Advanced Unresectable or Metastatic Breast Cancer of AdultsPhase 1/2NCT07389733
A Study of HRS-6208 in Combination With HRS-8080, or Fulvestrant, or Letrozole, With or Without HRS-6209 in Patients With Advanced Unresectable or Metastatic Breast Cancer
A Phase 1/2 study testing HRS-6208 Capsule, HRS-6209 Capsule and HRS-8080 Tablet in people with Advanced Unresectable or Metastatic Breast Cancer of Adults, run by Shandong Suncadia Medicine Co., Ltd. at 2 sites in China.
Trial summary
This study aims to evaluate the safety, tolerability, efficacy and pharmacokinetics of HRS-6208 in combination with HRS-8080 ± HRS-6209, or in combination with fulvestrant ± HRS-6209, or in combination with letrozole ± HRS-6209 in patients with advanced unresectable or metastatic breast cancer. Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Advanced Unresectable or Metastatic Breast Cancer of Adults
- What is being tested?
- HRS-6208 Capsule, HRS-6209 Capsule and HRS-8080 Tablet
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 2 sitesChina
- Study dates
- 27 Mar 2026to Dec 2028
- 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
- Female, aged 18-75 (inclusive);
- ECOG score 0-1;
- Estimated survival time ≥ 12 weeks;
- Possessing adequate bone marrow and organ function;
- Participants of reproductive/childbearing potential must agree to take adequate and effective contraceptive measures from the time they sign the informed consent form, during the study treatment period, and up to 2 years after the last use of the trial medication;
- Participants must provide informed consent for this study before the trial and voluntarily sign a written informed consent form.
Who cannot join
- Within 5 years prior to the first dose of study medication, the occurrence of other malignancies, except for fully treated cervical carcinoma in situ, basal cell or squamous cell skin cancer, and post-radical surgery thyroid papillary carcinoma;
- Active brain metastasis, carcinomatous meningitis, spinal cord compression, or history of primary central nervous system tumors;
- Severe bone damage caused by tumor bone metastasis as determined by the investigator;
- Adverse events caused by previous anti-tumor treatment have not been resolved;
- Participants with one of multiple factors affecting oral medication;
- History of severe cardiovascular and cerebrovascular diseases;
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- Presence of severe infections;
- Significant clinically meaningful bleeding within 3 months prior to the first dose of study medication;
- Active autoimmune diseases, history of immune deficiency, history of autoimmune diseases, or history of diseases or syndromes requiring systemic steroid hormone or immunosuppressive drug treatment, or acquired conditions (HIV infection), congenital immune deficiency diseases, or history of organ transplantation;
- Active untreated hepatitis;
- History of active tuberculosis infection within 1 year prior to enrollment, or history of active tuberculosis infection more than 1 year ago without standard treatment;
- Washout period of prior drug or treatment did not meet protocol requirements before the first dose of study medication;
- Prior use of prohibited drugs specified in the protocol;
- Is pregnant or breastfeeding or planning to become pregnant within 2 years after the last dose of study medication;
- History of clear neurological or psychiatric disorders, and participants with a history of psychiatric drug abuse or drug addiction;
- Allergic reactions to any study drug or excipients;
- Factors confirmed by the investigator as unsuitable for participation in this clinical study.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China2 sites, 2 recruiting
- Recruiting
West China Hospital, Sichuan University
Chengdu, Sichuan, 610044
Ting Luo, +86-028-85553329, luoting@wchscu.cn
Ting Luo
- Recruiting
The Second Affiliated Hospital of Dalian Medical University
Dalian, Liaoning, 116031
Man Li, +86-0411-84671291, dyeyliman7@sohu.com
Man Li
About this study
Official title: Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of HRS-6208 in Combination With HRS-8080 ± HRS-6209, or in Combination With Fulvestrant ± HRS-6209, or in Combination With Letrozole ± HRS-6209 in Patients With Advanced Unresectable or Metastatic Breast Cancer: an Open Label, Multicenter, Phase Ib/II Study
This study aims to evaluate the safety, tolerability, efficacy and pharmacokinetics of HRS-6208 in combination with HRS-8080 ± HRS-6209, or in combination with fulvestrant ± HRS-6209, or in combination with letrozole ± HRS-6209 in patients with advanced unresectable or metastatic breast cancer.
- Being tested
- HRS-6208 Capsule, HRS-6209 Capsule, HRS-8080 Tablet, Fulvestrant injection, Letrozole tablets
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HRS-6208 CapsuleDrug
HRS-6208 capsule.
