A Phase 1 Study of Oral OP-1250 in Combination With Palbociclib in HR+/HER2- Breast Cancer Patients
- Conditions
- Breast Cancer
- Interventions
- Drug: PalazestrantDrug: Palbociclib
- Registration Number
- NCT05266105
- Lead Sponsor
- Olema Pharmaceuticals, Inc.
- 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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 60
- 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
- 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)
- Pregnant
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Dose Escalation Palazestrant 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 Dose Expansion Palazestrant 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 Dose Escalation Palbociclib 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 Dose Expansion Palbociclib 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
- Primary Outcome Measures
Name Time Method Characterization and Incidence in Adverse Events and Serious Adverse Events From initial inform consent date through 30 days post last dose Plasma levels of OP-1250 and Palbociclib Up to 9 months Incidence of Dose Limiting Toxicities From Cycle 1 Day 1 through C1 Day 28
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (8)
Site 6101
🇦🇺Clayton, Victoria, Australia
Site 6102
🇦🇺South Brisbane, Queensland, Australia
Site 6109
🇦🇺Southport, Queensland, Australia
Site 6104
🇦🇺Westmead, New South Wales, Australia
Site 6108
🇦🇺Waratah, New South Wales, Australia
Site 6105
🇦🇺Nedlands, Western Australia, Australia
Site 6106
🇦🇺Frankston, Victoria, Australia
Site 6103
🇦🇺Geelong, Victoria, Australia