OHSU Knight Cancer Institute

IRB #

STUDY00022225

Title

A Phase I Dose Escalation and Dose Expansion and Phase II Monotherapy Open-label, First-in-Human, Multicenter Study of OP-1250 in Adult Subjects with Advanced and/or Metastatic Hormone Receptor (HR)-positive, HER2-negative Breast Cancerr

Principal Investigator

Alexandra Zimmer

Study Purpose

This clinical trial is a Phase I, open-label, multi-center, dose-escalation and dose expansion study evaluating the safety, pharmacokinetics, pharmacodynamics, and antitumor activity of daily oral administration of OP-1250.

Medical Condition(s)

Advanced and/or Metastatic Hormone Receptor (HR)-positive, HER2-negative Breast Cancer

Eligibility Criteria

18 years old or older

Have histologically or cytologically confirmed locally advanced or metastatic breast cancer for which standard curative measures do not exist

Must have received at least one prior hormonal regimens for locally advanced or metastatic disease

Must not have received prior oral endocrine therapy more than 2 weeks prior to first dose of investigational therapy

Must not have received prior fulvestrant, chemotherapy, antibody therapy, or investigational therapy within 4 weeks prior to the first dose

Age Range

18 - 101

Healthy Volunteers Needed

No

Duration of Participation

The study is divided into the following periods:
• A 28-day screening period
• A study treatment period, which may last up to 1 year
• A follow-up period which may last up to 10 weeks after last dose of study
drug
• A 2 year long-term follow-up period

Minors Included

No

Contact

Knight Cancer Institute Clinical Trials
trials@ohsu.edu
503 494-1080

Sponsor

Olema Pharmaceuticals

Recruitment End

12/30/2031

Compensation Provided

No