HR+ / HER2- Advanced Breast CancerPhase 1NCT07557004
A Study of SH3765 Tablets in Combination With Fulvestrant in Patients With HR+/HER2- Advanced Breast Cancer.
A Phase 1 study testing SH3765+Fulvestrant in people with HR+ / HER2- Advanced Breast Cancer, run by Nanjing Sanhome Pharmaceutical, Co., Ltd. at 1 site in China.
Trial summary
Evaluate the efficacy and safety of the SH3765 tablet combined with fulvestrant in the treatment of patients with advanced HR-positive breast cancer Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- HR+ / HER2- Advanced Breast Cancer
- What is being tested?
- SH3765+Fulvestrant
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 30 Sep 2025to 31 Dec 2027
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age≥18 years, female.
- Histologically confirmed HR-positive, HER2-negative (IHC 0, IHC 1+, or IHC 2+/ISH-) advanced breast cancer.
- Clear clinical or radiological evidence of disease progression or intolerance prior to enrollment.
- The patient has received one prior endocrine therapy regimen (as monotherapy or in combination, e.g., with a CDK4/6 inhibitor), and;a)has radiological evidence of breast cancer recurrence or progression during or within 12 months after completion of (neo)adjuvant endocrine therapy; or b) has radiological evidence of progression while receiving prior endocrine therapy as a line of treatment for locally advanced or metastatic breast cancer.
- The patient must meet at least one of the following definitions:
- Postmenopausal, defined as meeting at least one of the following criteria:a) age ≥ 60 years;b) age < 60 years with amenorrhea for ≥ 12 months, and follicle-stimulating hormone and plasma or serum estradiol levels within the postmenopausal range as assessed by the local laboratory, and no oral contraceptives, hormone replacement therapy, or gonadotropin-releasing hormone analogue administration within 12 months; c) prior bilateral oophorectomy.Premenopausal or perimenopausal (i.e., not meeting postmenopausal criteria) and meeting the following criterion: receiving luteinizing hormone-releasing hormone (LHRH) agonist therapy (e.g., goserelin or leuprorelin) starting at least 2 weeks prior to Cycle 1 Day 1 and continuing throughout the study treatment period.
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- At least one measurable lesion according to RECIST version 1.1 (measurable as defined in Appendix 1; target lesions cannot be from the brain). If the subject has only one measurable lesion at baseline, that lesion must not have been previously irradiated, or there must be evidence of clear progression of the lesion after completion of radiotherapy.
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 1.
- Life expectancy ≥12 weeks.
- Bone marrow function meets the following requirements (without receiving blood transfusion, erythropoietin (EPO), thrombopoietin (TPO), granulocyte colony-stimulating factor (G-CSF), granulocyte-macrophage colony-stimulating factor (GM-CSF), interleukin-11 (IL-11), or other corrective medications within 14 days prior to the first dose): absolute neutrophil count (ANC)≥1.5×10^9/L, platelet count (PLT)≥100×10^9/L, hemoglobin (Hb)≥90 g/L.
- Liver and kidney function are essentially normal, including: total bilirubin (TBIL)≤1.5×upper limit of normal (ULN) (for subjects with Gilbert's syndrome, hepatocellular carcinoma, or liver metastases, TBIL≤3×ULN); alanine aminotransferase (ALT) and aspartate aminotransferase (AST)≤2.5×ULN (for subjects with hepatocellular carcinoma or liver metastases, ALT and AST≤5×ULN); creatinine clearance (CLcr)≥50 mL/min (calculated using the Cockcroft-Gault formula, see Appendix 7).
- Coagulation function meets the following criteria: prothrombin time (PT) , activated partial thromboplastin time (APTT) and international normalized ratio (INR)≤1.5×ULN.
- Female subjects of childbearing potential must have a negative pregnancy test within 7 days prior to the start of treatment. If a subject has a positive serum pregnancy test, non-pregnant status must be confirmed. Premenopausal patients who have undergone ovarian suppression via LHRH agonist should agree to use effective contraception to avoid pregnancy during the study period and for 2 years after the last dose of fulvestrant.
- The subject is fully informed about this trial before its commencement and voluntarily signs and dates the informed consent form.
Who cannot join
- （1）Prior treatment with an anti-tumor agent targeting PRMT5, or prior treatment with fulvestrant.
- Received more than one line of chemotherapy for inoperable locally advanced or metastatic disease. Neoadjuvant and adjuvant chemotherapy are not considered lines of chemotherapy for advanced breast cancer.
