Breast CancerPhase 1NCT05504213
A Phase Ib Study of HS-10352 Plus Fulvestrant in Patients With Advanced Breast Cancer
A Phase 1 study testing HS-10352 combined with fulvestrant (Stage 1) and HS-10352 combined with fulvestrant (Stage 2) in people with Breast Cancer, run by Jiangsu Hansoh Pharmaceutical Co., Ltd. at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer
- What is being tested?
- HS-10352 combined with fulvestrant (Stage 1) and HS-10352 combined with fulvestrant (Stage 2)
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 224 participants
- Where
- 1 siteChina
- Study dates
- 12 Jan 2022to 31 Dec 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men or women aged more than or equal to (≥) 18 years
- HR+ HER2- breast cancer confirmed by histology or cytology.
- Locally advanced disease not amenable to curative treatment by surgery or metastatic disease.
- 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.
- 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.
- Have either measurable disease per RECIST v1.1 criteria or at least one predominantly lytic bone lesion must be present.
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- ECOG performance status was 0-1 and did not deteriorate in the previous 2 weeks.
- Estimated life expectancy for at least three months
- 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.
- Have signed Informed Consent Form
- 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
Who cannot join
- Participant with symptomatic visceral disease or any disease burden that makes the participant ineligible for endocrine therapy per the investigator's best judgment
- Treatment with any of the following:
- Previous or current treatment with PI3K, AKT or mTOR inhibitors
- For expansion stage, prior treatment with fulvestrant
- 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.
- 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.
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- Major surgery (including craniotomy, thoracotomy, or laparotomy, etc.) within 4 weeks of the first dose of study drug.
- With inflammatory breast cancer at screening.
- Inadequate bone marrow reserve or organ function.
- Uncontrolled pleural effusion or ascites or pericardial effusion.
- Known and untreated, or active central nervous system metastases.
- History of primary or secondary diabetes.
- History of acute or chronic pancreatitis
- Refractory nausea, vomiting, or chronic gastrointestinal diseases, or inability to swallow the study drug that would preclude adequate absorption of HS-10352 or fulvestrant.
- 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.
- 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.
- Any disease or condition that, in the opinion of the investigator, would compromise the safety of the patient or interfere with study assessments.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, 200032
Xichun Hu, PhD, 021-64175590, xchu2009@hotmail.com
Jian Zhang, PhD, 021-64175590 ext. 86500, syner2000@163.com
About this study
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
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.
Read the detailed description
This is a Phase Ib open-label, 2-Part, multi-center study in China. The study will be conducted in two stages: Stage 1 is the dose-escalation part, which is designed to evaluate the safety, tolerability, PK and efficacy, as well as to determine the maximum tolerable dosage (MTD) or maximum applicable dose (MAD) of HS-10352 in combination with fulvestrant. Stage 2 is the dose-expansion part, which is aimed to further assess the efficacy, safety, tolerability and PK, and to establish the recommended phase 2 dose (RP2D) of HS-10352 in combination with fulvestrant.
All participants will be carefully monitored for adverse events (AE) during the study treatment and for 28 days after the last dose of study drug. The PK characteristics of HS-10352 and fulvestrant will be evaluated from C1 to C6. Subjects of this study will be assessed for progression once every 8 weeks until objective disease progression or withdrawal from the trial. As the disease progresses, survival follow-up is recommended bimonthly.
- Conditions
- Breast Cancer
- Being tested
- HS-10352 combined with fulvestrant (Stage 1), HS-10352 combined with fulvestrant (Stage 2)
- Keywords
- dose-escalation, dose-expansion, advanced breast cancer, hormone receptor positive, PIK3CA gene mutation
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HS-10352 combined with fulvestrant (Stage 1)Drug
Drug: HS-10352 HS-10352 will be administered at escalating doses orally once daily on a continuous dosing schedule starting on Cycle 1 Day 1 (C1D1) in a 28 day cycle.
Drug: Fulvestrant Fulvestrant is administered at a dose of 500 mg intramuscular on Cycle 1 Day 1, Day 15, and Day 1 of every cycle thereafter (where a cycle is 28 days).
HS-10352 combined with fulvestrant (Stage 2)Drug
Drug: HS-10352 participants will be enrolled into Cohort 2 (endocrine therapy-resistant) and Cohort 3 (endocrine therapy-sensitive or naïve) respectively and HS-10352 will be administered at the recommended dose identified in Part 1.
