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RecruitingLast updated: 3 April 2024

Olema: This Phase I trial is seeking to determine the recommended dose, safety and tolerability of a new hormone therapy (OP-1250) in combination with targeted therapy (palbociclib) in people with advanced or metastatic HR+ and HER2- breast cancerA Phase 1 Dose Escalation and Dose Expansion Open-label, Multicenter, Study of OP-1250 in Combination with the CDK4/6 Inhibitor Palbociclib in Adult Subjects with Advanced or Metastatic HR-positive, HER2-negative Breast Cancer

Clinical summary

Summary

This study consists of two parts: Part 1 Dose Escalation, and Part 2 Dose Expansion. In Part 1, participants will be allocated to receive different dosage levels of OP-1250 and this will be administered (orally) once daily in continuous 28-day cycles, in combination with oral palbociclib (125mg) once daily for 21 days in continuous 28-day cycles. Participants will continue to receive treatment at the assigned dose level, or at a reduced dose if required based on any toxicities that occur. Part 2 further explores the safety and Pharmacokinetics of OP-1250 in combination with Palbociclib and to determine the recommended Phase II dose (RP2D) of OP-1250.

Conditions

This trial is treating patients with HR+ and HER2- breast cancer

Cancer

Breast Cancers Breast

Age

People18+

Phase

I

Trial Acronym

Olema

More information

Trial Identifiers

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Trial sponsor

Olema Pharmaceuticals, Inc.

Scientific Title

A Phase 1 Dose Escalation and Dose Expansion Open-label, Multicenter, Study of OP-1250 in Combination with the CDK4/6 Inhibitor Palbociclib in Adult Subjects with Advanced or Metastatic HR-positive, HER2-negative Breast Cancer

Eligibility

Inclusion

1. Hormone receptor-positive (HR+)/ human epidermal growth factor receptor 2-negative (HER2-) disease, as determined in the most recently obtained archival tumor tissue sample from a metastatic site, using locally accepted criteria by the local pathology report.
2. Willing and able to participate and comply with all study requirements and to provide signed and dated informed consent prior to initiation of any study procedures.
3. Histologically- or cytologically-confirmed locally advanced or MBC for which standard curative measures do not exist.
4. Life expectancy more than 6 months, as judged by the Investigator.

Exclusion

 1. Prior or concurrent malignancy whose natural history or treatment may interfere with the safety or efficacy assessment of the investigational regimen as determined by the medical monitor.
2. Known impaired cardiac function or clinically significant cardiac disease, such as ventricular arrhythmia requiring therapy, congestive heart failure (New York Heart Association Functional Classification Class 2B-4), and uncontrolled hypertension (defined as systolic blood pressure greater than 150 mm Hg and/or diastolic blood pressure greater than 100 mm Hg while on anti-hypertensive medications).
3. Myocardial infarction or unstable angina within 6 months prior to the first administration of study drug.
4. History of cerebral vascular disease within 6 months prior to the first administration of study drug.

Inclusion

  • You are able to swallow medication by mouth.
  • Your cancer has not spread to other parts of the body.
  • Your cancer has spread to other parts of the body.

Exclusion

  • You have been diagnosed with a prior or secondary type of cancer.
  • You have certain types of non-cancer medical conditions.
Message

Clinical trials have complex eligibility criteria.

Ask your doctor if this trial could be right for you.

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