A Phase 1 Study of HRS8807 Monotherapy and in Combination With SHR6390 in Subjects With ER-Positive, HER2-Negative Metastatic or Locally Advanced Breast Cancer

May 27, 2026 updated by: Shanghai Hengrui Pharmaceutical Co., Ltd.

A Phase 1, Single Arm, Open-Label, Multicenter Study to Evaluate the Safety, Tolerability and Pharmacokinetic of HRS8807 Monotherapy and in Combination With SHR6390 in Subjects With ER-Positive, HER2-Negative Metastatic or Locally Advanced Breast Cancer

The study is to assess safety and tolerability of HRS8807 monotherapy and in combination with SHR6390 in subjects with metastatic or locally advanced breast cancer in order to estimate the Dose-Limiting Toxicity (DLT), Maximum Tolerated Dose (MTD) and select the Recommended Phase 2 Dose (RP2D).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
46

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • China
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, China, 200032
        • Fudan University Shanghai Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Group A
HRS8807 monotherapy dose escalation
Drug: HRS8807
HRS8807 monotherapy
Experimental: Group B
HRS8807 monotherapy dose expansion
Drug: HRS8807
HRS8807 monotherapy
Experimental: Group C
HRS8807 in combination with SHR6390 dose escalation
Device: HRS8807、SHR6390
HRS8807 in combination with SHR6390
Experimental: Group D
HRS8807 in combination with SHR6390 dose expansion
Drug: HRS8807、SHR6390
HRS8807 in combination with SHR6390

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
MTD
Time Frame: Change From Baseline at 28 days
Maximum Tolerated Dose (MTD) of HRS8807 monotherapy and in combination with SHR6390
Change From Baseline at 28 days
RP2D
Time Frame: Change From Baseline at 28 days
select the Recommended Phase 2 Dose (RP2D) of HRS8807 monotherapy and in combination with SHR6390
Change From Baseline at 28 days
Adverse events (AE) and serious AE (SAE)
Time Frame: Up to 30 days after end of treatment
AEs and SAEs as characterized by frequency and severity (as graded by National Cancer Institute Common Terminology Criteria for Adverse Events [NCI CTCAE version 5.0]).
Up to 30 days after end of treatment

