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New drug combo HRS8807 and SHR6390 targets tough breast cancer

NCT ID NCT04993430

Disease control Sponsor: Shanghai Hengrui Pharmaceutical Co., Ltd. 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This early-phase trial tests a new drug called HRS8807, alone or with another drug SHR6390, in 46 people with ER-positive, HER2-negative breast cancer that has spread or cannot be removed. The main goal is to find safe doses and check for side effects. Participants have already tried hormone therapy and up to two chemotherapy treatments.

What this could mean

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

Active substance
HRS8807 (a drug) and SHR6390 (a drug)
What this could lead to
If it works, this could point toward a new treatment option for people with ER-positive, HER2-negative advanced breast cancer.
What could go wrong
This is a very early Phase 1 trial with only 46 people, so it is mainly checking safety and dosing. It may not lead to an effective treatment.

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

46 people

The number who actually took part.

Started

Oct 2021

Expected to finish

Dec 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 to 75 years

Sex

Female participants only

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: 1. Histological diagnosis of metastatic or locally advanced breast cancer; Histologically proven diagnosis of ER-positive, HER2-negative; 2. At least 1 line of endocrine therapy in the metastatic or advanced setting that had progressed or intolerance; ≤ 2 lines of chemotherapy for metastatic or advanced disease; 3. Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1; 4. Expected survival of more than 3 months. Exclusion Criteria: 1. All patients in monotherapy and or in combination wih phase who are known allergic to HRS8807 or SHR6390 ingredient; 2. Presence of symptomatic metastatic visceral disease ; 3. Patients with known active brain metastases; 4. Clinically serious cardiovascular disease; 5. Abnormal electrocardiographic (ECG) with clinical significancy by investigator judgement; 6. Abnormal thyroid function laboratory results; 7. Active infection or unexplained fever \>38.5℃ during screening period or on the day of the first dose.

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Conditions

The condition(s) this trial relates to.

hormone receptor-positive breast cancer

As listed by the trial registrant

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

ER-positive HER2-negative breast cancer

Contacts and locations

Locations

  • Fudan University Shanghai Cancer Center

    Shanghai, Shanghai Municipality, 200032, China

More trials for these conditions

Other studies related to the condition(s) this trial covers.