- Received anti-tumor therapies including chemotherapy or immunotherapy within 3 weeks prior to the first study drug administration, except for the following: mitomycin and nitrosoureas within 6 weeks prior to the first study drug administration; oral fluoropyrimidines (e.g., S-1, capecitabine) within 2 weeks prior to the first study drug administration. Received radiotherapy, small-molecule targeted therapy, immunotherapy, or endocrine therapy within 2 weeks prior to the first study drug administration. Use of traditional Chinese medicines/herbal medicines with anti-cancer activity as described in their labeling is permitted prior to study entry, provided such agents are discontinued before initiation of study treatment.
- Received other unmarketed investigational medicinal products or treatments within 4 weeks prior to the first study drug administration, or is concurrently participating in another clinical study, except where the patient is enrolled in an observational, non-interventional clinical study, or is in the follow-up phase after completion of treatment in an interventional clinical study.
- Underwent major organ surgical procedures (excluding needle biopsy) within 28 days prior to the first study drug administration, experienced significant traumatic injury, or requires elective surgery during the trial period.
- Received a live vaccine (including live attenuated vaccines) within 28 days prior to the first study drug administration.
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- Use of systemic glucocorticoids (prednisone >10 mg/day or equivalent dose of other glucocorticoids) or other immunosuppressive agents within 14 days prior to study drug administration, except for the following: topical, ocular, intra-articular, intranasal, or inhaled glucocorticoids; short-term use of glucocorticoids for prophylactic purposes (e.g., prevention of contrast agent allergy).
- (8)Have received medications known to prolong the QT interval (see Appendix 4 for details) within 14 days or 5 half-lives (whichever is longer) prior to study drug administration.
- Receipt of medications known as strong inhibitors or inducers of CYP3A4, or inhibitors of P-gp (see Appendices 5 and 6 for details) within 7 days prior to study drug administration.
- (10)Presence of brain metastases, except for subjects with stable brain metastases, defined as follows: imaging evidence of stable or reduced lesions after local treatment, or clinical signs and symptoms stable for at least 4 weeks.
- (11)Any clinical evidence suggesting severe or uncontrolled systemic diseases, including but not limited to: active bleeding diathesis; uncontrolled pleural effusion or ascites; uncontrolled diabetes mellitus; other severe psychiatric, neurological, cardiovascular, or respiratory system diseases.
- (12)Presence of severe cardiovascular diseases, including but not limited to: ventricular arrhythmias requiring clinical intervention; acute coronary syndrome, congestive heart failure, stroke, or other Grade 3 or higher cardiovascular events within 6 months; New York Heart Association (NYHA) Functional Classification ≥ Class II (see Appendix 3 for details) or left ventricular ejection fraction (LVEF) <50%; clinically significant QTcF prolongation (male QTcF >450 msec or female QTcF >470 msec); clinically uncontrolled hypertension (defined in this protocol as systolic blood pressure >160 mmHg and/or diastolic blood pressure >100 mmHg despite optimal antihypertensive therapy), and deemed by the investigator as unsuitable for participation in the study.
- (13)An active infection requiring systemic anti-infective therapy is present within 1 week prior to study drug administration and has not resolved, unless, in the investigator's judgment, conditions such as fever due to the tumor do not interfere with study drug administration, in which case the subject may be enrolled.
- (14)The subject has hepatitis B virus (HBV), hepatitis C virus (HCV), or human immunodeficiency virus (HIV) infection. Antiviral therapy (excluding interferon) is permitted. Subjects with HBsAg positive but HBV-DNA ≤ the upper limit of normal (ULN) of the assay, or HCV antibody positive but HCV-RNA ≤ ULN of the assay, or HIV antibody positive but HIV-RNA ≤ ULN of the assay and with a normal CD4+ T cell count may be enrolled.
- (15)A previous or current history of other types of malignancies is exclusionary, except under the following circumstances: (i) cured cervical carcinoma in situ or non-melanoma skin cancer; (ii) a second primary cancer that has been curatively treated with no recurrence for five years; (iii) the investigator expects that both primary cancers may benefit from this study; (iv) the investigator has clearly determined the origin of the metastatic lesion as a specific primary tumor.
- (16)Receipt of an autologous hematopoietic stem cell transplant within 90 days prior to study drug administration is exclusionary.
- Subjets who had receive allogeneic hematopoietic stem cell transplantation or solid organ transplantation (except corneal transplant).
- According to CTCAE 5.0, adverse reactions from previous anti-tumor therapy have not yet returned to ≤ grade 1 (except for toxicities which are judged by researchers to be safe, such as hair loss).
- Occurrence of any CTCAE Grade 3 or 4 gastrointestinal bleeding within 3 months prior to study drug administration.
- Presence of poorly controlled nausea and vomiting, chronic gastrointestinal disease, inability to swallow the study drug formulation, or prior extensive bowel resection that may interfere with adequate absorption of the investigational product.
- History of hypersensitivity to the same class of the investigational drug or to its excipients (microcrystalline cellulose, lactose, croscarmellose sodium, magnesium stearate).
- Pregnant or lactating women. (23) Known alcohol and/or drug dependence, or any other condition deemed by the investigator to affect the safety or compliance of the study treatment.
Trial locations and contacts
1 site in 1 country.
China1 site
The First Affiliated Hospital Of USTC Anhui Provincial Hospital
Hefei, Anhui
About this study
Official title: A Phase Ib Clinical Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of SH3765 Tablets in Combination With Fulvestrant in Patients With Hormone Receptor-Positive, Human Epidermal Growth Factor Receptor 2-Negative (HR+/HER2-) Advanced Breast Cancer
Evaluate the efficacy and safety of the SH3765 tablet combined with fulvestrant in the treatment of patients with advanced HR-positive breast cancer
Read the detailed description
Based on the data obtained from the dose-escalation phase of the Phase I clinical trial, the safety profile of each dose cohort will be determined. The efficacy, safety, and pharmacokinetic characteristics will be further evaluated during the dose-expansion phase, thereby providing a basis for establishing the recommended dose for subsequent clinical trials.
- Conditions
- HR+ / HER2- Advanced Breast Cancer
- Being tested
- SH3765+Fulvestrant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SH3765+FulvestrantDrug
Drug1: SH3765 will be administered orally twice daily on an intermittent dosing schedule with treatment on Days 1 to 4 each week of a 28-day treatment cycle. The dosage is 40 mg or 60mg twice daily (BID) (4 days on and 3 days off).
Drug2：Fulvestrant injection is to be administered after taking the SH3765 tablets. It is given intramuscularly at a dose of 500 mg on Day 1 and Day 15 of Cycle 1, and then on Day 1 of each subsequent 28-day cycle.
| Study group | Role | What they receive |
|---|---|---|
| SH3765+fulvestrant | Experimental | SH3765（40mg BID）/SH3765（60mg BID）+ fulvestrant Receives: Drug: SH3765+Fulvestrant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Dose Limiting Toxicities (DLTs)
Measured: Days 1-28
Maximum tolerated dose (MTD)
Measured: Days 1-28
Secondary outcomes (8)
Time of Maximum Concentration (Tmax)
Measured: At pre-defined intervals from initial dose through final study visit (up to 24 months)
Maximum Concentration (Cmax)
Measured: At pre-defined intervals from initial dose through final study visit (up to 24 months)]
t1/2
Measured: At pre-defined intervals from initial dose through final study visit (up to 24 months)]
AUC0-24h
Measured: At pre-defined intervals from initial dose through final study visit (up to 24 months)
Objective Response Rate (ORR)
ORR was assessed by investigators per RECIST 1.1
Measured: up to 2 years
Disease control rate (DCR)
Disease control rate (DCR), which is defined as the proportion of subjects with complete response (CR), partial response (PR), or stable disease (SD), based on RECIST v1.1
Measured: up to 2 years
Progression-free survival (PFS)
From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first
Measured: up to 2 years
Duration of response (DoR)
DoR which is defined as the duration from the first documentation of objective response to the first documented disease progression or death due to any cause, whichever occurs first
Measured: up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2026
- Study start30 Sep 2025
- Primary completion30 Jun 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HR+ / HER2- Advanced Breast CancerStudies of the same condition, open and under way.
- 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
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nanjing Sanhome Pharmaceutical, Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07557004
- Sponsor's protocol ID
- SHC039-I-02
- Status last verified
- Apr 2026
- First submitted
- 15 Apr 2026
- Last updated
- 29 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase Ib Clinical Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of SH3765 Tablets in Combination With Fulvestrant in Patients With Hormone Receptor-Positive, Human Epidermal Growth Factor Receptor 2-Negative (HR+/HER2-) Advanced Breast Cancer
- ClinicalTrials.gov ID
- NCT07557004
- Acronym / sponsor ID
- SHC039-I-02
- Conditions
- HR+ / HER2- Advanced Breast Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Nanjing Sanhome Pharmaceutical, Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 30 Sep 2025 (actual)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 29 Apr 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.
Evaluate the efficacy and safety of the SH3765 tablet combined with fulvestrant in the treatment of patients with advanced HR-positive breast cancer
Detailed description
Based on the data obtained from the dose-escalation phase of the Phase I clinical trial, the safety profile of each dose cohort will be determined. The efficacy, safety, and pharmacokinetic characteristics will be further evaluated during the dose-expansion phase, thereby providing a basis for establishing the recommended dose for subsequent clinical trials.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SH3765+fulvestrant | Experimental | Drug: SH3765+FulvestrantSH3765（40mg BID）/SH3765（60mg BID）+ fulvestrant |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Age≥18 years, female.
- Histologically confirmed HR-positive, HER2-negative (IHC 0, IHC 1+, or IHC 2+/ISH-) advanced breast cancer.
- Clear clinical or radiological evidence of disease progression or intolerance prior to enrollment.
- The patient has received one prior endocrine therapy regimen (as monotherapy or in combination, e.g., with a CDK4/6 inhibitor), and;a)has radiological evidence of breast cancer recurrence or progression during or within 12 months after completion of (neo)adjuvant endocrine therapy; or b) has radiological evidence of progression while receiving prior endocrine therapy as a line of treatment for locally advanced or metastatic breast cancer.
- The patient must meet at least one of the following definitions:
Key exclusion criteria (22 listed)
- （1）Prior treatment with an anti-tumor agent targeting PRMT5, or prior treatment with fulvestrant.
- Received more than one line of chemotherapy for inoperable locally advanced or metastatic disease. Neoadjuvant and adjuvant chemotherapy are not considered lines of chemotherapy for advanced breast cancer.
- Received anti-tumor therapies including chemotherapy or immunotherapy within 3 weeks prior to the first study drug administration, except for the following: mitomycin and nitrosoureas within 6 weeks prior to the first study drug administration; oral fluoropyrimidines (e.g., S-1, capecitabine) within 2 weeks prior to the first study drug administration. Received radiotherapy, small-molecule targeted therapy, immunotherapy, or endocrine therapy within 2 weeks prior to the first study drug administration. Use of traditional Chinese medicines/herbal medicines with anti-cancer activity as described in their labeling is permitted prior to study entry, provided such agents are discontinued before initiation of study treatment.
- Received other unmarketed investigational medicinal products or treatments within 4 weeks prior to the first study drug administration, or is concurrently participating in another clinical study, except where the patient is enrolled in an observational, non-interventional clinical study, or is in the follow-up phase after completion of treatment in an interventional clinical study.
- Underwent major organ surgical procedures (excluding needle biopsy) within 28 days prior to the first study drug administration, experienced significant traumatic injury, or requires elective surgery during the trial period.
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 |
|---|---|---|
| SH3765+FulvestrantDrug1: SH3765 will be administered orally twice daily on an intermittent dosing schedule with treatment on Days 1 to 4 each week of a 28-day treatment cycle. The dosage is 40 mg or 60mg twice daily (BID) (4 days on and 3 days off). Drug2：Fulvestrant injection is to be administered after taking the SH3765 tablets. It is given intramuscularly at a dose of 500 mg on Day 1 and Day 15 of Cycle 1, and then on Day 1 of each subsequent 28-day cycle. | Drug | SH3765+fulvestrant |
Primary outcome
Number of Participants With Dose Limiting Toxicities (DLTs)
Time frame: Days 1-28
Maximum tolerated dose (MTD)
Time frame: Days 1-28
8 secondary outcomes
Time of Maximum Concentration (Tmax)
Time frame: At pre-defined intervals from initial dose through final study visit (up to 24 months)
Maximum Concentration (Cmax)
Time frame: At pre-defined intervals from initial dose through final study visit (up to 24 months)]
t1/2
Time frame: At pre-defined intervals from initial dose through final study visit (up to 24 months)]
AUC0-24h
Time frame: At pre-defined intervals from initial dose through final study visit (up to 24 months)
Objective Response Rate (ORR)
Time frame: up to 2 years
Disease control rate (DCR)
Time frame: up to 2 years
Progression-free survival (PFS)
Time frame: up to 2 years
Duration of response (DoR)
Time frame: up to 2 years
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 29 Apr 2026.
- Individual participant dataSharing planned: No
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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 SH3765+Fulvestrant in people with HR+ / HER2- Advanced Breast Cancer, run by Nanjing Sanhome 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 14 inclusion and 22 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 29 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 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?
Number of Participants With Dose Limiting Toxicities (DLTs) (time frame: Days 1-28). The study lists 2 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 29 Apr 2026.