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Advanced Unresectable or Metastatic Breast CancerPhase 1/2NCT06679036

A Trial of HRS-2189 in Combination With Fluvastatin±HRS-6209, or HRS-8080±HRS-6209, or HRS-6209+HRS-1358 in Breast Cancer Patients

A Phase 1/2 study testing HRS-2189, Fluvustat and HRS-8080 in people with Advanced Unresectable or Metastatic Breast Cancer, run by Shandong Suncadia Medicine Co., Ltd. at 2 sites in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

The study is being conducted to evaluate the efficacy, and safety of dexmedetomidine hydrochloride nasal spray for preoperative sedation in adults. To explore the reasonable dosage of dexmedetomidine hydrochloride nasal spray for preoperative sedation. Read more about this study

Who is it for?
Ages 18 to 75 years, women only
What is being tested?
HRS-2189, Fluvustat and HRS-8080
Could I receive a placebo?
No, everyone receives an active treatment
How many people
300 participants
Where
2 sitesChina
Study dates
21 Jan 2025to 31 Dec 2026
Phase
Phase 1/2
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

  • ECOG physical condition 0-1 point.
  • Advanced unresectable or metastatic breast cancer confirmed by histopathology or cytopathology.
  • Menopausal Status.
  • Previous treatments: (New) adjuvant endocrine therapy combined or not combined with CDK4/6 inhibitors during or within 12 months after treatment, including recurrence/metastasis, shall be counted as one line of endocrine therapy and one line of CDK4/6 inhibitor therapy (such as combined CDK4/6 inhibitors); Relapse/metastasis during (new) adjuvant chemotherapy or within 6 months after the end of treatment (whichever occurs later), counted as one line of chemotherapy.
  • Disease progression confirmed by imaging during or after the last systemic anti-tumor treatment before the first use of medication (limited to the stage of efficacy expansion).
  • There must be at least one measurable extracranial lesion that meets RECIST v1.1 at baseline.
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  • Expected survival>3 months.
  • The functional level of 8 organs is good.
  • Previous treatments: The interval between receiving nitrosourea or mitomycin C before the first medication in this study was ≥ 6 weeks; Receiving cytotoxic drugs, endocrine therapy, immunotherapy, targeted therapy, surgical interval (excluding biopsy or PICC catheterization or PORT infusion port catheterization surgery), or other clinical studies with the last dose of medication ≥ 4 weeks; The interval between the end of radiotherapy is ≥ 2 weeks.
  • female participants with fertility must agree to use efficient contraceptive measures for contraception during the study treatment period and within 7 months after the end of the study treatment period; Female subjects with fertility must have a negative serum HCG test within 7 days prior to enrollment in the study and must be non lactating.
  • Voluntarily participate in this clinical trial, willing and able to comply with the clinical visit and research related procedures, understand the research procedures, and have signed informed consent.

