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