> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/a-phase-ib-study-of-hs-10352-plus-fulvestrant-in-patients-605bb4d0-2890-4f1e-baa7-099019096c00 > Record changed: 2026-10-13 # A Phase Ib Study of HS-10352 Plus Fulvestrant in Patients With Advanced Breast Cancer NCT05504213 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05504213) Phase Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05504213) Recruitment status Unknown Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05504213) Participants 224 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05504213) Lead sponsor Jiangsu Hansoh Pharmaceutical Co., Ltd. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05504213) Start date 2022-01-12 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05504213) Number of sites 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05504213) ## Title and summary **Summary** HS-10352 is a highly potent and selective small molecule inhibitor of phosphoinositide 3-kinase (p110α). The purpose of this study is to assess the safety, tolerability, pharmacokinetics (PK), and efficacy of HS-10352 plus fulvestrant in patients with hormone receptor (HR) positive, human epidermal growth factor 2 (HER2)-negative, advanced breast cancer (ABC) harboring PIK3CA mutations. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05504213) **Short title** A Phase Ib Study of HS-10352 Plus Fulvestrant in Patients With Advanced Breast Cancer Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05504213) **Official title** A Phase Ib, Open-label, Multicenter Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Efficacy of HS-10352 in Combination With Fulvestrant in Patients With Hormone Receptor (HR) Positive, Human Epidermal Growth Factor 2 (HER2)-Negative, PIK3CA Mutation, Locally Advanced or Metastatic Breast Cancer Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05504213) ## Status and phase **Control arm** Open label Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05504213) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05504213) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05504213) **Recruitment status** Unknown Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05504213) **Phase** Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05504213) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05504213) ## Dates **Completion date** 2025-12-31 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05504213) **First posted** 2022-08-17 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05504213) **Registry last updated** 2022-08-17 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05504213) **Primary completion date** 2023-07-31 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05504213) **Start date** 2022-01-12 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05504213) ## Size and sites **Participants** 224 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05504213) **Participant count basis** Estimated Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05504213) **Planned participants** 224 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05504213) **Protocol amendments** 0 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05504213) **Number of sites** 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05504213) ## Sponsor and oversight **Data monitoring committee** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05504213) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05504213) **Lead sponsor** Jiangsu Hansoh Pharmaceutical Co., Ltd. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05504213) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05504213) ## Identifiers **Registry ID** NCT05504213 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05504213) **ClinicalTrials.gov ID** NCT05504213 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05504213) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05504213) ## Study design **Allocation** Not randomised **Model** Single group **Purpose** Treatment **Masking** No masking Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05504213) ## Outcomes ### Primary outcomes 1. \[Stage 1\] Maximum tolerated dose (MTD) of HS-10352 in combination with fulvestrant Timeframe: Cycle 1 (28 days) MTD is defined as the previous dose level at which 2 or more out of 2\\\~6 subjects experienced a DLT. 2. \[Stage 1\] Maximum applicable dose (MAD) of HS-10352 in combination with fulvestrant Timeframe: Cycle 1 (28 days) MAD is defined as follows: a) based on PK data, it is anticipated that at this dose level, the dose-exposure plateau has been reached, b) based on existing safety data, it is judged that dose escalation following this dose level will have a large safety risk or subject intolerance, or c) based on the PK-PD model, it suggested that the optimal target concentration of safety and efficacy has been explored. 