A Phase 1 Study of Oral OP-1250 in Combination With Palbociclib in HR+/HER2- Breast Cancer Patients

Study Overview
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Brief Summary
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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).

Official Title
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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

Conditions
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Breast Cancer

Intervention / Treatment
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* Drug: OP-1250
* Drug: Palbociclib


Participation Criteria
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Eligibility Criteria
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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) Pregnant

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dose Escalation<br>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 | Drug: OP-1250<br>* Complete Estrogen Receptor Antagonist<br>Drug: Palbociclib<br>* Palbociclib is an approved CDK 4/6 Inhibitor drug<br>* Other names: Ibrance®️;|
| Experimental: Dose Expansion<br>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 | Drug: OP-1250<br>* Complete Estrogen Receptor Antagonist<br>Drug: Palbociclib<br>* Palbociclib is an approved CDK 4/6 Inhibitor drug<br>* Other names: Ibrance®️;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of Dose Limiting Toxicities |  | From Cycle 1 Day 1 through C1 Day 28 | 
| 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 |