A Phase 1 Dose Escalation and Expansion Open-label, Multicenter, Study of OP-1250 in Combination With the CDK4/6 Inhibitor Palbociclib in Adult Subjects With Advanced or Metastatic HR-positive, HER2-negative Breast Cancer
Overview
- Phase
- Phase 1
- Intervention
- Palazestrant
- Conditions
- Breast Cancer
- Sponsor
- Olema Pharmaceuticals, Inc.
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Characterization and Incidence in Adverse Events and Serious Adverse Events
- Status
- Active, not recruiting
- Last Updated
- 5 months ago
Overview
Brief Summary
This is an open-label, Phase 1b dose escalation and expansion study to determine the maximum tolerated dose (MTD) of OP-1250 in combination with palbociclib (Ibrance®️, Pfizer Inc.). Purpose of study is to evaluate the safety and pharmacokinetic (PK) profile, and estimate the preliminary anti-tumor activity of the combination in adult subjects with hormone receptor-positive (ER+ / HER2-) advanced or metastatic breast cancer (MBC).
Investigators
Eligibility Criteria
Inclusion Criteria
- •Confirmed and evaluable locally advanced or metastatic breast cancer
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- •Must not have received prior oral endocrine or targeted therapy ≤ 2 weeks prior to first dose
- •Must not have received prior chemotherapy, antibody therapy, or investigational therapy ≤ 4 weeks prior to the first dose
- •Prior radiotherapy must have been completed 2 weeks prior to first dose
- •Adequate safety laboratory tests
- •Willingness to use effective contraception
Exclusion Criteria
- •Gastrointestinal disease
- •Significant hepatic disease
- •Significant cardiovascular disease
- •Significant ECG abnormalities
- •History of pulmonary embolism or high risk of thrombosis
- •Known HIV infection
- •Active infection (requiring antimicrobial therapy)
Arms & Interventions
Dose Escalation
This portion of the study will evaluate the safety and pharmacology of a range of OP-1250 doses administered daily with Palbociclib in subjects with advanced and/or metastatic hormone receptor (HR)-positive, HER2-negative breast cancer
Intervention: Palazestrant
Dose Escalation
This portion of the study will evaluate the safety and pharmacology of a range of OP-1250 doses administered daily with Palbociclib in subjects with advanced and/or metastatic hormone receptor (HR)-positive, HER2-negative breast cancer
Intervention: Palbociclib
Dose Expansion
This portion of the study further explores the clinical activity, safety and pharmacology of OP-1250 in combination with Palbociclib and estimates preliminary data of anti-tumor efficacy
Intervention: Palazestrant
Dose Expansion
This portion of the study further explores the clinical activity, safety and pharmacology of OP-1250 in combination with Palbociclib and estimates preliminary data of anti-tumor efficacy
Intervention: Palbociclib
Outcomes
Primary Outcomes
Characterization and Incidence in Adverse Events and Serious Adverse Events
Time Frame: From initial inform consent date through 30 days post last dose
Plasma levels of OP-1250 and Palbociclib
Time Frame: Up to 9 months
Incidence of Dose Limiting Toxicities
Time Frame: From Cycle 1 Day 1 through C1 Day 28