Trial Title:
Phase 1b Combo w/ Ribociclib, Alpelisib, or Everolimus
NCT ID:
NCT05508906
Condition:
Metastatic Breast Cancer
Advanced Breast Cancer
ER-positive Breast Cancer
HER2-negative Breast Cancer
Breast Cancer
Conditions: Official terms:
Breast Neoplasms
Everolimus
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Parallel Assignment
Intervention model description:
Treatment Group 1: OP-1250 in combination with ribociclib
Treatment Group 2: OP-1250 in combination with alpelisib
Treatment Group 3: OP-1250 in combination with everolimus
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
OP-1250
Description:
OP-1250 is a small molecule and a CERAN being developed for the treatment of patients
with advanced or metastatic ER+ and HER2- breast cancer.
Arm group label:
OP-1250 with Alpelisib
Arm group label:
OP-1250 with Everolimus
Arm group label:
OP-1250 with Ribociclib
Intervention type:
Drug
Intervention name:
Ribociclib
Description:
All subjects in Treatment Group 1 will receive OP-1250 in combination with ribociclib.
Arm group label:
OP-1250 with Ribociclib
Other name:
KISQALI®
Intervention type:
Drug
Intervention name:
Alpelisib
Description:
All subjects in Treatment Group 2 will receive OP-1250 in combination with alpelisib.
Arm group label:
OP-1250 with Alpelisib
Other name:
PIQRAY®
Intervention type:
Drug
Intervention name:
Everolimus
Description:
All subjects in Treatment Group 3 will receive OP-1250 in combination with everolimus.
Arm group label:
OP-1250 with Everolimus
Summary:
This is a Phase 1b open-label, 2-part study in 3 treatment groups. The 3 treatment groups
are as follows:
Treatment Group 1: OP-1250 in combination with ribociclib (KISQALI®, Novartis
Pharmaceuticals Corporation).
Treatment Group 2: OP-1250 in combination with alpelisib (PIQRAY®, Novartis
Pharmaceuticals Corporation).
Treatment Group 3: OP-1250 in combination with everolimus.
Detailed description:
Part 1 (Dose Escalation): This part will evaluate the safety and pharmacokinetics of a
range of doses of OP-1250 administered orally (PO) daily to subjects in combination with
600 mg of ribociclib administered PO daily for 21 consecutive days followed by 7 days off
treatment (Treatment Group 1) or with 300 mg or 250 mg of alpelisib administered PO daily
(Treatment Group 2) or with everolimus 10 mg administered PO daily (Treatment Group 3)
and determine the RP2D (Recommended Phase 2 Dose) for each treatment group.
Part 2 (Dose Expansion): This part of the study will further evaluate the safety and PK
of OP-1250 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 OP-1250 at an
alternate dose level in combination with ribociclib (Treatment Group 1b) will be explored
to optimize the RP2D of OP-1250.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Female or male aged >18 years.
- 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) for
advanced or metastatic disease. Prior hormonal regimens in combination with CDK4/6
inhibitors are allowed in all treatment groups.
- Has received no more than 1 prior chemotherapy (which includes antibody drug
conjugates) for locally advanced or metastatic breast cancer.
Exclusion Criteria:
- Prior or concurrent malignancy whose natural history or treatment may interfere with
the safety or efficacy assessment of the investigational regimen.
- 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.
- Has clinically significant co-morbidities, such as active infection, 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).
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Banner MD Anderson Cancer Center
Address:
City:
Gilbert
Zip:
85234
Country:
United States
Status:
Recruiting
Contact:
Last name:
Research Coordinator
Facility:
Name:
University of California San Francisco Health
Address:
City:
San Francisco
Zip:
94158
Country:
United States
Status:
Recruiting
Contact:
Last name:
Research Coordinator
Facility:
Name:
University of Colorado Cancer Center
Address:
City:
Aurora
Zip:
80045
Country:
United States
Status:
Recruiting
Contact:
Last name:
Research Coordinator
Facility:
Name:
Advent Health Hematology and Oncology
Address:
City:
Orlando
Zip:
32804
Country:
United States
Status:
Recruiting
Contact:
Last name:
Research Coordinator
Facility:
Name:
University of Iowa
Address:
City:
Iowa City
Zip:
52242
Country:
United States
Status:
Recruiting
Contact:
Last name:
Research Coordinator
Facility:
Name:
Dana Farber Cancer Institute
Address:
City:
Boston
Zip:
02215
Country:
United States
Status:
Recruiting
Contact:
Last name:
Research Coordinator
Facility:
Name:
Henry Ford Health
Address:
City:
Detroit
Zip:
48126
Country:
United States
Status:
Recruiting
Contact:
Last name:
Research Coordinator
Facility:
Name:
Regents of the University of Minnesota
Address:
City:
Minneapolis
Zip:
55455
Country:
United States
Status:
Recruiting
Contact:
Last name:
Research Coordinator
Facility:
Name:
Washington University, School of Medicine
Address:
City:
Saint Louis
Zip:
63110
Country:
United States
Status:
Recruiting
Contact:
Last name:
Research Coordinator
Facility:
Name:
Ichan School of Medicine at Mount Sinai
Address:
City:
New York
Zip:
10029
Country:
United States
Status:
Recruiting
Contact:
Last name:
Research Coordinator
Facility:
Name:
Atrium Health Levine Cancer Institute
Address:
City:
Charlotte
Zip:
28204
Country:
United States
Status:
Recruiting
Contact:
Last name:
Research Coordinator
Facility:
Name:
Henry-Joyce Cancer Clinic, The Vanderbilt Clinic
Address:
City:
Nashville
Zip:
37232
Country:
United States
Status:
Recruiting
Contact:
Last name:
Research Coordinator
Facility:
Name:
MD Anderson Cancer Center
Address:
City:
Houston
Zip:
77030
Country:
United States
Status:
Recruiting
Contact:
Last name:
Research Coordinator
Facility:
Name:
Northwest Medical Specialties
Address:
City:
Tacoma
Zip:
98405
Country:
United States
Status:
Recruiting
Contact:
Last name:
Research Coordinator
Facility:
Name:
Macquarie Health
Address:
City:
Sydney
Zip:
2109
Country:
Australia
Status:
Recruiting
Contact:
Last name:
Research Coordinator
Facility:
Name:
Breast Cancer Research Center- Western Australia
Address:
City:
Nedlands
Zip:
6009
Country:
Australia
Status:
Recruiting
Contact:
Last name:
Research Coordinator
Start date:
August 31, 2022
Completion date:
June 30, 2026
Lead sponsor:
Agency:
Olema Pharmaceuticals, Inc.
Agency class:
Industry
Collaborator:
Agency:
Novartis
Agency class:
Industry
Source:
Olema Pharmaceuticals, Inc.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05508906
