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
OncoTherapy Science, Inc.
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.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 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…
Interventions
- DrugOTS167PO
Single arm, no competitor
Locations (8)
- Norwalk HospitalNorwalk, Connecticut
- Emory University, Winship Cancer InstituteAtlanta, Georgia
- Kapi'olani Medical Center for Women & ChildrenHonolulu, Hawaii
- Dartmouth Cancer Center/Dartmouth-Hitchcock Medical CenterLebanon, New Hampshire
- Weill Cornell Medicine | NewYork-PresbyterianNew York, New York
- Memorial Sloan Kettering Cancer CenterNew York, New York