Actively Recruiting
Safety Study of MELK Inhibitor to Treat Patients With Advanced Breast Cancer and Triple Negative Breast Cancer
Led by OncoTherapy Science, Inc. · Updated on 2026-02-25
70
Participants Needed
8
Research Sites
535 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Safety Study of MELK Inhibitor to Treat Patients With Advanced Breast Cancer and Triple Negative Breast Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female patients 18 years or older
- Diagnosed with histologically or cytologically confirmed locally advanced or metastatic breast cancer
- Relapsed or refractory to standard therapy or no standard therapy available
- Cancer not suitable for surgery due to medical reasons or tumor non-resectability
- Presence of measurable or non-measurable disease per RECIST v1.1
- ECOG performance status of 0 or 1
- Life expectancy of at least 3 months
- Chemotherapy or radiation toxicities resolved to Grade 1 or lower, except stable sensory neuropathy Grade 2 or less
- Not of childbearing potential or agree to use effective contraception during and for 3 months after study
- Ability to understand and provide written informed consent
- For TNBC cohort: ER <10%, PR <10%, HER2 negative per ASCO CAP guidelines
- Measurable disease per RECIST v1.1 suitable for biopsy
- Relapsed or refractory disease with prior initial therapy including at least one active TNBC regimen such as anthracyclines, taxanes, platinum agents, Ixabepilone, or cyclophosphamide
You will not qualify if you...
- Pregnant or lactating women; women of childbearing potential not using adequate birth control
- Uncontrolled central nervous system or leptomeningeal metastases requiring treatment
- Primary brain tumors
- Any hematologic malignancy including leukemia, lymphoma, multiple myeloma
- Baseline hematologic abnormalities: ANC < 1,500/mm3, platelet count < 100,000/mm3, hemoglobin < 8.0 gm/dL
- Baseline serum chemistry abnormalities: bilirubin ≥1.5× ULN, AST or ALT ≥3× ULN (≥5× if due to tumor), creatinine ≥1.5× ULN or creatinine clearance <60 mL/min/1.73 m2
- Significant active cardiovascular disease or conditions including CHF, arrhythmias, severe conduction disturbance, unstable angina, abnormal QTc intervals, reduced LVEF <50%, uncontrolled hypertension, NYHA Class III or IV, or recent myocardial infarction within 6 months
- Known hypersensitivity to OTS167 components
- Known HIV or active hepatitis B or C infections
- Serious or uncontrolled infections or unexplained fever >38°C within 1 week prior to treatment
- Inadequate recovery from prior surgery or major surgery within 4 weeks prior to treatment
- Other life-threatening illnesses, significant organ dysfunction, or clinically significant lab abnormalities
- Psychiatric disorders or altered mental status interfering with consent or study compliance
- Inability or foreseeable incapacity to comply with study protocol
- Antineoplastic or monoclonal antibody therapy within 2 weeks prior to treatment
- Radiotherapy within 4 weeks (wide field) or 1 week (limited field for palliation) prior to treatment
- Need for surgery for primary or metastatic malignancy
- Use of herbal or related supplements within 1 week prior to and during study
- Systemic hormonal therapy unrelated to breast cancer treatment within 1 week prior to and during study except specified allowed therapies
- Participation in other investigational treatments during study
- For TNBC cohort: lesions not accessible for biopsy
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 8 locations
1
Norwalk Hospital
Norwalk, Connecticut, United States, 06856
Completed
2
Emory University, Winship Cancer Institute
Atlanta, Georgia, United States, 30322
Actively Recruiting
3
Kapi'olani Medical Center for Women & Children
Honolulu, Hawaii, United States, 96826
Actively Recruiting
4
Dartmouth Cancer Center/Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, United States, 03756
Actively Recruiting
5
Weill Cornell Medicine | NewYork-Presbyterian
New York, New York, United States, 10065
Completed
6
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 11065
Completed
7
MD Anderson Cancer Center
Houston, Texas, United States, 77030
Completed
8
Froedtert Hospital & the Medical College of Wisconsin
Milwaukee, Wisconsin, United States, 53226
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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