Clinical Trials /

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

NCT04505826

Description:

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.

Related Conditions:
  • Breast Carcinoma
Recruiting Status:

Recruiting

Phase:

Phase 1/Phase 2

URL:

https://clinicaltrials.gov/show/NCT04505826

Trial Eligibility

Document

Title

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

Clinical Trial IDs

  • ORG STUDY ID: OP-1250-001
  • NCT ID: NCT04505826

Conditions

  • Hormone Receptor Positive Breast Carcinoma
  • HER2-negative Breast Cancer

Interventions

DrugSynonymsArms
OP-1250OP-1250 Dose Escalation

Purpose

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.

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.

Trial Arms

NameTypeDescriptionInterventions
OP-1250 Dose EscalationExperimentalThis 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
  • OP-1250
OP-1250 ExpansionExperimentalThis 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
  • OP-1250

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
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Determine MTD and/or RP2D of OP-1250 when used as a single agent
Time Frame:Up to one year
Safety Issue:
Description:Number of patients with DLT as defined in the protocol

Details

Phase:Phase 1/Phase 2
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Olema Pharmaceuticals, Inc.

Last Updated

May 5, 2021