A Dose Escalation/Expansion Study of Oral OP-1250 in Subjects With Advanced and/or Metastatic HR+, HER2- Breast Cancer
Breast Cancer
Unknown Primary
18 Years and older, Male and Female
OP-1250-001 (primary)
NCI-2020-13877
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.
Eligibility
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- 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
- Must not have received prior oral endocrine therapy < 2 weeks prior to first dose
- Must not have received prior, chemotherapy in 2 weeks or within 5 half-lives whichever is earlier, antibody therapy within 4 weeks or investigational therapy within 4 weeks or 5 half-lives whichever is earlier, prior to the first dose
- Adequate hepatic function
- Adequate renal function
- Normal coagulation panel
- Willingness to use effective contraception
**Clinical trials are research studies that involve people. These studies test new ways to prevent, detect, diagnose, or treat diseases. People who take part in cancer clinical trials have an opportunity to contribute to scientists’ knowledge about cancer and to help in the development of improved cancer treatments. They also receive state-of-the-art care from cancer experts...
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