Phase 1b Study of OP-1250 (Palazestrant) in Combination With Ribociclib, Alpelisib, Everolimus, or Atirmociclib in ER+, HER2- Breast Cancer
NCT ID: NCT05508906
Last Updated: 2025-10-22
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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RECRUITING
PHASE1
190 participants
INTERVENTIONAL
2022-08-31
2028-01-31
Brief Summary
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Treatment Group 1: Palazestrant (OP-1250) in combination with ribociclib (KISQALI®, Novartis Pharmaceuticals Corporation).
Treatment Group 2: Palazestrant (OP-1250) in combination with alpelisib (PIQRAY®, Novartis Pharmaceuticals Corporation).
Treatment Group 3: Palazestrant (OP-1250) in combination with everolimus.
Treatment Group 4: Palazestrant (OP-1250) in combination with atirmociclib.
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Detailed Description
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Part 2 (Dose Expansion): This part of the study will further evaluate the safety and PK of palazestrant at the RP2D in combination with ribociclib (Treatment Group 1), alpelisib (Treatment Group 2), or everolimus (Treatment Group 3) and provide an exploratory estimate of anti-tumor activity of the combinations. An additional group of palazestrant at an alternate dose level in combination with ribociclib (Treatment Group 1b) will be explored to optimize the RP2D of palazestrant. Part 2, for Treatment Group 4, will further evaluate the safety and pharmacokinetics of atirmociclib and OP-1250 at the recommended dose for expansion.
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
Treatment Group 2: Palazestrant in combination with alpelisib
Treatment Group 3: Palazestrant in combination with everolimus
Treatment Group 4: Palazestrant in combination with atirmociclib
TREATMENT
NONE
Study Groups
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Palazestrant with Ribociclib
Treatment Group 1: Palazestrant in combination with ribociclib (KISQALI®, Novartis Pharmaceuticals Corporation).
Palazestrant
Complete estrogen receptor antagonist (CERAN)
Ribociclib
All subjects in Treatment Group 1 will receive palazestrant in combination with ribociclib.
Palazestrant with Alpelisib
Treatment Group 2: Palazestrant in combination with alpelisib (PIQRAY®, Novartis Pharmaceuticals Corporation)
Palazestrant
Complete estrogen receptor antagonist (CERAN)
Alpelisib
All subjects in Treatment Group 2 will receive palazestrant in combination with alpelisib.
Palazestrant with Everolimus
Treatment Group 3: Palazestrant in combination with everolimus
Palazestrant
Complete estrogen receptor antagonist (CERAN)
Everolimus
All subjects in Treatment Group 3 will receive palazestrant in combination with everolimus.
Palazestrant with Atirmociclib
Treatment Group 4: Palazestrant in combination with atirmociclib
Palazestrant
Complete estrogen receptor antagonist (CERAN)
Atirmociclib
All subjects in Treatment Group 4 will receive palazestrant in combination with atirmociclib.
Interventions
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Palazestrant
Complete estrogen receptor antagonist (CERAN)
Ribociclib
All subjects in Treatment Group 1 will receive palazestrant in combination with ribociclib.
Alpelisib
All subjects in Treatment Group 2 will receive palazestrant in combination with alpelisib.
Everolimus
All subjects in Treatment Group 3 will receive palazestrant in combination with everolimus.
Atirmociclib
All subjects in Treatment Group 4 will receive palazestrant in combination with atirmociclib.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Willing and able to participate and comply with all study requirements.
* Histologically- or cytologically-confirmed advanced or metastatic Breast Cancer (mBC).
* ER+/HER2- disease, as determined in the most recently obtained archival tumor tissue sample from a metastatic site, using locally accepted criteria by the local pathology report.
* Evaluable disease with one of the following: Measurable disease, ie, at least 1 measurable lesion as per RECIST 1.1 (a lesion at a previously irradiated site may only be counted as a target lesion if there is clear sign of progression since the irradiation) OR patients with predominantly bone disease (with or without other non-measurable lesions) are allowed if it is possible to evaluate on radiological examinations (eg. bone scan, PET/CT, CT, MRI) even if lesions are non-measurable according to RECIST 1.1.
* Life expectancy ≥6 months, as judged by the investigator.
* Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1.
* Has received no more than 1 prior hormonal regimen (Treatment Group 1). Has received no more than 2 prior hormonal regimens (Treatment Group 2 and Treatment Group 3) . Has received no more than 2 prior hormonal regimens for metastatic disease in Part 1 (Dose Escalation) and no more than 1 prior hormonal regimes in Part 2 (Dose Expansion) for metastatic disease, regardless of type of endocrine agent (Treatment Group 4) for advanced or metastatic disease. Prior hormonal regimens in combination with CDK4/6 inhibitors are allowed in all treatment groups. For subjects in Treatment Group 4, no prior chemotherapy for metastatic breast cancer is allowed.
* Has received no more than 1 prior chemotherapy (which includes antibody drug conjugates) for locally advanced or metastatic breast cancer.
Exclusion Criteria
* Clinically significant, uncontrolled heart disease and/or cardiac repolarization abnormality.
* History of cerebral vascular disease within 6 months prior to the first administration of study drug dose.
* History of a pulmonary embolism, or deep venous thrombosis within the last 6 months, or subject has an increased risk of thrombosis as determined by the investigator.
* History of pneumonitis or interstitial lung disease.
* Leptomeningeal disease or spinal cord compression.
* Medical history or ongoing gastrointestinal disorders that could affect absorption of oral therapeutics.
* Known human immunodeficiency virus infection.
* Known clinically significant history of liver disease consistent with Child-Pugh Class B or C, including active viral or other hepatitis (eg, hepatitis B or hepatitis C virus), current alcohol abuse, or cirrhosis.
* History of severe cutaneous reaction, such as Stevens-Johnson syndrome, erythema multiforme, toxic epidermal necrolysis, or drug reaction with eosinophilia and systemic symptoms.
* Active infection or at a high risk of developing a serious infection (e.g. participants with immunodeficiencies, uncontrolled diabetes mellitus, uncontrolled heart disease, poor general health, poor nutritional status).
* Has clinically significant co-morbidities, such as, psychiatric disease, or any other condition that could impact the ability of the subject to participate in this study or otherwise has the potential to confound the study results.
* Have received prior treatment with OP-1250.
* Have received prior treatment with approved or investigational PI3K inhibitor (Treatment Group 2) or mTOR inhibitor (Treatment Group 3).
18 Years
ALL
No
Sponsors
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Novartis
INDUSTRY
Pfizer
INDUSTRY
Olema Pharmaceuticals, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Daniela Vecchio, PhD
Role: STUDY_DIRECTOR
Olema Pharmaceuticals, Inc.
Locations
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Banner MD Anderson Cancer Center
Gilbert, Arizona, United States
University of California San Francisco Health
San Francisco, California, United States
University of Colorado Cancer Center
Aurora, Colorado, United States
Advent Health Hematology and Oncology
Orlando, Florida, United States
University of Iowa
Iowa City, Iowa, United States
Dana Farber Cancer Institute
Boston, Massachusetts, United States
Henry Ford Health
Detroit, Michigan, United States
Regents of the University of Minnesota
Minneapolis, Minnesota, United States
Washington University, School of Medicine
St Louis, Missouri, United States
Ichan School of Medicine at Mount Sinai
New York, New York, United States
Atrium Health Levine Cancer Institute
Charlotte, North Carolina, United States
Henry-Joyce Cancer Clinic, The Vanderbilt Clinic
Nashville, Tennessee, United States
MD Anderson Cancer Center
Houston, Texas, United States
Northwest Medical Specialties
Tacoma, Washington, United States
Macquarie Health
Sydney, New South Wales, Australia
Breast Cancer Research Center- Western Australia
Nedlands, Western Australia, Australia
Countries
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Central Contacts
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Facility Contacts
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Research Coordinator
Role: primary
Research Coordinator
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Research Coordinator
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Research Coordinator
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Research Coordinator
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Research Coordinator
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Research Coordinator
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Research Coordinator
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Research Coordinator
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Research Coordinator
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Research Coordinator
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Research Coordinator
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Research Coordinator
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Research Coordinator
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Research Coordinator
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Research Coordinator
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Other Identifiers
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OP-1250-003
Identifier Type: -
Identifier Source: org_study_id
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