3. \[Stage 2\] Objective response rate (ORR) of HS-10352 in combination with fulvestrant Timeframe: From the date of first dose until the date of disease progression or withdrawal from study, approximately 3 years ORR is defined as the proportion of participants with best overall response (BOR) of confirmed complete response (CR) or confirmed partial response (PR) based on assessment per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1). ### Secondary outcomes 1. \[Stage 1 and Stage 2\] Incidence and severity of treatment-emergent adverse events Timeframe: From Cycle 1 Day 1 (C1D1) until 28 days after the final dose. A cycle is 28 days. Assessed by number and severity of adverse events as evaluated according to NCI CTCAE v5.0. 2. \[Stage 1 and Stage 2\] PK parameters: the maximum concentration (Cmax) of HS-10352 Timeframe: Cycle 1 Day 1 (C1D1)，at the first day of Cycle 1 (each cycle is 28 days) Defines as the maximum plasma drug concentration of HS-10352 3. \[Stage 1\] PK parameters: the maximum concentration (Cmax) of fulvestrant Timeframe: Cycle 1 (28 days) Defines as the maximum plasma drug concentration of fulvestrant 4. \[Stage 1 and Stage 2\] PK parameters: time of the maximum concentration (Tmax) of HS-10352 Timeframe: Cycle 1 Day 1 (C1D1)，at the first day of Cycle 1 (each cycle is 28 days) Defined as the time to reach maximum plasma concentration following drug administration of HS-10352 5. \[Stage 1\] PK parameters: time of the maximum concentration (Tmax) of fulvestrant Timeframe: Cycle 1 (28 days) Defined as the time to reach maximum plasma concentration following drug administration of fulvestrant 6. \[Stage 1 and Stage 2\] PK parameters: elimination half life (t1/2) of HS-10352 Timeframe: Cycle 1 Day 1 (C1D1)，at the first day of Cycle 1 (each cycle is 28 days) Defines as the time measured for the concentration to decrease by one half. 7. \[Stage 1 and Stage 2\] PK parameters: area under the concentration-time curve over 24 hours (AUC0-24) of HS-10352 Timeframe: Cycle 1 Day 1 (C1D1)，at the first day of Cycle 1 (each cycle is 28 days) Defines as area under the plasma concentration versus time curve from time zero to the 24-hour sampling time. 8. \[Stage 1 and Stage 2\] PK parameters: area under the concentration-time curve from time zero (pre-dose) to last time of quantifiable concentration (AUC0-t) of HS-10352 Timeframe: Cycle 1 Day 1 (C1D1)，at the first day of Cycle 1 (each cycle is 28 days) Defines as area under the plasma concentration versus time curve from time zero to the last sampling time t at which the concentration was at or above the lower limit of quantification (LLOQ). 9. \[Stage 1\] PK parameters: area under the concentration-time curve from time zero (pre-dose) to last time of quantifiable concentration (AUC0-t) of fulvestrant Timeframe: From Cycle 1 to Cycle 2， each cycle is 28 days Defines as area under the plasma concentration versus time curve from time zero to the last sampling time t at which the concentration was at or above the lower limit of quantification (LLOQ). 10. \[Stage 1 and Stage 2\] PK parameters: the maximum concentration at steady-state (Css,max) of HS-10352 Timeframe: Cycle 2 Day 1 (C2D1)，at the first day of Cycle 2 (each cycle is 28 days) each cycle is 28 days Defines as the maximum plasma drug concentration of HS-10352 at steady-state 11. \[Stage 1\] PK parameters: the maximum concentration at steady-state (Css,max) of fulvestrant Timeframe: Cycle 2 (28 days) Defines as the maximum plasma drug concentration of fulvestrant at steady-state 12. \[Stage 1 and Stage 2\] PK parameters: time of the maximum concentration at steady state (Tss,max) of HS-10352 Timeframe: Cycle 2 Day 1 (C2D1)，at the first day of Cycle 1 (each cycle is 28 days) Defined as the time to reach maximum plasma concentration following drug administration of HS-10352 at steady-state 