HRS-6209 CapsuleDrug
HRS-6209 capsule.
HRS-8080 TabletDrug
HRS-8080 tablet.
Fulvestrant injectionDrug
Fulvestrant injection.
Letrozole tabletsDrug
Letrozole tablets.
| Study group | Role | What they receive |
|---|---|---|
| Arm A: HRS-6208 + HRS-8080 ± HRS-6209 | Experimental | HRS-6208 + HRS-8080 ± HRS-6209. Receives: Drug: HRS-6208 Capsule; Drug: HRS-6209 Capsule; Drug: HRS-8080 Tablet |
| Arm B: HRS-6208 + Fulvestrant ± HRS-6209 | Experimental | HRS-6208 + Fulvestrant ± HRS-6209. Receives: Drug: HRS-6208 Capsule; Drug: HRS-6209 Capsule; Drug: Fulvestrant injection |
| Arm C: HRS-6208 + Letrozole ± HRS-6209 | Experimental | HRS-6208 + Letrozole ± HRS-6209. Receives: Drug: HRS-6208 Capsule; Drug: HRS-6209 Capsule; Drug: Letrozole tablets |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose-limiting toxicity (DLT)
Measured: The DLT will be evaluated for the last participant in each dose group 28 days after the first dose.
Recommended phase II dose (RP2D)
Measured: The evaluation of RP2D will be completed approximately one year later than DLT evaluation.
Incidence and severity of adverse events (AEs)
Measured: Each individual participant will be followed for approximately 8 months, and the entire study process will last for approximately 36 months.
Objective response rate (ORR)
Measured: For a single subject, the duration will be approximately 8 months, while the entire research process will last for 36 months.
Secondary outcomes (8)
Disease control rate (DCR)
Measured: The duration for a single subject will be approximately 8 months, and the entire research process will last for 36 months.
Duration of response (DoR)
Measured: The duration for a single subject will be approximately 8 months, and the entire research process will last for 36 months.
Progression-free survival (PFS)
Measured: The duration for a single subject will be approximately 8 months, and the entire research process will last for 36 months.
Overall survival (OS)
Measured: The duration for a single subject will be approximately 8 months, and the entire research process will last for 36 months.
The blood drug concentration of HRS-6208
Measured: The duration for a single subject will be approximately 8 months, and the entire research process will last for 36 months.
The blood drug concentration of HRS-8080
Measured: The duration for a single subject will be approximately 8 months, and the entire research process will last for 36 months.
The blood drug concentration of HRS-6209
Measured: The duration for a single subject will be approximately 8 months, and the entire research process will last for 36 months.
The blood drug concentration of Letrozole
Measured: The duration for a single subject will be approximately 8 months, and the entire research process will last for 36 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2026
- Study start27 Mar 2026
- Primary completionDec 2028 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Unresectable or Metastatic Breast Cancer of AdultsStudies of the same condition, open and under way.
- More trials run by Shandong Suncadia Medicine 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 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Model description
- An open label, multicenter, phase Ib/II study.
- Masking
- None (open label)
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shandong Suncadia Medicine Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07389733
- Sponsor's protocol ID
- HRS-6208-201-BC
- Status last verified
- Mar 2026
- First submitted
- 29 Jan 2026
- Last updated
- 3 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of HRS-6208 in Combination With HRS-8080 ± HRS-6209, or in Combination With Fulvestrant ± HRS-6209, or in Combination With Letrozole ± HRS-6209 in Patients With Advanced Unresectable or Metastatic Breast Cancer: an Open Label, Multicenter, Phase Ib/II Study
- ClinicalTrials.gov ID
- NCT07389733
- Acronym / sponsor ID
- HRS-6208-201-BC
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Shandong Suncadia Medicine Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 27 Mar 2026 (actual)
- Primary completion
- Dec 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 5 Feb 2026 (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.
This study aims to evaluate the safety, tolerability, efficacy and pharmacokinetics of HRS-6208 in combination with HRS-8080 ± HRS-6209, or in combination with fulvestrant ± HRS-6209, or in combination with letrozole ± HRS-6209 in patients with advanced unresectable or metastatic breast cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- An open label, multicenter, phase Ib/II study.
