Status:
ACTIVE_NOT_RECRUITING
A Phase 1 Study of Oral OP-1250 in Combination With Palbociclib in HR+/HER2- Breast Cancer Patients
Lead Sponsor:
Olema Pharmaceuticals, Inc.
Collaborating Sponsors:
Pfizer
Conditions:
Breast Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief 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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 10 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2026
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT05266105
Start Date
December 10 2021
End Date
March 1 2026
Last Update
November 24 2025
Active Locations (8)
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1
Clinical Trial Site
Waratah, New South Wales, Australia, 2298
2
Clinical Trial Site
Westmead, New South Wales, Australia, 2145
3
Clinical Trial Site
South Brisbane, Queensland, Australia, 4101
4
Clinical Trial Site
Southport, Queensland, Australia, 4215