RecruitingRelapsed/Refractory Locally Advanced or Metastatic Breast Cancer and Triple Negative Breast Cancer
Safety Study of MELK Inhibitor to Treat Patients With Advanced Breast Cancer and Triple Negative Breast Cancer
Eligible age
18+ yrs
Accepts
All genders
Locations
7 states
Healthy volunteers
No
See if you qualify for this study
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About this study
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.
Sponsor: OncoTherapy Science, Inc.
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:
- ✓ 1. Female patients, ≥ 18 years of age at the time of obtaining informed consent.
- ✓ 2. Patients with a documented (histologically- or cytologically-proven) breast cancer that is locally advanced or metastatic.
- ✓ 3. Patients with a malignancy that is either relapsed/refractory to standard therapy or for which no standard therapy is available.
- ✓ 4. Patients with a malignancy that is currently not amenable to surgical intervention due to either medical contraindications or non-resectability of the tumor.
- ✓ 5. Patients with measurable or non-measurable disease according to the Response Evaluation Criteria In Solid Tumor (RECIST, v1.1).
- ✓ 6. Patients with an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1 (see APPENDIX B: Performance Status Evaluation).
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.
- ✕ 1. Women who are pregnant or lactating. Women of child-bearing potential (WOCBP) not using adequate birth control see Appendix H: Forms of contraception.
- ✕ 2. 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.
- ✕ 3. Patients with primary brain tumors.
- ✕ 4. Patients with any hematologic malignancy. This includes leukemia (any form), lymphoma, and multiple myeloma.
- ✕ 5. 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
Where it's recruiting
Connecticut
Norwalk
Georgia
Atlanta
Hawaii
Honolulu
New Hampshire
Lebanon
New York
New York
Texas
Houston
Wisconsin
Milwaukee
Source: ClinicalTrials.gov · NCT02926690 · last updated 2026-02-25