ER-Positive, HER2-Negative Breast CancerPhase 1NCT04993430

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

A Phase 1 study testing HRS8807 and HRS8807、SHR6390 in people with ER-Positive, HER2-Negative Breast Cancer, run by Shanghai Hengrui Pharmaceutical Co., Ltd. at 1 site in China.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record

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Trial summary

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). Read more about this study

Who is it for?: Ages 18 to 75 years, women only
Conditions the study is for: ER-Positive, HER2-Negative Breast Cancer
What is being tested?: HRS8807 and HRS8807、SHR6390
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 46 participants
Where: 1 siteChina
Study dates: 26 Oct 2021to 30 Dec 2026
Phase: Phase 1
Are there results?: Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 75 years
Women only
No healthy volunteers
Adult, Older adult

Who may be able to join

Histological diagnosis of metastatic or locally advanced breast cancer; Histologically proven diagnosis of ER-positive, HER2-negative;
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;
Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1;
Expected survival of more than 3 months.

Who cannot join

All patients in monotherapy and or in combination wih phase who are known allergic to HRS8807 or SHR6390 ingredient;
Presence of symptomatic metastatic visceral disease ;
Patients with known active brain metastases;
Clinically serious cardiovascular disease;
Abnormal electrocardiographic (ECG) with clinical significancy by investigator judgement;
Abnormal thyroid function laboratory results;
Active infection or unexplained fever >38.5℃ during screening period or on the day of the first dose.

Trial locations and contacts

1 site in 1 country.

China1 site

Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, 200032

Other trials in China

About this study

Official title: 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

Conditions: ER-Positive, HER2-Negative Breast Cancer
Being tested: HRS8807, HRS8807、SHR6390

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

HRS8807Drug
HRS8807 monotherapy
HRS8807Drug
HRS8807 monotherapy
HRS8807、SHR6390Device
HRS8807 in combination with SHR6390
HRS8807、SHR6390Drug
HRS8807 in combination with SHR6390

Study groups in NCT04993430
Study group	Role	What they receive
Group A	Experimental	HRS8807 monotherapy dose escalation Receives: Drug: HRS8807
Group B	Experimental	HRS8807 monotherapy dose expansion Receives: Drug: HRS8807
Group C	Experimental	HRS8807 in combination with SHR6390 dose escalation Receives: Device: HRS8807、SHR6390
Group D	Experimental	HRS8807 in combination with SHR6390 dose expansion Receives: Drug: HRS8807、SHR6390

What is being measured

The primary outcome is the main question the study is designed to answer.

MTD
Maximum Tolerated Dose (MTD) of HRS8807 monotherapy and in combination with SHR6390
Measured: Change From Baseline at 28 days
RP2D
select the Recommended Phase 2 Dose (RP2D) of HRS8807 monotherapy and in combination with SHR6390
Measured: Change From Baseline at 28 days
Adverse events (AE) and serious AE (SAE)
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]).
Measured: Up to 30 days after end of treatment

Secondary outcomes (23)

Tmax of HRS8807 and the major metabolite after single dose of HRS8807
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Cycle 1 Day 14, Day 15, each cycle is 28 days
Rac of HRS8807 and the major metabolite after multiple dose administration of HRS8807
Measured: Cycle 1 Day 14, Day 15, each cycle is 28 days
AUCss of HRS8807 and the major metabolite after multiple dose administration of HRS8807
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Cycle 1 Day 14, Day 15, each cycle is 28 days
Objective Response Rate (ORR)
Measured: baseline to the date of first documentation of progression, assessed approximately up to 6 months after the last entered participant
Duration of Response (DoR)
Measured: baseline to the date of first documentation of progression, assessed approximately up to 6 months after the last entered participant
Progression Free Survival (PFS)
Measured: baseline to the date of first documentation of progression, assessed approximately up to 6 months after the last entered participant

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

26 Oct 202130 Dec 2026

First posted6 Aug 2021
Study start26 Oct 2021
Primary completion30 Dec 2026 (estimated)
Study completion30 Dec 2026 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for ER-Positive, HER2-Negative Breast CancerStudies of the same condition, open and under way.
More trials run by Shanghai Hengrui Pharmaceutical Co., Ltd.The sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Single group
Model description: HRS8807 monotherapy and in combination with SHR6390
Masking: None (open label)
Enrolment: 46 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04993430
Sponsor's protocol ID: HRS8807-I-101
Status last verified: May 2026
First submitted: 20 Jul 2021
Last updated: 28 May 2026
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Undecided

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 28 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: 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
ClinicalTrials.gov ID: NCT04993430
Acronym / sponsor ID: HRS8807-I-101
Conditions: ER-Positive, HER2-Negative Breast Cancer
Phase: Phase 1
Study type: Interventional
Recruitment status: Active, not recruiting
Enrolment: 46 participants (actual)
Lead sponsor: Shanghai Hengrui Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
Study start: 26 Oct 2021 (actual)
Primary completion: 30 Dec 2026 (estimated)
Study completion: 30 Dec 2026 (estimated)
First posted: 6 Aug 2021 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Number of arms: 4
Model description: HRS8807 monotherapy and in combination with SHR6390

Arm	Type	Receives
Group A	Experimental	Drug: HRS8807HRS8807 monotherapy dose escalation
Group B	Experimental	Drug: HRS8807HRS8807 monotherapy dose expansion
Group C	Experimental	Device: HRS8807、SHR6390HRS8807 in combination with SHR6390 dose escalation
Group D	Experimental	Drug: HRS8807、SHR6390HRS8807 in combination with SHR6390 dose expansion

Who may qualify

Ages: 18 to 75 years
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Histological diagnosis of metastatic or locally advanced breast cancer; Histologically proven diagnosis of ER-positive, HER2-negative;
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;
Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1;
Expected survival of more than 3 months.

Key exclusion criteria (7 listed)

All patients in monotherapy and or in combination wih phase who are known allergic to HRS8807 or SHR6390 ingredient;
Presence of symptomatic metastatic visceral disease ;
Patients with known active brain metastases;
Clinically serious cardiovascular disease;
Abnormal electrocardiographic (ECG) with clinical significancy by investigator judgement;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
HRS8807HRS8807 monotherapy	Drug	Group A
HRS8807HRS8807 monotherapy	Drug	Group B
HRS8807、SHR6390HRS8807 in combination with SHR6390	Device	Group C
HRS8807、SHR6390HRS8807 in combination with SHR6390	Drug	Group D

Primary outcome

MTD
Time frame: Change From Baseline at 28 days
Maximum Tolerated Dose (MTD) of HRS8807 monotherapy and in combination with SHR6390
RP2D
Time frame: Change From Baseline at 28 days
select the Recommended Phase 2 Dose (RP2D) of HRS8807 monotherapy and in combination with SHR6390
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]).

23 secondary outcomes

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)
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)
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)
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)
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)
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)
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)
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2026.
Individual participant dataSharing planned: Undecided

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing HRS8807 and HRS8807、SHR6390 in people with ER-Positive, HER2-Negative Breast Cancer, run by Shanghai Hengrui Pharmaceutical Co., Ltd. at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 28 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

MTD (time frame: Change From Baseline at 28 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04993430.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 May 2026.