OncoMatch/Clinical Trials/NCT02926690
Safety Study of MELK Inhibitor to Treat Patients With Advanced Breast Cancer and Triple Negative Breast Cancer
Is NCT02926690 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies OTS167PO for relapsed/refractory locally advanced or metastatic breast cancer and triple negative breast cancer.
Treatment: OTS167PO — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Triple-Negative Breast Cancer
Breast Carcinoma
Biomarker criteria
Required: ESR1 expression <10% by IHC (<10%)
ER <10% by IHC assay
Required: PR (PGR) expression <10% by IHC (<10%)
PR <10% by IHC assay
Required: HER2 (ERBB2) negative based on ASCO CAP guideline (negative)
HER2 negative based on ASCO CAP guideline
Disease stage
Metastatic disease required
locally advanced or metastatic; not amenable to surgical intervention
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: cytotoxic chemotherapy (anthracyclines, taxanes, platinum agents, ixabepilone, cyclophosphamide) — 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
Cannot have received: anti-neoplastic agent or monoclonal antibody therapy
Any anti-neoplastic agent or monoclonal antibody therapy for the primary malignancy (standard or experimental) within 2 weeks prior to first study drug administration
Cannot have received: radiation therapy
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
Lab requirements
Blood counts
ANC ≥ 1,500 per mm3; Platelet count ≥ 100,000 per mm3; Hemoglobin ≥ 8.0 gm/dL
Kidney function
Creatinine < 1.5 × ULN (or calculated creatinine clearance ≥ 60 mL/min/1.73 m2)
Liver function
Total bilirubin < 1.5 × ULN; AST or ALT < 3 × ULN (< 5 × if due to hepatic involvement by tumor)
Cardiac function
No significant active cardiovascular disease or condition, including: CHF requiring therapy, need for antiarrhythmic therapy for 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%, uncontrolled hypertension, NYHA Class III or IV, MI within 6 months
See exclusion criteria 5, 6, 7
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Norwalk Hospital · Norwalk, Connecticut
- Emory University, Winship Cancer Institute · Atlanta, Georgia
- Kapi'olani Medical Center for Women & Children · Honolulu, Hawaii
- Dartmouth Cancer Center/Dartmouth-Hitchcock Medical Center · Lebanon, New Hampshire
- Weill Cornell Medicine | NewYork-Presbyterian · New York, New York
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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