven) breast cancer that is locally advanced or metastatic.
  • Patients with a malignancy that is either relapsed/refractory to standard therapy or for which no standard therapy is available.
  • Patients with a malignancy that is currently not amenable to surgical intervention due to either medical contraindications or non-resectability of the tumor.
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  • Patients with measurable or non-measurable disease according to the Response Evaluation Criteria In Solid Tumor (RECIST, v1.1).
  • Patients with an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1 (see APPENDIX B: Performance Status Evaluation).
  • Life expectancy of greater than or equal to 3 months.
  • Resolution of all chemotherapy-related or radiation-related toxicities to Grade 1 severity or lower, except for stable sensory neuropathy (less than or equal to Grade 2).
  • Patients who are either not of childbearing potential or who agree to use a medically effective method of contraception during the study and during 3 months after the last dose of study drug. (See Appendix H: Forms of contraception).
  • Patients with the ability to understand and give written informed consent for participation in this trial, including all evaluations and procedures as specified by this protocol.
  • Dose expansion Cohort - TNBC
  • Patients with conditions as follows:
  • ER <10%, PR <10% by IHC assay; And
  • HER2 negative based on ASCO CAP guideline
  • Patients with measurable disease according to the response evaluation criteria in TNBC (RECIST, v1.1)
  • Patients with measurable disease that can be easily accessed for biopsy.
  • Relapsed (recurrence or disease progression after achieving a documented clinical response to first- or second-line treatment) or refractory (disease progression while receiving first line or second line treatment). In the case of TNBC, prior initial therapy with at least one known active regimen for TNBC including, but not limited to, any combination of anthracyclines, taxanes, platinum agents, Ixabepilone, and/or cyclophosphamide is required.

Who cannot join

  • Dose Escalation and Dose Expansion Cohorts Patients meeting any of the following criteria are ineligible for participation in the study.
  • Women who are pregnant or lactating. Women of child-bearing potential (WOCBP) not using adequate birth control see Appendix H: Forms of contraception.
  • Patients with known central nervous system (CNS) or leptomeningeal metastases not controlled by prior surgery, radiotherapy or requiring corticosteroids to control symptoms, or patients with symptoms suggesting CNS involvement for which treatment is required.
  • Patients with primary brain tumors.
  • Patients with any hematologic malignancy. This includes leukemia (any form), lymphoma, and multiple myeloma.
  • Patients with any of the following hematologic abnormalities at baseline. (Patients may have received a red blood cell product transfusion prior to study, if clinically warranted.):
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  • Absolute neutrophil count (ANC) < 1,500 per mm3
  • Platelet count < 100,000 per mm3
  • Hemoglobin < 8.0 gm/dL
  • Patients with any of the following serum chemistry abnormalities at baseline:
  • Total bilirubin ≥ 1.5 × the ULN for the institution value
  • AST or ALT ≥ 3 × the ULN for the institution value (≥ 5 × if due to hepatic involvement by tumor)
  • Creatinine ≥ 1.5 × ULN for the institution value (or a calculated creatinine clearance < 60 mL/min/1.73 m2* )
  • Patients with a significant active cardiovascular disease or condition, including:
  • Congestive heart failure (CHF)requiring therapy
  • Need for antiarrhythmic medical therapy for a ventricular arrhythmia
  • Severe conduction disturbance
  • Unstable angina pectoris requiring therapy
  • QTc interval > 450 msec (males) or > 470 msec (females)
  • QTc interval ≤ 300 msec
  • History of congenital long QT syndrome or congenital short QT syndrome
  • LVEF < 50% as measured by echocardiography or MUGA scan
  • Uncontrolled hypertension (per the Investigator's discretion)
  • Class III or IV cardiovascular disease according to the New York Heart Association's (NYHA) Functional Criteria (see APPENDIX C: New York Heart Association's Functional Criteria).
  • Myocardial infarction (MI) within 6 months prior to first study drug administration
  • Patients with a known or suspected hypersensitivity to any of the components of OTS167.
  • Patients with a known history of human immunodeficiency virus (HIV) or active infection with hepatitis B virus (HBV) or hepatitis C virus (HCV).
  • Patients with any other serious/active/uncontrolled infection, any infection requiring parenteral antibiotics, or unexplained fever > 38ºC within 1 week prior to first study drug administration.
  • Patients with inadequate recovery from any prior surgical procedure, or patients having undergone any major surgical procedure within 4 weeks prior to first study drug administration.
  • Patients with any other life-threatening illness, significant organ system dysfunction, or clinically significant laboratory abnormality, which, in the opinion of the Investigator, would either compromise the patient's safety or interfere with evaluation of the safety of the study drug.
  • Patients with a psychiatric disorder or altered mental status that would preclude understanding of the informed consent process and/or completion of the necessary studies.
  • Patients with the inability or with foreseeable incapacity, in the opinion of the Investigator, to comply with the protocol requirements.
  • Any anti-neoplastic agent or monoclonal antibody therapy for the primary malignancy (standard or experimental) within 2 weeks prior to first study drug administration.
  • Radiotherapy with a wide field of radiation within 4 weeks or radiotherapy with a limited field of radiation for palliation within 1 week of the first dose of study treatment. If acute symptoms of radiation have fully resolved, the extent and timing of radiotherapy for eligibility can be discussed between Investigator and Sponsor.
  • Patients requiring surgery for the primary or metastatic primary malignancy.
  • Herbal preparations or related over the counter (OTC) preparations/supplements containing herbal ingredients within 1 week prior to first study drug administration and during study.
  • Systemic hormonal therapy which is not related to breast cancer treatment (standard or experimental) within 1 week prior to first study drug administration and during study. The following therapies are allowed:
  • Hormonal therapy (e.g., Megace) for appetite stimulation
  • Nasal, ophthalmic, inhaled, and topical glucocorticoid preparations
  • Oral replacement glucocorticoid therapy for adrenal insufficiency
  • Low-dose maintenance steroid therapy for other conditions (excluding steroid tapers for brain edema/metastases/radiation)
  • Hormonal contraceptive therapy (for WOCBP must be combined with non-hormonal contraceptive equivalent to a double-barrier method)
  • Any other investigational treatments during study. This includes participation in any medical device or therapeutic intervention clinical trials.
  • Dose expansion Cohort - TNBC
  • Patients with only lesions that cannot be accessed for biopsy.