Who cannot join

  • Patients with active (uncontrolled or symptomatic) brain metastases, cancerous meningitis, spinal cord compression, or a history of primary CNS tumors; patients with brain metastases who have completed treatment at least 28 days prior to first use of the study drug and are asymptomatic can be considered for enrollment if they have been confirmed asymptomatic by cranial imaging studies such as CT, MRI, or venography without evidence of cerebral hemorrhage, and have completed treatment at least 28 days before the first use of the study drug.
  • Patients with a history of severe cardiovascular disease, including: (1) Congestive heart failure (NYHA Class>2); (2) Severe/unstable angina, new angina within the last 3 months; (3) Myocardial ischemia requiring long-term medication control; patients with NYHA Class III-IV heart failure; (4) Acute myocardial infarction within the last 6 months; (5) Any grade 2 or higher supraventricular or ventricular arrhythmia that requires treatment or intervention; (6) Atrial fibrillation, coronary/peripheral artery bypass grafts, or cerebrovascular symptoms including transient ischemic attacks.
  • Patients with factors affecting oral medication intake, such as difficulty swallowing or intestinal obstruction, or have active gastrointestinal diseases or other diseases that may significantly affect drug absorption, distribution, metabolism, or excretion (active inflammatory bowel disease or chronic diarrhea, enterocolitis or upper gastrointestinal surgery, including gastrectomy).
  • Patients with uncontrollable third space effusions (such as large ascites, pleural effusion, pericardial effusion) or cancerous lymphedema.
  • Pregnant women, nursing mothers, or those planning to become pregnant during the study period.
  • Patients with significant liver disease history, untreated active hepatitis B (defined as positivity for HBsAg or HBcAb and HBV-DNA levels above the normal upper limit), or active hepatitis C (defined as HCV-RNA levels above the detection limit).
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  • Patients with uncontrolled chronic systemic comorbidities (such as severe chronic lung, liver, kidney or heart diseases).
  • Patients with active autoimmune diseases, history of immune deficiency, autoimmune disease history, or history of diseases or syndromes requiring systemic corticosteroid hormones or immunosuppressive drug therapy, or have acquired (HIV infection) or congenital immunodeficiency diseases, or have a history of organ transplantation (including homologous bone marrow transplantation).
  • Patients with active infectious tuberculosis and need for antimicrobial treatment.
  • Patients with known significant liver disease history, untreated active hepatitis B (defined as positivity for HBsAg or HBcAb and HBV-DNA levels above the normal upper limit), or active hepatitis C (defined as HCV-RNA levels above the detection limit).
  • Patients who have had other malignancies within the past 5 years, except: 1) Completely cured skin basal cell carcinoma and cervical intraepithelial neoplasia; 2) Completely cured and without recurrence of secondary primary cancer within 5 years.
  • Patients who have used strong or moderate inhibitors of CYP3A4 within 1 week before the first dose or strong or moderate inducers of CYP3A4 within 2 weeks before the first dose.
  • Pregnant women, nursing mothers, or those planning to become pregnant during the study period.
  • Patients with a history of neurological or psychiatric disorders, or those with a history of abuse of psychotropic drugs or drug addiction.
  • Patients who are expected to receive other anti-tumor treatments or medications during this study.
  • Patients with other serious physical or laboratory abnormalities that may increase the risk of participating in the study or interfere with study results, and those deemed by the investigator not suitable for participation in this study.
  • Patients with anti-tumor treatment-related toxicity in the past (excluding alopecia; according to the judgment of the investigator， after consultation with the sponsor, some tolerable chronic Grade II toxicities may be excluded).
  • Patients who have an allergy to any study drug or any excipient.

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Xia Zhang, M.M contact

+86-0518-81220121

xia.zhang@hengrui.com

China2 sites, 2 recruiting

  • Harbin Medical University Affiliated Cancer Hospital

    Harbin, Heilongjiang, 150081

    Qingyuan Zhang, +86-0451-86298192, 13313612989@163.com

    Qingyuan Zhang

    Recruiting

  • Henan Cancer Hospital

    Zhengzhou, Henan, 450000

    Min Yan, +86-0371-65588404, ym200678@126.com

    Min Yan

    Recruiting

Other trials in China

About this study

Official title: An Open, Multicenter Phase Ib/II Clinical Study on the Safety, Tolerance, Pharmacokinetics, and Initial Efficacy of HRS-2189 in Combination With Fluvastatin±HRS-6209, or HRS-8080±HRS-6209, or HRS-6209+HRS-1358 in Patients With Advanced Unresectable or Metastatic Breast Cancer

The study is being conducted to evaluate the efficacy, and safety of dexmedetomidine hydrochloride nasal spray for preoperative sedation in adults. To explore the reasonable dosage of dexmedetomidine hydrochloride nasal spray for preoperative sedation.

