Safety Study of OTS167 for Advanced Breast Cancer and Triple Negative Breast Cancer
This study is testing the safety of a drug called OTS167 in people with advanced breast cancer or triple negative breast cancer that has returned or spread. The main goal is to find the highest dose of OTS167 that patients can tolerate (MTD). You might be able to join if you are a female at least 18 years old with documented locally advanced or metastatic breast cancer. This study is currently recruiting about 70 participants, but its exact status is unclear.
- Study design
- This is a single-arm study, meaning all participants will receive the same treatment. It plans to enroll 70 participants.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- The primary endpoint, MTD, is measured during Cycle 1 after the first administration of the drug.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
NCT02926690
Safety Study of MELK Inhibitor to Treat Patients With Advanced Breast Cancer and Triple Negative Breast Cancer
Recruiting
PHASE1Ages 18+InterventionalTreatmentOncoTherapy Science, Inc.
~70 participants
Updated 2026-02-25 on ClinicalTrials.gov
What's tested:OTS167PO
At a glance
Recruiting sites
4 of 8 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
MTD
Measured over During Cycle1 after the first administration
Conditions
Where it's being run
8 sites across 7 statesNew York2
Connecticut1
Georgia1
Hawaii1
New Hampshire1
Texas1
Wisconsin1
Who to contact
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Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
ER \<10%, PR \<10% by IHC assay; And
HER2 negative based on ASCO CAP guideline 2. Patients with measurable disease according to the response evaluation criteria in TNBC (RECIST, v1.1) 3. Patients with measurable disease that can be easily accessed for biopsy. 4. 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.
Exclusion
Absolute neutrophil count (ANC) \< 1,500 per mm3
Platelet count \< 100,000 per mm3
Hemoglobin \< 8.0 gm/dL 6. 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\* ) 7. 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 8. Patients with a known or suspected hypersensitivity to any of the components of OTS167. 9. Patients with a known history of human immunodeficiency virus (HIV) or active infection with hepatitis B virus (HBV) or hepatitis C virus (HCV). 10. 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. 11. 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. 12. 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. 13. 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. 14. Patients with the inability or with foreseeable incapacity, in the opinion of the Investigator, to comply with the protocol requirements. 15. Any anti-neoplastic agent or monoclonal antibody therapy for the primary malignancy (standard or experimental) within 2 weeks prior to first study drug administration. 16. 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. 17. Patients requiring surgery for the primary or metastatic primary malignancy. 18. 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. 19. 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) 20. Any other investigational treatments during study. This includes participation in any medical device or therapeutic intervention clinical trials.
What this trial measures
- MTDDuring Cycle1 after the first administration