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

Recruiting now · Phase 1

Conditions studied: Relapsed/Refractory Locally Advanced or Metastatic Breast Cancer and Triple Negative Breast Cancer

In brief

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.

Key facts

Study ID: NCT02926690
Run by: OncoTherapy Science, Inc.
People needed: 70
Starts: 2017-05-29
Expected to finish: 2027-09-01
Last updated by the study team: 2026-02-25

Who can join

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

You may qualify if…

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.
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.

You may not qualify if…

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.):
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

Where it is running

Emory University, Winship Cancer Institute — Atlanta, Georgia, United States (enrolling)
Kapi'olani Medical Center for Women & Children — Honolulu, Hawaii, United States (enrolling)
Dartmouth Cancer Center/Dartmouth-Hitchcock Medical Center — Lebanon, New Hampshire, United States (enrolling)
Froedtert Hospital & the Medical College of Wisconsin — Milwaukee, Wisconsin, United States (enrolling)
Weill Cornell Medicine | NewYork-Presbyterian — New York, New York, United States
Norwalk Hospital — Norwalk, Connecticut, United States
Memorial Sloan Kettering Cancer Center — New York, New York, United States
MD Anderson Cancer Center — Houston, Texas, United States

Full record on ClinicalTrials.gov

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