Safety Study of MELK Inhibitor to Treat Patients With Advanced Breast Cancer and Triple Negative Breast Cancer

NCT02926690 | Recruiting Phase 1 FDA Drug

• 1 other identifier: OTS1070103
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 8

Brief 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.

Conditions

Relapsed/Refractory Locally Advanced or Metastatic Breast Cancer and Triple Negative Breast Cancer

Outcome Measures

Primary Outcomes (1)

• MTD

  During Cycle1 after the first administration

Study Arms (1)

OTS167PO

EXPERIMENTAL

Drug: OTS167PO

Interventions

OTS167PO DRUG

Single arm, no competitor

OTS167PO

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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:
• Female patients, ≥ 18 years of age at the time of obtaining informed consent.
• Patients with a documented (histologically- or cytologically-proven) breast cancer that is locally advanced or metastatic.
• Patients with a malignancy that is either relapsed/refractory to standard therapy or for which no standard therapy is available.
• Patients with a malignancy that is currently not amenable to surgical intervention due to either medical contraindications or non-resectability of the tumor.
• Patients with measurable or non-measurable disease according to the Response Evaluation Criteria In Solid Tumor (RECIST, v1.1).
• Patients with an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1 (see APPENDIX B: Performance Status Evaluation).
• Life expectancy of greater than or equal to 3 months.
• Resolution of all chemotherapy-related or radiation-related toxicities to Grade 1 severity or lower, except for stable sensory neuropathy (less than or equal to Grade 2).
• Patients who are either not of childbearing potential or who agree to use a medically effective method of contraception during the study and during 3 months after the last dose of study drug. (See Appendix H: Forms of contraception).
• Patients with the ability to understand and give written informed consent for participation in this trial, including all evaluations and procedures as specified by this protocol.
• Dose expansion Cohort - TNBC
• Patients with conditions as follows:
• ER \<10%, PR \<10% by IHC assay; And

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.
• Women who are pregnant or lactating. Women of child-bearing potential (WOCBP) not using adequate birth control see Appendix H: Forms of contraception.
• 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.
• Patients with primary brain tumors.
• Patients with any hematologic malignancy. This includes leukemia (any form), lymphoma, and multiple myeloma.
• 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
• Hemoglobin \< 8.0 gm/dL
• 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\* )
• Patients with a significant active cardiovascular disease or condition, including:
• Congestive heart failure (CHF)requiring therapy

Sponsors & Collaborators

• OncoTherapy Science, Inc.: lead

Study Sites (8)

Norwalk Hospital

Norwalk, Connecticut, 06856, United States

COMPLETED

Emory University, Winship Cancer Institute

Atlanta, Georgia, 30322, United States

RECRUITING

Kapi'olani Medical Center for Women & Children

Honolulu, Hawaii, 96826, United States

RECRUITING

Dartmouth Cancer Center/Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, 03756, United States

RECRUITING

Weill Cornell Medicine | NewYork-Presbyterian

New York, New York, 10065, United States

COMPLETED

Memorial Sloan Kettering Cancer Center

New York, New York, 11065, United States

COMPLETED

MD Anderson Cancer Center

Houston, Texas, 77030, United States

COMPLETED

Froedtert Hospital & the Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

RECRUITING

MeSH Terms

Conditions

Recurrence; Breast Neoplasms; Triple Negative Breast Neoplasms

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 5, 2016
• First Posted: October 6, 2016
• Study Start: May 29, 2017
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): September 1, 2027
• Last Updated: February 25, 2026

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (8)