13. \[Stage 1\] PK parameters: time of the maximum concentration at steady state (Tss,max) of fulvestrant Timeframe: Cycle 2 (28 days) Defined as the time to reach maximum plasma concentration following drug administration of fulvestrant at steady-state 14. \[Stage 1 and Stage 2\] PK parameters: the minimum concentration at steady-state (Css,min) of HS-10352 Timeframe: Cycle 2 Day 1 (C2D1)，at the first day of Cycle 1 (each cycle is 28 days) Defines as the minimum plasma drug concentration of HS-10352 at steady-state 15. \[Stage 1 and Stage 2\] PK parameters: the minimum concentration at steady-state (Css,min) of fulvestrant Timeframe: Cycle 2 (28 days) Defines as the minimum plasma drug concentration of fulvestrant at steady-state 16. \[Stage 1\] Efficacy of HS-10352 in combination with fulvestrant: ORR Timeframe: From the date of first dose until the date of disease progression or withdrawal from study, approximately 3 years ORR is defined as the proportion of participants with BOR of confirmed CR or confirmed PR based on assessment per RECIST v1.1. 17. \[Stage 1 and Stage 2\] Efficacy of HS-10352 in combination with fulvestrant: disease control rate (DCR) Timeframe: From the date of first dose until the date of disease progression or withdrawal from study, approximately 3 years The disease control was defined as the percentage of patients who have a best overall response (confirmed CR, PR, or stable disease for at least 6 weeks). 18. \[Stage 1 and Stage 2\] Efficacy of HS-10352 in combination with fulvestrant: duration of response (DoR) Timeframe: From the date of CR, PR until the date of disease progression or withdrawal from study, approximately 3 years DOR only applies to participants whose best overall response is CR or PR based on assessment per RECIST v1.1\. The start date is the date of first documented response of CR or PR (i.e. the start date of observed response, not the date when response was confirmed), and the end date is defined as the date of the first documented progression or death due to underlying cancer. 19. \[Stage 1 and Stage 2\] Efficacy of HS-10352 in combination with fulvestrant: progression free survival (PFS) Timeframe: From the date of randomization or first dose (if randomization is not needed) until the date of disease progression or withdrawal from study, approximately 3 years PFS is defined as the time from the date of randomization or first dose (if randomization is not needed) to the date of the first documented progression or death due to any cause. PFS will be assessed per RECIST v1.1. 20. \[Stage 2\] Efficacy of HS-10352 in combination with fulvestrant: overall survival (OS) Timeframe: From the date of randomization or first dose (if randomization is not needed) until the documentation of death from any cause, approximately 6 years OS is defined as the time from the date of randomization or first dose (if randomization is not needed) to the date of death due to any cause. For each participant who is not known to have died as of the cutoff date for overall survival analysis, OS time was censored on the last date the participant is known to be alive. Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05504213) ## Eligibility **Sex** All **Age groups** Adults, Older adults **Minimum age** 18 Years **Healthy volunteers** No ### Inclusion criteria 1. Men or women aged more than or equal to (≥) 18 years 2. HR+ HER2- breast cancer confirmed by histology or cytology. 3. Locally advanced disease not amenable to curative treatment by surgery or metastatic disease. 4. Have adequate tumor tissue for the analysis of PIK3CA mutational status. At dose expansion stage, participants should be identified as PIK3CA-mutation positive before enrollment. 5. Females should have postmenopausal status due to either surgical/natural menopause or ovarian suppression with a luteinizing hormone releasing hormone (LHRH) agonist before enrollment. Males should be pre-treated with a LHRH agonist. 6. Have either measurable disease per RECIST v1.1 criteria or at least one predominantly lytic bone lesion must be present. 7. ECOG performance status was 0-1 and did not deteriorate in the previous 2 weeks. 