Overview

A Dose Escalation/Expansion Study of Oral OP-1250 in Subjects With Advanced and/or Metastatic HR+, HER2- Breast Cancer

Status:
Recruiting
Trial end date:
2023-12-01
Target enrollment:
0
Participant gender:
All
Summary
This clinical trial is a Phase 1-2, open-label, multi-center, dose-escalation and expansion study evaluating the safety, pharmacokinetics, pharmacodynamics, and antitumor activity of daily oral administration of OP-1250.
Phase:
Phase 1/Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Olema Pharmaceuticals, Inc.
Criteria
Inclusion Criteria:

- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

- Must not have received prior oral endocrine therapy > 2 weeks prior to first dose

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

- Adequate hepatic function

- Adequate renal function

- Normal coagulation panel

- Willingness to use effective contraception

Exclusion Criteria:

- Gastrointestinal disease

- Significant renal disease

- Significant cardiovascular disease

- Significant ECG abnormalities

- Ongoing systemic bacterial, fungal, or viral infection (requiring antimicrobial
therapy)

- Pregnancy or breastfeeding