Breast Cancer Clinical Trial

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

Summary

This clinical trial is a Phase 1-2, open-label, multi-center, dose-escalation and expansion study evaluating the safety, pharmacokinetics, pharmacodynamics, and antitumor activity of daily oral administration of OP-1250.

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Full Description

OP-1250 is a small molecule Complete Estrogen Receptor ANtagonist (CERAN). OP-1250 potently competes with the endogenous activating estrogenic ligand 17-beta estradiol for binding in the ligand binding pocket. OP-1250 blocks estrogen-driven transcriptional activity, inhibits estrogen-driven breast cancer cell growth, and induces degradation of the estrogen receptor.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Must not have received prior oral endocrine therapy > 2 weeks prior to first dose
Must not have received prior fulvestrant, chemotherapy, antibody therapy, or investigational therapy ≤ 4 weeks prior to the first dose
Adequate hepatic function
Adequate renal function
Normal coagulation panel
Willingness to use effective contraception

Exclusion Criteria:

Gastrointestinal disease
Significant renal disease
Significant cardiovascular disease
Significant ECG abnormalities
Ongoing systemic bacterial, fungal, or viral infection (requiring antimicrobial therapy)
Pregnancy or breastfeeding

Study is for people with:

Breast Cancer

Phase:

Phase 1

Estimated Enrollment:

94

Study ID:

NCT04505826

Recruitment Status:

Recruiting

Sponsor:

Olema Pharmaceuticals, Inc.

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There are 9 Locations for this study

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Advent Health
Orlando Florida, 32804, United States
Florida Cancer Center
Sarasota Florida, 34232, United States
OHSU Knight Cancer Institute
Portland Oregon, 97239, United States
Sarah Cannon Research Institute
Nashville Tennessee, 37203, United States
Macquarie University
Sydney New South Wales, 2109, Australia
Westmead
Westmead New South Wales, 2145, Australia
ICON Cancer Centre
Auchenflower Queensland, 4066, Australia
Cancer Research South Australia
Adelaide South Australia, 5000, Australia
Peter MacCallum Cancer Centre
Melbourne Victoria, 3000, Australia

How clear is this clinincal trial information?

Study is for people with:

Breast Cancer

Phase:

Phase 1

Estimated Enrollment:

94

Study ID:

NCT04505826

Recruitment Status:

Recruiting

Sponsor:


Olema Pharmaceuticals, Inc.

How clear is this clinincal trial information?

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