Being tested
HRS-2189, Fluvustat, HRS-8080, HRS-6209, HRS-1358
Medical subject headings
Breast Neoplasms

What participants receive

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

  • HRS-2189Drug

    HRS-2189

  • FluvustatDrug

    Fluvustat

  • HRS-8080Drug

    HRS-8080

  • HRS-6209Drug

    HRS-6209

  • HRS-1358Drug

    HRS-1358

Study groups in NCT06679036
Study groupRoleWhat they receive
Treatment group AExperimentalHRS-2189 in combination with Fluvustat.
Receives: Drug: HRS-2189; Drug: Fluvustat
Treatment group BExperimentalHRS-2189 in combination with HRS-8080.
Receives: Drug: HRS-2189; Drug: HRS-8080
Treatment group CExperimentalHRS-2189 in combination with HRS-6209 and Fluvustat.
Receives: Drug: HRS-2189; Drug: Fluvustat; Drug: HRS-6209
Treatment group DExperimentalHRS-2189 in combination with HRS-6209 and HRS-8080.
Receives: Drug: HRS-2189; Drug: HRS-8080; Drug: HRS-6209
Treatment group EExperimentalHRS-2189 in combination with HRS-6209 and HRS-1358.
Receives: Drug: HRS-2189; Drug: HRS-6209; Drug: HRS-1358

What is being measured

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

  1. AEs+SAEs

    Measured: From the first drug administration to within 30 days for the last treatment dose.

  2. Dose limited toxicity (DLT)

    Measured: Up to 28 days.

  3. Maximum tolerated dose (MTD)

    Measured: Up to 28 days.

  4. Recommended Phase II Dose (RP2D)

    Measured: Up to 28 days.

  5. ORR (objective response rate) - Stage II (efficacy expansion)

    Measured: Every 8 weeks lasting about one year.

Secondary outcomes (12)

  1. Evaluation of pharmacokinetic parameter: Cmax,ss

    Measured: 2 months.

  2. Evaluation of pharmacokinetic parameter: Tmax,ss

    Measured: 2 months.

  3. Evaluation of pharmacokinetic parameter: Cmin,ss

    Measured: 2 months.

  4. Evaluation of pharmacokinetic parameter: AUCss

    Measured: 2 months.

  5. Best Overall Response (BOR)

    Measured: Every 8 weeks lasting about one year.

  6. Duration of Response (DoR)

    Measured: Every 8 weeks lasting about one year.

  7. Disease Control Rate (DCR)

    Measured: Every 8 weeks lasting about one year.

  8. Clinical Benefit Rate (CBR)

    Measured: Every 8 weeks lasting about one year.

  9. Progression Free Survival (PFS)

    Measured: Every 8 weeks lasting about one year.

  10. Changes in antibody levels in PBMCs relative to baseline

    Measured: 1 month.

  11. Evaluate the correlation between target amplification and clinical efficacy

    Measured: From the first drug administration to within 30 days for the last treatment dose.

  12. Evaluation of the correlation between gene mutations in ctDNA and clinical efficacy, as well as the mechanism of drug resistance.

    Measured: From the first drug administration to within 30 days for the last treatment dose.

Timeline

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

  1. First posted7 Nov 2024
  2. Study start21 Jan 2025
  3. Primary completion30 Oct 2026 (estimated)
  4. Study completion31 Dec 2026 (estimated)

Resources

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 1/2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
300 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06679036
Sponsor's protocol ID
HRS-2189-201-BC
Status last verified
Feb 2026
First submitted
6 Nov 2024
Last updated
2 Mar 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing HRS-2189, Fluvustat and HRS-8080 in people with Advanced Unresectable or Metastatic Breast Cancer, run by Shandong Suncadia Medicine Co., Ltd. at 2 sites 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 11 inclusion and 18 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: looking for participants now, as of the sponsor's last update on 2 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites 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 combined 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.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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?

Contact Xia Zhang, M.M (+86-0518-81220121, xia.zhang@hengrui.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

AEs+SAEs (time frame: From the first drug administration to within 30 days for the last treatment dose.). The study lists 5 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 NCT06679036.

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 2 Mar 2026; AzTrials last refreshed its copy on 8 Nov 2026.

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