A Dose Escalation/Expansion Study of Oral OP-1250 in Subjects With Advanced and/or Metastatic HR+, HER2- Breast Cancer
NCT ID: NCT04505826
Last Updated: 2025-08-24
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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COMPLETED
PHASE1/PHASE2
153 participants
INTERVENTIONAL
2020-08-13
2024-07-30
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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OP-1250 Phase I Part A (Dose Escalation) and Part B (Dose Expansion)
Phase I Part A will evaluate the safety and pharmacokinetics (PK)of a range of OP-1250 doses to identify the maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D). Phase I Part B will evaluate the safety and PK of OP-1250 to confirm the RP2D dose.
OP-1250
Complete Estrogen Receptor ANtagonist (CERAN)
OP-1250 Phase II
This portion of the study further explores the clinical activity, safety, and PK of OP-1250 monotherapy at the RP2D and will estimate preliminary anti-tumor efficacy in 3 cohorts.
Cohort A will enroll subjects with measurable disease without evidence of CNS metastases; Cohort B will enroll subjects with non-measurable (evaluable) disease without evidence of CNS metastases; and Cohort C will enroll subjects with evaluable disease (measurable and non-measurable) with CNS metastases.
OP-1250
Complete Estrogen Receptor ANtagonist (CERAN)
Interventions
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OP-1250
Complete Estrogen Receptor ANtagonist (CERAN)
Eligibility Criteria
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Inclusion Criteria
* Must have received at least 1 prior hormonal regimen and at least 6 months of a prior continuous endocrine therapy for locally advanced or metastatic disease
* Must not have received prior oral endocrine therapy \< 2 weeks prior to first dose
* Must not have received prior, chemotherapy in 2 weeks or within 5 half-lives whichever is earlier, antibody therapy within 4 weeks or investigational therapy within 4 weeks or 5 half-lives whichever is earlier, prior to the first dose
* Adequate hepatic function
* Adequate renal function
* Normal coagulation panel
* Willingness to use effective contraception
Exclusion Criteria
* Significant renal disease
* Significant cardiovascular disease
* Significant ECG abnormalities
* Ongoing systemic bacterial, fungal, or viral infection (requiring antimicrobial therapy)
* Pregnancy or breastfeeding
18 Years
ALL
No
Sponsors
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Olema Pharmaceuticals, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Mark Shilkrut, MD
Role: STUDY_DIRECTOR
Olema Pharmaceuticals, Inc.
Locations
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UCLA Hematology/Oncology
Los Angeles, California, United States
University of Colorado
Aurora, Colorado, United States
University of Miami, Sylvester Comprehensive Cancer Center
Deerfield Beach, Florida, United States
Advent Health
Orlando, Florida, United States
Florida Cancer Center
Sarasota, Florida, United States
Winship Cancer Institute of Emory University
Atlanta, Georgia, United States
Indiana University Melvin and Bren Simon Comprehensive Cancer Center
Indianapolis, Indiana, United States
Dana Farber Cancer Institute
Boston, Massachusetts, United States
Saint Luke's Hospital of Kansas City
Kansas City, Missouri, United States
Montefiore Medical Center
The Bronx, New York, United States
Cleveland Clinic Taussig Cancer Center
Cleveland, Ohio, United States
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, United States
Providence Portland Medical Center
Portland, Oregon, United States
OHSU Knight Cancer Institute
Portland, Oregon, United States
Sarah Cannon Research Institute
Nashville, Tennessee, United States
Macquarie University
Sydney, New South Wales, Australia
Westmead
Westmead, New South Wales, Australia
ICON Cancer Centre
Auchenflower, Queensland, Australia
Cancer Research South Australia
Adelaide, South Australia, Australia
Countries
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References
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Hamilton EP, Patel MR, Borges VF, Meisel JL, Okera M, Alemany CA, Pluard TJ, Wesolowski R, Sabanathan D, Miller KD, Conlin AK, McCarthy N, Shaw M, Tonda M, Shilkrut M, Lin NU. Palazestrant, a novel oral Complete Estrogen Receptor Antagonist (CERAN) and Selective Estrogen Receptor Degrader (SERD), in patients with ER+/HER2- advanced or metastatic breast cancer: phase 1/2 study results. Breast Cancer Res. 2025 Jul 1;27(1):119. doi: 10.1186/s13058-025-02049-y.
Other Identifiers
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OP-1250-001
Identifier Type: -
Identifier Source: org_study_id
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