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

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ClinicalTrials.gov Identifier: NCT04505826
Recruitment Status : Recruiting
First Posted : August 10, 2020
Last Update Posted : October 25, 2021
Information provided by (Responsible Party):
Olema Pharmaceuticals, Inc.

Brief 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.

Condition or disease Intervention/treatment Phase
Hormone Receptor Positive Breast Carcinoma HER2-negative Breast Cancer Drug: OP-1250 Phase 1 Phase 2

Detailed 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 94 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I/II Open-label, First-in-Human, Multicenter, Dose Escalation and Dose Expansion Study of OP-1250 Monotherapy in Adult Subjects With Advanced and/or Metastatic Hormone Receptor (HR)-Positive, HER2-negative Breast Cancer
Actual Study Start Date : August 13, 2020
Estimated Primary Completion Date : October 2023
Estimated Study Completion Date : December 2023

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: OP-1250 Dose Escalation
This portion of the study will evaluate the safety and pharmacology of a range of OP-1250 doses administered daily in subjects with advanced and/or metastatic hormone receptor (HR)-positive, HER2-negative breast cancer and to determine the RP2D
Drug: OP-1250
Complete Estrogen Receptor ANtagonist (CERAN)

Experimental: OP-1250 Expansion
This portion of the study further explores the clinical activity, safety and pharmacology of OP-1250 monotherapy at the RP2D and to estimate preliminary data of anti-tumor efficacy
Drug: OP-1250
Complete Estrogen Receptor ANtagonist (CERAN)

Primary Outcome Measures :
  1. Determine MTD and/or RP2D of OP-1250 when used as a single agent [ Time Frame: Up to one year ]
    Number of patients with DLT as defined in the protocol

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04505826

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Contact: There may be multiple sites in this clinical trial. (415) 651-7206 clinical@olemapharma.com

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United States, Florida
Advent Health Recruiting
Orlando, Florida, United States, 32804
Florida Cancer Center Recruiting
Sarasota, Florida, United States, 34232
United States, Oregon
OHSU Knight Cancer Institute Recruiting
Portland, Oregon, United States, 97239
United States, Tennessee
Sarah Cannon Research Institute Recruiting
Nashville, Tennessee, United States, 37203
Australia, New South Wales
Macquarie University Recruiting
Sydney, New South Wales, Australia, 2109
Westmead Not yet recruiting
Westmead, New South Wales, Australia, 2145
Australia, Queensland
ICON Cancer Centre Not yet recruiting
Auchenflower, Queensland, Australia, 4066
Australia, South Australia
Cancer Research South Australia Not yet recruiting
Adelaide, South Australia, Australia, 5000
Australia, Victoria
Peter MacCallum Cancer Centre Not yet recruiting
Melbourne, Victoria, Australia, 3000
Sponsors and Collaborators
Olema Pharmaceuticals, Inc.
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Study Director: Jo Anne Zujewski, MD Olema Pharmaceuticals, Inc.
Study Director: Trinh Le Olema Pharmaceuticals, Inc.
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Responsible Party: Olema Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT04505826    
Other Study ID Numbers: OP-1250-001
First Posted: August 10, 2020    Key Record Dates
Last Update Posted: October 25, 2021
Last Verified: October 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases