Advanced Unresectable or Metastatic Breast CancerPhase 1/2NCT06555068
A Trial of HRS-6209 in Combination With Other Antitumor Therapies in Breast Cancer Patients or HRS-9813 as Monotherapy in Patients With Advanced Solid Tumors
A Phase 1/2 study testing HRS-6209 in Combination with Fulvestrant, HRS-6209 in Combination with HRS-1358 and HRS-6209 in Combination with Letrozole in people with Advanced Unresectable or Metastatic Breast Cancer and Advanced Solid Tumors, run by Jiangsu HengRui Medicine Co., Ltd. at 1 site in China.
Trial summary
The study is being conducted to evaluate the safety, PK and efficacy of HRS-6209 in Combination with Fulvestrant, Letrozole, HRS-8080, HRS-1358 ,or HRS-9813 and HRS-8080，or letrozole and trastuzumab, with or without pertuzumab, or HRS-4508 and letrozole, with or without trastuzumab and/or pertuzumab, for advanced… 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, Advanced Solid Tumors
- What is being tested?
- HRS-6209 in Combination with Fulvestrant, HRS-6209 in Combination with HRS-1358 and HRS-6209 in Combination with Letrozole
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 528 participants
- Where
- 1 siteChina
- Study dates
- 12 Aug 2024to Aug 2028
- Phase
- Phase 1/2
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
- Females aged 18-75 years (inclusive);
- ECOG performance status (PS) score of 0-1;
- Patients with histopathologically confirmed metastatic or unresectable locally advanced breast cancer;
- Patients with advanced malignant solid tumors confirmed by histopathology or cytopathology, who have failed standard treatment, or for whom no effective standard treatment regimen is available, or who are unable to receive further standard treatment.
- Menopausal status:
- Having had bilateral oophorectomy, or aged ≥ 60 years old; or
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- Aged < 60, natural menopause (defined as spontaneous cessation of regular menses for at least 12 consecutive months in the absence of other pathological or physiological causes) with E2 and FSH at postmenopausal levels; or
- Premenopausal or perimenopausal patients, agree to start or continue receive LHRH agonists during the study (exclude from the QT/QTc group).
- Disease progression evidenced by imaging during or after the last systemic anti-tumor treatment prior to the first dose (limited to the efficacy expansion stage);
- With at least one extracranial measurable target lesion at baseline per RECIST v1.1;
- Life expectancy of > 3 months;
- Adequate organ and marrow function as defined by the protocol;Female subjects of childbearing potential should agree to adopt effective contraceptive measures during the study period and within 7months after the end of the study treatment; female subjects of childbearing potential must have a negative serum HCG test result within 7 days before enrollment in the study and must not be in the lactation;
- Voluntarily participate in this clinical study, be willing and able to comply with procedures related to clinical visits and study, and understand and have signed written informed consent.
Who cannot join
- With symptomatic visceral metastases deemed unfit for endocrine therapy by the investigator;
- With active brain metastases, carcinomatous meningitis, spinal cord compression, or a history of primary tumors of the central nervous system;
- History of clinically significant cardiovascular disease, including;
- Abnormal ECG findings, which are judged by the investigator to be clinically significant and and need to intervene;
- Previous use of fulvestrant for cohort of HRS-6209 in combination with fulvestrant (efficacy expansion stage).
- With factors that affect oral medication, active gastrointestinal diseases, or other diseases that may obviously affect drug absorption, distribution, metabolism, or excretion;
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- With clinically significant endometrial abnormalities, including but not limited to endometrial hyperplasia and dysfunctional uterine bleeding;
- Active infection or unexplained fever > 38.5 °C during the screening period or on the day of first dose;
- With uncontrollable chronic systemic complications as judged by the investigator.
- With active autoimmune diseases, history of immunodeficiency and history of autoimmune diseases, history of diseases or syndromes that require systemic corticosteroids or immunosuppressive drugs, other acquired (HIV infection) or congenital immunodeficiency, or history of organ transplantation (including allogeneic bone marrow transplantation);
- With acute infection or active tuberculosis requiring medication.
- With a known history of clinically significant liver disease, untreated active hepatitis;
- Had other concurrent malignant tumors in the past 5 years, except: 1. Cervical carcinoma in situ that has been cured, 2. Second primary cancer that has been cured without recurrence within five years;
- Use of moderate and strong CYP3A4 inhibitors within 1 week or moderate and strong CYP3A4 inducers within 2 weeks prior to the first dose;
- Use of any drugs with the risk of prolonging QT/QTc interval or causing torsade de pointes (TdP) within 4 weeks prior to the first dose, and with previous congenital QT interval prolongation syndrome or a family history of QT interval prolongation, implanted pacemakers or automatic implantable cardioverter defibrillators, uncorrectable electrolyte disorders, and other factors that may affect the QT/QTc study;
- Surgical treatment (except for needle biopsy or PICC catheterization or PORT catheterization), chemotherapy (except for 5-Fu drugs), immunotherapy, macromolecular targeted therapy, etc. within 4 weeks before the first dose; Received endocrine therapy, 5-FU chemotherapy or radiotherapy within 2 weeks before the first dose; Small molecule targeted drugs need to be washed out for 2 weeks or 5 half-lives (whichever is longer);
- Pregnant or lactating women, or females planning to become pregnant during the study period;
- With clear history of neural or mental disorders or with history of psychotropic abuse or drug abuse;
- 20) Subjects who are expected to receive other anti-tumor therapies or drugs during this study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, 200032
Jiong Wu
About this study
Official title: An Open-Label, Multi-Center Phase Ib/II Clinical Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of HRS-6209 in Combination With Other Antitumor Therapies in Patients With Advanced Unresectable or Metastatic Breast Cancer or HRS-9813 as Monotherapy in Patients With Advanced Solid Tumors
The study is being conducted to evaluate the safety, PK and efficacy of HRS-6209 in Combination with Fulvestrant, Letrozole, HRS-8080, HRS-1358 ,or HRS-9813 and HRS-8080，or letrozole and trastuzumab, with or without pertuzumab, or HRS-4508 and letrozole, with or without trastuzumab and/or pertuzumab, for advanced unresectable or metastatic breast cancer or HRS-9813 as monotherapy in Patients with Advanced Solid Tumors
- Being tested
- HRS-6209 in Combination with Fulvestrant, HRS-6209 in Combination with HRS-1358, HRS-6209 in Combination with Letrozole, HRS-6209 in Combination with HRS-8080, HRS-6209 in Combination with HRS-9813 and Letrozole
- 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-6209 in Combination with FulvestrantDrug
HRS-6209 in Combination with Fulvestrant
HRS-6209 in Combination with HRS-1358Drug
HRS-6209 in Combination with HRS-1358
HRS-6209 in Combination with LetrozoleDrug
HRS-6209 in Combination with Letrozole
HRS-6209 in Combination with HRS-8080Drug
HRS-6209 in Combination with HRS-8080
HRS-6209 in Combination with HRS-1358Drug
HRS-6209 in Combination with HRS-1358
HRS-6209 in Combination with HRS-9813 and LetrozoleDrug
HRS-6209 in Combination with HRS-9813 and Letrozole