| Arm | Type | Receives |
|---|---|---|
| Arm A: HRS-6208 + HRS-8080 ± HRS-6209 | Experimental | Drug: HRS-6208 Capsule, Drug: HRS-6209 Capsule, Drug: HRS-8080 TabletHRS-6208 + HRS-8080 ± HRS-6209. |
| Arm B: HRS-6208 + Fulvestrant ± HRS-6209 | Experimental | Drug: HRS-6208 Capsule, Drug: HRS-6209 Capsule, Drug: Fulvestrant injectionHRS-6208 + Fulvestrant ± HRS-6209. |
| Arm C: HRS-6208 + Letrozole ± HRS-6209 | Experimental | Drug: HRS-6208 Capsule, Drug: HRS-6209 Capsule, Drug: Letrozole tabletsHRS-6208 + Letrozole ± HRS-6209. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Female, aged 18-75 (inclusive);
- ECOG score 0-1;
- Estimated survival time ≥ 12 weeks;
- Possessing adequate bone marrow and organ function;
- Participants of reproductive/childbearing potential must agree to take adequate and effective contraceptive measures from the time they sign the informed consent form, during the study treatment period, and up to 2 years after the last use of the trial medication;
Key exclusion criteria (17 listed)
- Within 5 years prior to the first dose of study medication, the occurrence of other malignancies, except for fully treated cervical carcinoma in situ, basal cell or squamous cell skin cancer, and post-radical surgery thyroid papillary carcinoma;
- Active brain metastasis, carcinomatous meningitis, spinal cord compression, or history of primary central nervous system tumors;
- Severe bone damage caused by tumor bone metastasis as determined by the investigator;
- Adverse events caused by previous anti-tumor treatment have not been resolved;
- Participants with one of multiple factors affecting oral medication;
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 |
|---|---|---|
| HRS-6208 CapsuleHRS-6208 capsule. | Drug | Arm A: HRS-6208 + HRS-8080 ± HRS-6209, Arm B: HRS-6208 + Fulvestrant ± HRS-6209, Arm C: HRS-6208 + Letrozole ± HRS-6209 |
| HRS-6209 CapsuleHRS-6209 capsule. | Drug | Arm A: HRS-6208 + HRS-8080 ± HRS-6209, Arm B: HRS-6208 + Fulvestrant ± HRS-6209, Arm C: HRS-6208 + Letrozole ± HRS-6209 |
| HRS-8080 TabletHRS-8080 tablet. | Drug | Arm A: HRS-6208 + HRS-8080 ± HRS-6209 |
| Fulvestrant injectionFulvestrant injection. | Drug | Arm B: HRS-6208 + Fulvestrant ± HRS-6209 |
| Letrozole tabletsLetrozole tablets. | Drug | Arm C: HRS-6208 + Letrozole ± HRS-6209 |
Primary outcome
Dose-limiting toxicity (DLT)
Time frame: The DLT will be evaluated for the last participant in each dose group 28 days after the first dose.
Recommended phase II dose (RP2D)
Time frame: The evaluation of RP2D will be completed approximately one year later than DLT evaluation.
Incidence and severity of adverse events (AEs)
Time frame: Each individual participant will be followed for approximately 8 months, and the entire study process will last for approximately 36 months.
Objective response rate (ORR)
Time frame: For a single subject, the duration will be approximately 8 months, while the entire research process will last for 36 months.
8 secondary outcomes
Disease control rate (DCR)
Time frame: The duration for a single subject will be approximately 8 months, and the entire research process will last for 36 months.
Duration of response (DoR)
Time frame: The duration for a single subject will be approximately 8 months, and the entire research process will last for 36 months.
Progression-free survival (PFS)
Time frame: The duration for a single subject will be approximately 8 months, and the entire research process will last for 36 months.
Overall survival (OS)
Time frame: The duration for a single subject will be approximately 8 months, and the entire research process will last for 36 months.
The blood drug concentration of HRS-6208
Time frame: The duration for a single subject will be approximately 8 months, and the entire research process will last for 36 months.
The blood drug concentration of HRS-8080
Time frame: The duration for a single subject will be approximately 8 months, and the entire research process will last for 36 months.
The blood drug concentration of HRS-6209
Time frame: The duration for a single subject will be approximately 8 months, and the entire research process will last for 36 months.
The blood drug concentration of Letrozole
Time frame: The duration for a single subject will be approximately 8 months, and the entire research process will last for 36 months.
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 3 Apr 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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing HRS-6208 Capsule, HRS-6209 Capsule and HRS-8080 Tablet in people with Advanced Unresectable or Metastatic Breast Cancer of Adults, 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 6 inclusion and 17 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 3 Apr 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 Yunxia Feng (+86-0518-82342973, yunxia.feng.yf29@hengrui.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dose-limiting toxicity (DLT) (time frame: The DLT will be evaluated for the last participant in each dose group 28 days after the first dose.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 Apr 2026.