Metastatic Breast Cancer Clinical Trial
Official title:
A Phase 1b Open-Label Multicenter Study of OP-1250 in Combination With the CDK4/6 Inhibitor Ribociclib or With the PI3K Inhibitor Alpelisib in Adult Subjects With Advanced and/or Metastatic HR Positive, HER2 Negative Breast Cancer
This is a Phase 1b open-label, 2-part study in 2 treatment groups. The 2 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).
Status | Recruiting |
Enrollment | 90 |
Est. completion date | August 31, 2024 |
Est. primary completion date | August 31, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 MBC - HR+/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 (measurable and non-measurable): 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).-Subject must have received at least 6 months of a prior continuous endocrine therapy for locally advanced or metastatic breast cancer - 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) for advanced or metastatic disease. Prior hormonal regimens in combination with CDK4/6 inhibitors are allowed. - 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 |
Country | Name | City | State |
---|---|---|---|
Australia | Breast Cancer Research Center- Western Australia | Nedlands | Western Australia |
Australia | Macquarie Health | New South Wales | |
United States | University of Colorado Cancer Center | Aurora | Colorado |
United States | Dana Farber Cancer Institute | Boston | Massachusetts |
United States | Atrium Health Levine Cancer Institute | Charlotte | North Carolina |
United States | Henry Ford Health | Detroit | Michigan |
United States | Banner MD Anderson Cancer Center | Gilbert | Arizona |
United States | MD Anderson Cancer Center | Houston | Texas |
United States | University of Iowa | Iowa City | Iowa |
United States | Regents of the University of Minnesota | Minneapolis | Minnesota |
United States | Henry-Joyce Cancer Clinic, The Vanderbilt Clinic | Nashville | Tennessee |
United States | Ichan School of Medicine at Mount Sinai | New York | New York |
United States | Advent Health Hematology and Oncology | Orlando | Florida |
United States | Washington University, School of Medicine | Saint Louis | Missouri |
United States | University of California San Francisco Health | San Francisco | California |
United States | Northwest Medical Specialties | Tacoma | Washington |
Lead Sponsor | Collaborator |
---|---|
Olema Pharmaceuticals, Inc. | Novartis |
United States, Australia,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Dose Limiting Toxicities (DLTs) | To determine the maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D) of OP-1250 when administered with ribociclib (Treatment Group 1) or alpelisib (Treatment Group 2), the incidence of DLTs will be assessed in the Dose Escalation part (Part 1) of the study. | The first 28 days of treatment | |
Primary | Characterize the incidence, nature and severity of treatment emergent adverse events (TEAEs) and serious adverse events (SAEs) of OP-1250 when administered with ribociclib (Treatment Group 1) or alpelisib (Treatment Group 2) | Characterize the incidence, nature and severity of TEAEs and SAEs of OP-1250 when administered with ribociclib (Treatment Group 1) or alpelisib (Treatment Group 2) according to NCI-CTCAE version 5.0. | Up to 35 days after end of treatment | |
Primary | Pharmacokinetics (PK) of OP-1250 when administered with ribociclib (Treatment Group 1) or alpelisib (Treatment Group 2) | To assess the PK of OP-1250 in combination with ribociclib or alpelisib, plasma levels of OP-1250 (and potential metabolites) and ribociclib (Treatment Group 1) and plasma levels of OP-1250 (and potential metabolites) and alpelisib (Treatment Group 2) will be assessed at predefined intervals. | Every 28 days | |
Secondary | Preliminarily assess the anti-tumor activity of OP-1250 when administered with ribociclib (Treatment Group 1) or alpelisib (Treatment Group 2) | Tumor response will be evaluated in patients with measurable or evaluable disease using RECISTv1.1 guidelines. | Up to 1 year | |
Secondary | Evaluate clinical benefit rate (CBR) of OP-1250 when administered with ribociclib (Treatment Group 1) or alpelisib (Treatment Group 2) | CBR will be assessed as proportion of subjects achieving complete response (CR), partial response (PR), or stable disease (SD) with duration of at least 24 weeks. | Up to 1 year | |
Secondary | Evaluate duration of response (DOR) of OP-1250 when administered with ribociclib (Treatment Group 1) or alpelisib (Treatment Group 2) | DOR will be calculated as the number of days from the start date of PR or CR (whichever response is achieved first) to the first date that progressive disease is documented. | Up to 1 year |
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