Actively Recruiting
Phase 1b Study of OP-1250 (Palazestrant) in Combination With Ribociclib, Alpelisib, Everolimus, or Atirmociclib in ER+, HER2- Breast Cancer
Led by Olema Pharmaceuticals, Inc. · Updated on 2025-10-22
190
Participants Needed
16
Research Sites
282 weeks
Total Duration
On this page
Sponsors
O
Olema Pharmaceuticals, Inc.
Lead Sponsor
N
Novartis
Collaborating Sponsor
AI-Summary
What this Trial Is About
This is a Phase 1b open-label, 2-part study in 3 treatment groups. The 3 treatment groups are as follows: 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.
CONDITIONS
Official Title
Phase 1b Study of OP-1250 (Palazestrant) in Combination With Ribociclib, Alpelisib, Everolimus, or Atirmociclib in ER+, HER2- Breast Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female or male aged >18 years
- Willing and able to participate and follow all study requirements
- Histologically or cytologically confirmed advanced or metastatic breast cancer
- ER-positive and HER2-negative breast cancer confirmed from recent metastatic tumor tissue
- Measurable disease by RECIST 1.1 or evaluable bone disease on imaging
- Life expectancy of at least 6 months
- ECOG performance status of 0 or 1
- No more than 1 prior hormonal regimen for Treatment Group 1
- No more than 2 prior hormonal regimens for Treatment Groups 2 and 3
- No more than 2 prior hormonal regimens in Part 1 and no more than 1 in Part 2 for Treatment Group 4
- Prior hormonal regimens with CDK4/6 inhibitors allowed
- For Treatment Group 4, no prior chemotherapy for metastatic breast cancer allowed
- No more than 1 prior chemotherapy for locally advanced or metastatic breast cancer, including antibody drug conjugates
You will not qualify if you...
- Prior or concurrent malignancy that may interfere with safety or efficacy assessment
- Clinically significant uncontrolled heart disease or cardiac repolarization abnormality
- History of stroke within 6 months before study drug administration
- History of pulmonary embolism or deep venous thrombosis within 6 months or high risk of thrombosis
- History of pneumonitis or interstitial lung disease
- Leptomeningeal disease or spinal cord compression
- Gastrointestinal disorders affecting oral drug absorption
- Known HIV infection
- Clinically significant liver disease (Child-Pugh Class B or C), active viral hepatitis, alcohol abuse, or cirrhosis
- History of severe skin reactions like Stevens-Johnson syndrome or toxic epidermal necrolysis
- Active infection or high risk of serious infection
- Significant psychiatric disease or other conditions impacting study participation
- Prior treatment with OP-1250
- Prior treatment with approved or investigational PI3K inhibitors (Treatment Group 2) or mTOR inhibitors (Treatment Group 3)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 16 locations
1
Banner MD Anderson Cancer Center
Gilbert, Arizona, United States, 85234
Actively Recruiting
2
University of California San Francisco Health
San Francisco, California, United States, 94158
Actively Recruiting
3
University of Colorado Cancer Center
Aurora, Colorado, United States, 80045
Actively Recruiting
4
Advent Health Hematology and Oncology
Orlando, Florida, United States, 32804
Actively Recruiting
5
University of Iowa
Iowa City, Iowa, United States, 52242
Actively Recruiting
6
Dana Farber Cancer Institute
Boston, Massachusetts, United States, 02215
Actively Recruiting
7
Henry Ford Health
Detroit, Michigan, United States, 48126
Actively Recruiting
8
Regents of the University of Minnesota
Minneapolis, Minnesota, United States, 55455
Actively Recruiting
9
Washington University, School of Medicine
St Louis, Missouri, United States, 63110
Actively Recruiting
10
Ichan School of Medicine at Mount Sinai
New York, New York, United States, 10029
Actively Recruiting
11
Atrium Health Levine Cancer Institute
Charlotte, North Carolina, United States, 28204
Actively Recruiting
12
Henry-Joyce Cancer Clinic, The Vanderbilt Clinic
Nashville, Tennessee, United States, 37232
Actively Recruiting
13
MD Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
14
Northwest Medical Specialties
Tacoma, Washington, United States, 98405
Actively Recruiting
15
Macquarie Health
Sydney, New South Wales, Australia, 2109
Actively Recruiting
16
Breast Cancer Research Center- Western Australia
Nedlands, Western Australia, Australia, 6009
Actively Recruiting
Research Team
O
OP-1250-003 Study
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
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