A Phase 1 Study of Oral OP-1250 in Combination With Palbociclib in HR+/HER2- Breast Cancer Patients

• Status: Recruiting
• Trial end date: 2023-12-01
• Target enrollment: 0
• Participant gender: All

Summary

This is an open-label, Phase 1b dose escalation and expansion study to determine the maximum tolerated dose (MTD) of OP-1250 in combination with palbociclib (Ibrance®️, Pfizer Inc.). Purpose of study is to evaluate the safety and pharmacokinetic (PK) profile, and estimate the preliminary anti-tumor activity of the combination in adult subjects with hormone receptor-positive (ER+ / HER2-) advanced or metastatic breast cancer (MBC).

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Olema Pharmaceuticals, Inc.
• Collaborator: Pfizer
• Treatments: Palbociclib

Criteria

Inclusion Criteria:

• Confirmed and evaluable locally advanced or metastatic breast cancer

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

• Must not have received prior oral endocrine or targeted therapy ≤ 2 weeks prior to first dose

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

• Prior radiotherapy must have been completed 2 weeks prior to first dose

• Adequate safety laboratory tests

• Willingness to use effective contraception

Exclusion Criteria:

• Gastrointestinal disease

• Significant hepatic disease

• Significant cardiovascular disease

• Significant ECG abnormalities

• History of pulmonary embolism or high risk of thrombosis

• Known HIV infection

• Active infection (requiring antimicrobial therapy)

• Pregnant