HRS-6209 in Combination with HRS-9813 and HRS-8080Drug
HRS-6209 in Combination with HRS-9813 and HRS-8080
HRS-6209 in Combination with letrozole and trastuzumabDrug
HRS-6209 in Combination with letrozole and trastuzumab
HRS-6209 in Combination with letrozole and trastuzumab and pertuzumabDrug
HRS-6209 in Combination with letrozole and trastuzumab and pertuzumab
HRS-6209 in Combination HRS-4508 and letrozoleDrug
HRS-6209 in Combination HRS-4508 and letrozole
HRS-6209 in Combination HRS-4508 and letrozole and trastuzumab and pertuzumabDrug
HRS-6209 in Combination HRS-4508 and letrozole and trastuzumab and pertuzumab
| Study group | Role | What they receive |
|---|---|---|
| Treatment group A: HRS-6209 in Combination with Fulvestrant | Experimental | Not described Receives: Drug: HRS-6209 in Combination with Fulvestrant |
| Treatment group E: HRS-6209 in Combination with HRS-1358 | Experimental | Not described Receives: Drug: HRS-6209 in Combination with HRS-1358 |
| Treatment group B：HRS-6209 in Combination with Letrozole | Experimental | Not described Receives: Drug: HRS-6209 in Combination with Letrozole |
| Treatment group C：HRS-6209 in Combination with HRS-8080 | Experimental | Not described Receives: Drug: HRS-6209 in Combination with HRS-8080 |
| Treatment group D：HRS-6209 in Combination with HRS-8080 | Experimental | Not described Receives: Drug: HRS-6209 in Combination with HRS-8080 |
| Treatment group F: HRS-6209 in Combination with HRS-1358 | Experimental | Not described Receives: Drug: HRS-6209 in Combination with HRS-1358 |
| Treatment group G：HRS-6209 in Combination with HRS-9813 and Letrozole | Experimental | Not described Receives: Drug: HRS-6209 in Combination with HRS-9813 and Letrozole |
| Treatment group H：HRS-6209 in Combination with HRS-9813 and HRS-8080 | Experimental | Not described Receives: Drug: HRS-6209 in Combination with HRS-9813 and HRS-8080 |
| Treatment group I：HRS-6209 in Combination with HRS-9813 and HRS-8080 | Experimental | Not described Receives: Drug: HRS-6209 in Combination with HRS-9813 and HRS-8080 |
| Treatment group PART3-A | Experimental | Not described Receives: Drug: HRS-6209 in Combination with letrozole and trastuzumab |
| Treatment group PART3-B | Experimental | Not described Receives: Drug: HRS-6209 in Combination with letrozole and trastuzumab and pertuzumab |
| Treatment group PART3-C- | Experimental | Not described Receives: Drug: HRS-6209 in Combination HRS-4508 and letrozole |
| Treatment group PART3-D | Experimental | Not described Receives: Drug: HRS-6209 in Combination HRS-4508 and letrozole and trastuzumab and pertuzumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
DLT (dose-limiting toxicity)-Stage I (dose exploration)
Measured: 28 days after the first dose
MTD (maximum tolerated dose) -Stage I (dose exploration)
Measured: 28 days after the first dose
RP2D (recommended phase II dose) -Stage I (dose exploration)
Measured: 28 days after the first dose
(Serious) AEs-Stage I (dose exploration)
Measured: every week in Cycle 1 (28 days after the first dose), every 2 weeks in Cycle 2 (28 days after the second dose), every 4 weeks from Cycle 3 and thereafter (28 days after each dose), lasting about one year
ORR ( objective response rate )-Stage II (efficacy expansion)
Measured: every 8 weeks lasting about one year
Secondary outcomes (18)
Cmax, ss (Stage I)
Measured: Cycle 1 (each cycle is 28 days) day 15、Cycle 2 (each cycle is 28 days) 、 Cycle 3 (each cycle is 28 days)、Cycle 4 (each cycle is 28 days)、、Cycle 5 (each cycle is 28 days)、Cycle 6 (each cycle is 28 days)
