Palbociclib: Palbociclib is an approved CDK 4/6 Inhibitor drug
Study 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).
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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
Primary outcome measure(s)
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
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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