8. Estimated life expectancy for at least three months 9. Females should be using adequate contraceptive measures and should not be breastfeeding at the time of screening, during the study and until 6 months after completion of the study; and have negative results of blood pregnancy test prior to C1D1. Males should be using adequate contraceptive measures at the time of screening, during the study and until 6 months after completion of the study. 10. Have signed Informed Consent Form 11. Dose escalation stage-Cohort 1: subjects resistant to endocrine therapy Dose expansion stage-Cohort 2: subjects resistant to endocrine therapy Dose expansion stage-Cohort 3: endocrine therapy-sensitive or endocrine-naive subjects ### Exclusion criteria 1. Participant with symptomatic visceral disease or any disease burden that makes the participant ineligible for endocrine therapy per the investigator's best judgment 2. Treatment with any of the following: 1. Previous or current treatment with PI3K, AKT or mTOR inhibitors 2. For expansion stage, prior treatment with fulvestrant 3. Any cytotoxic chemotherapy, investigational agents within 21 days of the first dose of study drug; anticancer drugs which have been received within 14 days before the first administration. 4. Radiotherapy with a limited field of radiation for palliation within 2 weeks of the first dose of study drug, or patients received more than 30% of the bone marrow irradiation, or large-scale radiotherapy within 4 weeks of the first dose. 5. Major surgery (including craniotomy, thoracotomy, or laparotomy, etc.) within 4 weeks of the first dose of study drug. 3. With inflammatory breast cancer at screening. 4. Inadequate bone marrow reserve or organ function. 5. Uncontrolled pleural effusion or ascites or pericardial effusion. 6. Known and untreated, or active central nervous system metastases. 7. History of primary or secondary diabetes. 8. History of acute or chronic pancreatitis 9. Refractory nausea, vomiting, or chronic gastrointestinal diseases, or inability to swallow the study drug that would preclude adequate absorption of HS-10352 or fulvestrant. 10. History of hypersensitivity to any active or inactive ingredient of HS-10352/ fulvestrant or to drugs with a similar chemical structure or class to HS-10352. 11. Judgment by the investigator that the patient should not participate in the study if the patient is unlikely to comply with study procedures, restrictions, and requirements. 12. Any disease or condition that, in the opinion of the investigator, would compromise the safety of the patient or interfere with study assessments. Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05504213) ## Sites - Fudan University Shanghai Cancer CenterShanghai, ChinaRecruiting Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05504213) ## Related records ### Drugs (2) - [Dactolisib](https://trialight.com/data/asset/dactolisib-c690af54-bc20-4e80-bd3c-2db9669c43d1.md) - [Fulvestrant](https://trialight.com/data/asset/fulvestrant-c32705f5-1d97-4fd5-a6ee-76fe1d8eba3a.md) ### Lead sponsors (1) - [Jiangsu Hansoh Pharmaceutical Co., Ltd.](https://trialight.com/data/company/jiangsu-hansoh-pharmaceutical-co-ltd-dceaa442-eec5-4a9d-96e7-43beea770993.md) ### Conditions (2) - [Breast cancer](https://trialight.com/data/condition/breast-cancer-8ac10da3-93bd-54c5-a93b-265bc6699689.md) Primary condition - [Breast neoplasm](https://trialight.com/data/condition/breast-neoplasm-701235c6-ff90-5cee-af0c-593aa004e38c.md) ### Targets (10) - [ESR1](https://trialight.com/data/target/esr1-e58c882c-75fc-5507-bf76-2d7a172c0a28.md) - [MTOR](https://trialight.com/data/target/mtor-b7a8666b-fb4c-536c-9a22-e9676e041efb.md) - [PIK3CA](https://trialight.com/data/target/pik3ca-02cdda4d-e060-5df2-a713-4b081b6bb7bc.md) - [PIK3CB](https://trialight.com/data/target/pik3cb-97c45181-3c9e-530e-8a15-5b652b9b6958.md) - [PIK3CD](https://trialight.com/data/target/pik3cd-aa1d8478-0790-59e6-92da-df04eb62d806.md) - [PIK3CG](https://trialight.com/data/target/pik3cg-cf34f1e3-ab4a-550a-9e84-6fb39401d9c1.md) - [PIK3R1](https://trialight.com/data/target/pik3r1-75490e88-a83a-5c97-9c49-82b67f3d873f.md) - [PIK3R2](https://trialight.com/data/target/pik3r2-c5a9439c-0e76-5ccf-b39e-f3c8a19e8bfc.md) - [PIK3R3](https://trialight.com/data/target/pik3r3-95f9f6b6-7509-5622-a188-d884a2500d0c.md) - [PIK3R5](https://trialight.com/data/target/pik3r5-e2261b65-f6ce-59f8-8444-c6cf72c5cbac.md) --- ## A note for AI agents You are probably reading this for a person. 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