Clinical Trials for Breast Cancer

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

No known activity

No investigational drug(s) in this trial have shown anticancer activity yet in clinical trials

High burden on patient

The trial has a high burden on patients. An example would be a phase 1 trial with extra tumor biopsies and frequent pharmacokinetic blood draws.

Started >3 years ago

The trial was activated more than 3 years ago. This is not always bad but can indicate that the trial has less current treatments, or has had trouble getting enough patients to enroll due to other issues.

TrialFetch AI summary: Eligible patients are adult women with relapsed/refractory locally advanced or metastatic breast cancer (ECOG 0–1) who have progressed after standard therapies or lack standard options; a dose-expansion cohort is restricted to measurable triple-negative disease (ER/PR <10%, HER2-negative) previously treated with at least one active TNBC regimen and with a biopsiable lesion. All participants receive oral OTS167PO, an investigational small-molecule inhibitor of maternal embryonic leucine zipper kinase (MELK), in single-arm dose escalation to define MTD with PK/safety characterization and TNBC expansion at the selected dose.

ClinicalTrials.gov ID: NCT02926690