Trial locations and contacts

8 sites in 1 country. Contact the study team or a site near you to ask about taking part.

8 sites in 1 country

United States8 sites, 4 recruiting

  • Emory University, Winship Cancer Institute

    Atlanta, Georgia, 30322

    Madison Steininger, 404-778-8145, madison.miller.stallings@emory.edu

    Shipra Gandhi, MD, MS

    Recruiting

  • Kapi'olani Medical Center for Women & Children

    Honolulu, Hawaii, 96826

    Robyn Morse, 808-212-3440, robyn.morse@hawaiipacifichealth.org

    Naoto Ueno, MD, PhD, FACP

    Recruiting

  • MD Anderson Cancer Center

    Houston, Texas, 77030

    Completed

  • Dartmouth Cancer Center/Dartmouth-Hitchcock Medical Center

    Lebanon, New Hampshire, 03756

    Courtney Davis, 603-653-9089, Courtney.M.Davis@hitchcock.org

    Lauren Sinks, 603-650-6380, lauren.j.sinks@hitchcock.org

    Recruiting

  • Froedtert Hospital & the Medical College of Wisconsin

    Milwaukee, Wisconsin, 53226

    MCW Cancer Center Clinical Trials Office, 414-805-8900, cccto@mcw.edu

    Yee Chung Cheng, MD

    Recruiting

  • Weill Cornell Medicine | NewYork-Presbyterian

    New York, New York, 10065

    Completed

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 11065

    Completed

  • Norwalk Hospital

    Norwalk, Connecticut, 06856

    Completed

Other trials in United States

About this study

Official title: A Phase I Study of OTS167PO, a MELK Inhibitor, to Evaluate Safety, Tolerability and Pharmacokinetics in Patients With Advanced Breast Cancer and Dose-Expansion Study in Patients With Triple Negative Breast Cancer

The purpose of this study is to determine the maximum tolerated dose (MTD) of OTS167 administered via oral capsule (PO) to patients with relapsed/refractory locally advanced or metastatic breast cancer.

Being tested
OTS167PO
Medical subject headings
Recurrence, Breast Neoplasms, Triple Negative Breast Neoplasms

What participants receive

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

  • OTS167PODrug

    Single arm, no competitor

Study groups in NCT02926690
Study groupRoleWhat they receive
OTS167POExperimentalNot described
Receives: Drug: OTS167PO

What is being measured

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

  1. MTD

    Measured: During Cycle1 after the first administration

Timeline

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

  1. First posted6 Oct 2016 (estimated)
  2. Study start29 May 2017
  3. Primary completionSep 2027 (estimated)
  4. Study completionSep 2027 (estimated)

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
70 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02926690
Sponsor's protocol ID
OTS1070103
Status last verified
Mar 2025
First submitted
5 Oct 2016
Last updated
25 Feb 2026
Results posted
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing OTS167PO in people with Relapsed/Refractory Locally Advanced or Metastatic Breast Cancer and Triple Negative Breast Cancer, run by OncoTherapy Science, Inc. at 8 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 19 inclusion and 45 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: looking for participants now, as of the sponsor's last update on 25 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 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?

This study is still under way. Results are not available in the source record yet.

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

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

MTD (time frame: During Cycle1 after the first administration). 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 NCT02926690.

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 25 Feb 2026.

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