Tmax, ss (Stage I)
Measured: Cycle 1 (each cycle is 28 days) day 15、Cycle 2 (each cycle is 28 days) 、 Cycle 3 (each cycle is 28 days)、Cycle 4 (each cycle is 28 days)、、Cycle 5 (each cycle is 28 days)、Cycle 6 (each cycle is 28 days)
Cmin, ss(Stage I)
Measured: Cycle 1 (each cycle is 28 days) day 15、Cycle 2 (each cycle is 28 days) 、 Cycle 3 (each cycle is 28 days)、Cycle 4 (each cycle is 28 days)、、Cycle 5 (each cycle is 28 days)、Cycle 6 (each cycle is 28 days)
AUCss (Stage I)
Measured: Cycle 1 (each cycle is 28 days) day 15、Cycle 2 (each cycle is 28 days) 、 Cycle 3 (each cycle is 28 days)、Cycle 4 (each cycle is 28 days)、、Cycle 5 (each cycle is 28 days)、Cycle 6 (each cycle is 28 days)
ORR (objective response rate) (Stage I)
Measured: every 8 weeks lasting about one year
BOR (best overall response) (Stage I)
Measured: every 8 weeks lasting about one year
DoR (duration of response) (Stage I)
Measured: every 8 weeks lasting about one year
CBR (clinical benefit rate) (Stage I)
Measured: every 8 weeks lasting about one year
PFS (progression-free survival) (Stage I)
Measured: every 8 weeks lasting about one year
(Serious) AEs (Stage II)
Measured: every week in Cycle 1 (28 days after the first dose), every 2 weeks in Cycle 2 (28 days after the second dose), every 4 weeks from Cycle 3 and thereafter (28 days after each dose), lasting about one year
Cmax, ss (Stage II)
Measured: Cycle 1 (each cycle is 28 days) day 15、Cycle 2 (each cycle is 28 days) 、 Cycle 3 (each cycle is 28 days) 、Cycle 4 (each cycle is 28 days)、、Cycle 5 (each cycle is 28 days)、Cycle 6 (each cycle is 28 days)
Tmax, ss (Stage II)
Measured: Cycle 1 (each cycle is 28 days) day 15、Cycle 2 (each cycle is 28 days) 、 Cycle 3 (each cycle is 28 days) 、Cycle 4 (each cycle is 28 days)、、Cycle 5 (each cycle is 28 days)、Cycle 6 (each cycle is 28 days)
Cmin, ss(Stage II)
Measured: Cycle 1 (each cycle is 28 days) day 15、Cycle 2 (each cycle is 28 days) 、 Cycle 3 (each cycle is 28 days) 、Cycle 4 (each cycle is 28 days)、、Cycle 5 (each cycle is 28 days)、Cycle 6 (each cycle is 28 days)
AUCss (Stage II)
Measured: Cycle 1 (each cycle is 28 days) day 15、Cycle 2 (each cycle is 28 days) 、 Cycle 3 (each cycle is 28 days) 、Cycle 4 (each cycle is 28 days)、、Cycle 5 (each cycle is 28 days)、Cycle 6 (each cycle is 28 days)
BOR (best overall response) (Stage II)
Measured: every 8 weeks lasting about one year
DoR (duration of response) (Stage II)
Measured: every 8 weeks lasting about one year
CBR (clinical benefit rate) (Stage II)
Measured: every 8 weeks lasting about one year
PFS (progression-free survival) (Stage II)
Measured: every 8 weeks lasting about one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2024
- Study start12 Aug 2024
- Primary completionDec 2027 (estimated)
- Study completionAug 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 CancerStudies of the same condition, open and under way.
- More trials run by Jiangsu HengRui 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- An open-label, multicenter, Phase Ib/II clinical study to evaluate the safety, tolerability, pharmacokinetics, and preliminary efficacy of HRS-6209 in combination with Other Antitumor Therapies in patients with breast cancer, or of HRS-9813 as monotherapy in patients with advanced solid tumors.
- Masking
- None (open label)
- Enrolment
- 528 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06555068
- Sponsor's protocol ID
- HRS-6209-201
- Status last verified
- Jul 2026
- First submitted
- 1 Aug 2024
- Last updated
- 22 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided