MedTrace Logo

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

NCT04505826 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 153

Last updated 2026-05-11

Study results available
· View outcomes & findings →

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.

Conditions

Interventions

DRUG

OP-1250

Complete Estrogen Receptor ANtagonist (CERAN)

Sponsors & Collaborators

  • Olema Pharmaceuticals, Inc.

    lead INDUSTRY

Principal Investigators

  • Margaret Tonda · Olema Pharmaceuticals, Inc.

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-08-13
Primary Completion
2024-07-30
Completion
2024-07-30
FDA Drug
Yes

Countries

  • United States
  • Australia

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04505826 on ClinicalTrials.gov