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Tmax of HRS8807 and the major metabolite after single dose of HRS8807
Time Frame: Day 1, Day 2, Day 3 of single dose (3 days before Cycle1)
Day 1, Day 2, Day 3 of single dose (3 days before Cycle1)
Cmax of HRS8807 and the major metabolite after single dose of HRS8807
Time Frame: Day 1, Day 2, Day 3 of single dose (3 days before Cycle1)
Day 1, Day 2, Day 3 of single dose (3 days before Cycle1)
AUC0-t of HRS8807 and the major metabolite after single dose of HRS8807
Time Frame: Day 1, Day 2, Day 3 of single dose (3 days before Cycle1)
Day 1, Day 2, Day 3 of single dose (3 days before Cycle1)
AUC0-∞ of HRS8807 and the major metabolite after single dose of HRS8807
Time Frame: Day 1, Day 2, Day 3 of single dose (3 days before Cycle1)
Day 1, Day 2, Day 3 of single dose (3 days before Cycle1)
t1/2 of HRS8807 and the major metabolite after single dose of HRS8807
Time Frame: Day 1, Day 2, Day 3 of single dose (3 days before Cycle1)
Day 1, Day 2, Day 3 of single dose (3 days before Cycle1)
Vz/F of HRS8807 and the major metabolite after single dose of HRS8807
Time Frame: Day 1, Day 2, Day 3 of single dose (3 days before Cycle1)
Day 1, Day 2, Day 3 of single dose (3 days before Cycle1)
CL/F of HRS8807 and the major metabolite after single dose of HRS8807
Time Frame: Day 1, Day 2, Day 3 of single dose (3 days before Cycle1)
Day 1, Day 2, Day 3 of single dose (3 days before Cycle1)
Tmax,ss of HRS8807 and the major metabolite after multiple dose administration of HRS8807
Time Frame: Cycle 1 Day 14, Day 15, each cycle is 28 days
Cycle 1 Day 14, Day 15, each cycle is 28 days
Cmax,ss of HRS8807 and the major metabolite after multiple dose administration of HRS8807
Time Frame: Cycle 1 Day 14, Day 15, each cycle is 28 days
Cycle 1 Day 14, Day 15, each cycle is 28 days
Cmin,ss of HRS8807 and the major metabolite after multiple dose administration of HRS8807
Time Frame: Cycle 1 Day 14, Day 15, each cycle is 28 days
Cycle 1 Day 14, Day 15, each cycle is 28 days
Rac of HRS8807 and the major metabolite after multiple dose administration of HRS8807
Time Frame: Cycle 1 Day 14, Day 15, each cycle is 28 days
Cycle 1 Day 14, Day 15, each cycle is 28 days
AUCss of HRS8807 and the major metabolite after multiple dose administration of HRS8807
Time Frame: Cycle 1 Day 14, Day 15, each cycle is 28 days
Cycle 1 Day 14, Day 15, each cycle is 28 days
Tmax of HRS8807, the major metabolite and SHR6390 after single dose administration of HRS8807 and SHR6390
Time Frame: Cycle 1 Day 1, Day 2, each cycle is 28 days
Cycle 1 Day 1, Day 2, each cycle is 28 days
Cmax of HRS8807, the major metabolite and SHR6390 after single dose administration of HRS8807 and SHR6390
Time Frame: Cycle 1 Day 1, Day 2, each cycle is 28 days
Cycle 1 Day 1, Day 2, each cycle is 28 days
AUC0-t of HRS8807, the major metabolite and SHR6390 after single dose administration of HRS8807 and SHR6390
Time Frame: Cycle 1 Day 1, Day 2, each cycle is 28 days
Cycle 1 Day 1, Day 2, each cycle is 28 days
Tmax,ss of HRS8807, the major metabolite and SHR6390 after multiple dose administration of HRS8807 and SHR6390
Time Frame: Cycle 1 Day 14, Day 15, each cycle is 28 days
Cycle 1 Day 14, Day 15, each cycle is 28 days
Cmax,ss of HRS8807, the major metabolite and SHR6390 after multiple dose administration of HRS8807 and SHR6390
Time Frame: Cycle 1 Day 14, Day 15, each cycle is 28 days
Cycle 1 Day 14, Day 15, each cycle is 28 days
Cmin,ss of HRS8807, the major metabolite and SHR6390 after multiple dose administration of HRS8807 and SHR6390
Time Frame: Cycle 1 Day 14, Day 15, each cycle is 28 days
Cycle 1 Day 14, Day 15, each cycle is 28 days
AUCss of HRS8807, the major metabolite and SHR6390 after multiple dose administration of HRS8807 and SHR6390
Time Frame: Cycle 1 Day 14, Day 15, each cycle is 28 days
Cycle 1 Day 14, Day 15, each cycle is 28 days
Rac of HRS8807, the major metabolite and SHR6390 after multiple dose administration of HRS8807 and SHR6390
Time Frame: Cycle 1 Day 14, Day 15, each cycle is 28 days
Cycle 1 Day 14, Day 15, each cycle is 28 days
Objective Response Rate (ORR)
Time Frame: baseline to the date of first documentation of progression, assessed approximately up to 6 months after the last entered participant
baseline to the date of first documentation of progression, assessed approximately up to 6 months after the last entered participant
Duration of Response (DoR)
Time Frame: baseline to the date of first documentation of progression, assessed approximately up to 6 months after the last entered participant
baseline to the date of first documentation of progression, assessed approximately up to 6 months after the last entered participant
Progression Free Survival (PFS)
Time Frame: baseline to the date of first documentation of progression, assessed approximately up to 6 months after the last entered participant
baseline to the date of first documentation of progression, assessed approximately up to 6 months after the last entered participant

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Shanghai Hengrui Pharmaceutical Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 26, 2021

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 30, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 30, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 20, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 5, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 6, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 28, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 27, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • HRS8807-I-101

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Conditions

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