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New drug duo takes on Hard-to-Treat breast cancer

NCT ID NCT05266105

Disease control Sponsor: Olema Pharmaceuticals, Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This early-stage trial tests a new drug called OP-1250 combined with an approved targeted therapy, palbociclib, in 60 adults with advanced or metastatic HR-positive, HER2-negative breast cancer. The goal is to find the safest dose and see if the combination can slow tumor growth. Participants must have cancer that has spread and not responded to prior treatments.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Palazestrant (OP-1250) and palbociclib (Ibrance)
What this could lead to
If successful, this combination could offer a new treatment option for people with advanced hormone-positive breast cancer that has stopped responding to standard therapies.
What could go wrong
This is an early Phase 1 trial with only 60 participants, focused on safety and dosing. It is too small and early to know if the combination will work better than existing treatments, and side effects are still being identified.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

60 people

The number who actually took part.

Started

Dec 2021

Expected to finish

Mar 2026

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Confirmed and evaluable locally advanced or metastatic breast cancer * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 * Must not have received prior oral endocrine or targeted therapy ≤ 2 weeks prior to first dose * Must not have received prior chemotherapy, antibody therapy, or investigational therapy ≤ 4 weeks prior to the first dose * Prior radiotherapy must have been completed 2 weeks prior to first dose * Adequate safety laboratory tests * Willingness to use effective contraception Exclusion Criteria: * Gastrointestinal disease * Significant hepatic disease * Significant cardiovascular disease * Significant ECG abnormalities * History of pulmonary embolism or high risk of thrombosis * Known HIV infection * Active infection (requiring antimicrobial therapy) * Pregnant

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Conditions

The condition(s) this trial relates to.

breast cancer breast neoplasm hormone receptor-positive breast cancer

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Breast cancer

Contacts and locations

Locations

  • Clinical Trial Site

    Waratah, New South Wales, 2298, Australia

  • Clinical Trial Site

    Westmead, New South Wales, 2145, Australia

  • Clinical Trial Site

    South Brisbane, Queensland, 4101, Australia

  • Clinical Trial Site

    Southport, Queensland, 4215, Australia

  • Clinical Trial Site

    Clayton, Victoria, 3168, Australia

  • Clinical Trial Site

    Frankston, Victoria, 3199, Australia

  • Clinical Trial Site

    Geelong, Victoria, 3220, Australia

  • Clinical Trial Site

    Nedlands, Western Australia, 6009, Australia

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