A Dose Escalation/Expansion Study of Oral OP-1250 in Subjects With Advanced and/or Metastatic HR+, HER2- Breast Cancer

Active:	No
Cancer Type:	Breast Cancer Unknown Primary	NCT ID:	NCT04505826
Trial Phases:	Phase I Phase II	Protocol IDs:	OP-1250-001 (primary) NCI-2020-13877
Eligibility:	18 Years and older, Male and Female	Study Type:	Treatment
Study Sponsor:	Olema Pharmaceuticals, Inc.
NCI Full Details:	http://clinicaltrials.gov/show/NCT04505826

Summary

This clinical trial is a Phase I dose escalation and dose expansion and Phase II
monotherapy open-label, first-in-human, multicenter study of OP-1250 in adult subjects
with advanced and/or metastatic hormone receptor (HR)-positive, her2-negative breast
cancer.

Objectives

This is a Phase I dose escalation and dose expansion and Phase II monotherapy
open--label, first--in--human study to determine the dose limiting toxicity (DLT),
maximum tolerated dose (MTD) and/or recommended Phase II dose (RP2D), to characterize the
safety and pharmacokinetic (PK) profile, and to estimate the preliminary anti-tumor
activity of OP-1250 as a single agent in adult subjects with hormone receptor
(HR)-positive/human epidermal growth factor receptor 2 (HER2)-negative metastatic or
locally advanced breast cancer. This study comprises 2 Phases: Phase I (Part A [Dose
Escalation] and Part B [Dose Expansion]) and Phase II. Additionally, all subjects (Phase
I and Phase II) will be eligible to participate in 1 of 2 sub-studies. Patients must have
received at least 1 prior hormonal regimen and at least 6 months of a prior continuous
endocrine therapy for locally advanced or metastatic disease. Patients will be evaluated
for treatment emergent adverse events (AEs) during study participation, and toxicity will
be assessed according to the National Cancer Institute (NCI) Common Terminology Criteria
for Adverse Events, Version 5.0.

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