A Phase 1 Study of Oral OP-1250 in Combination With Palbociclib in HR+/HER2- Breast Cancer Patients
NCT ID: NCT05266105
Last Updated: 2025-11-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE1
60 participants
INTERVENTIONAL
2021-12-10
2026-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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Dose Escalation
This portion of the study will evaluate the safety and pharmacology of a range of OP-1250 doses administered daily with Palbociclib in subjects with advanced and/or metastatic hormone receptor (HR)-positive, HER2-negative breast cancer
Palazestrant
Complete Estrogen Receptor Antagonist
Palbociclib
Palbociclib is an approved CDK 4/6 Inhibitor drug
Dose Expansion
This portion of the study further explores the clinical activity, safety and pharmacology of OP-1250 in combination with Palbociclib and estimates preliminary data of anti-tumor efficacy
Palazestrant
Complete Estrogen Receptor Antagonist
Palbociclib
Palbociclib is an approved CDK 4/6 Inhibitor drug
Interventions
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Palazestrant
Complete Estrogen Receptor Antagonist
Palbociclib
Palbociclib is an approved CDK 4/6 Inhibitor drug
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Pfizer
INDUSTRY
Olema Pharmaceuticals, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Sue Johnson
Role: STUDY_DIRECTOR
Olema Pharmaceuticals, Inc.
Locations
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Clinical Trial Site
Waratah, New South Wales, Australia
Clinical Trial Site
Westmead, New South Wales, Australia
Clinical Trial Site
South Brisbane, Queensland, Australia
Clinical Trial Site
Southport, Queensland, Australia
Clinical Trial Site
Clayton, Victoria, Australia
Clinical Trial Site
Frankston, Victoria, Australia
Clinical Trial Site
Geelong, Victoria, Australia
Clinical Trial Site
Nedlands, Western Australia, Australia
Countries
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Other Identifiers
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OP-1250-002
Identifier Type: -
Identifier Source: org_study_id
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