Drug: Fulvestrant Fulvestrant is administered at a dose of 500 mg intramuscular on Cycle 1 Day 1, Day 15, and Day 1 of every cycle thereafter (where a cycle is 28 days).
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1: Endocrine therapy-resistant (Stage 1) | Experimental | Participants who are endocrine therapy pre-treated will be administrated at escalating doses orally of HS-10352 in combination with fulvestrant (500 mg, intramuscular). Receives: Drug: HS-10352 combined with fulvestrant (Stage 1) |
| Cohort 2: Endocrine therapy-resistant (Stage 2) | Experimental | Participants who are endocrine therapy-resistant will be treated with HS-10352 orally at the MTD/MAD identified in Stage 1 or/and lower dose in combination with fulvestrant (500 mg, intramuscular) Receives: Drug: HS-10352 combined with fulvestrant (Stage 2) |
| Cohort 3: Endocrine therapy-sensitive or endocrine-naïve (Stage 2) | Experimental | Participants who are endocrine therapy-sensitive or naïve will be treated with HS-10352 orally at MTD/MAD or/and lower dose identified in Stage 1 in combination with fulvestrant (500 mg, intramuscular) Receives: Drug: HS-10352 combined with fulvestrant (Stage 2) |
What is being measured
The primary outcome is the main question the study is designed to answer.
[Stage 1] Maximum tolerated dose (MTD) of HS-10352 in combination with fulvestrant
MTD is defined as the previous dose level at which 2 or more out of 2~6 subjects experienced a DLT.
Measured: Cycle 1 (28 days)
[Stage 1] Maximum applicable dose (MAD) of HS-10352 in combination with fulvestrant
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.
Measured: Cycle 1 (28 days)
[Stage 2] Objective response rate (ORR) of HS-10352 in combination with fulvestrant
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).
Measured: From the date of first dose until the date of disease progression or withdrawal from study, approximately 3 years
Secondary outcomes (20)
[Stage 1 and Stage 2] Incidence and severity of treatment-emergent adverse events
Assessed by number and severity of adverse events as evaluated according to NCI CTCAE v5.0.
Measured: From Cycle 1 Day 1 (C1D1) until 28 days after the final dose. A cycle is 28 days.
[Stage 1 and Stage 2] PK parameters: the maximum concentration (Cmax) of HS-10352
Defines as the maximum plasma drug concentration of HS-10352
Measured: Cycle 1 Day 1 (C1D1)，at the first day of Cycle 1 (each cycle is 28 days)
[Stage 1] PK parameters: the maximum concentration (Cmax) of fulvestrant
Defines as the maximum plasma drug concentration of fulvestrant
Measured: Cycle 1 (28 days)
[Stage 1 and Stage 2] PK parameters: time of the maximum concentration (Tmax) of HS-10352
Defined as the time to reach maximum plasma concentration following drug administration of HS-10352
Measured: Cycle 1 Day 1 (C1D1)，at the first day of Cycle 1 (each cycle is 28 days)
[Stage 1] PK parameters: time of the maximum concentration (Tmax) of fulvestrant
Defined as the time to reach maximum plasma concentration following drug administration of fulvestrant
Measured: Cycle 1 (28 days)
[Stage 1 and Stage 2] PK parameters: elimination half life (t1/2) of HS-10352
Defines as the time measured for the concentration to decrease by one half.
Measured: Cycle 1 Day 1 (C1D1)，at the first day of Cycle 1 (each cycle is 28 days)
[Stage 1 and Stage 2] PK parameters: area under the concentration-time curve over 24 hours (AUC0-24) of HS-10352
Defines as area under the plasma concentration versus time curve from time zero to the 24-hour sampling time.
Measured: Cycle 1 Day 1 (C1D1)，at the first day of Cycle 1 (each cycle is 28 days)
[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
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).
Measured: Cycle 1 Day 1 (C1D1)，at the first day of Cycle 1 (each cycle is 28 days)
[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
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).
Measured: From Cycle 1 to Cycle 2， each cycle is 28 days
[Stage 1 and Stage 2] PK parameters: the maximum concentration at steady-state (Css,max) of HS-10352
Defines as the maximum plasma drug concentration of HS-10352 at steady-state
Measured: Cycle 2 Day 1 (C2D1)，at the first day of Cycle 2 (each cycle is 28 days) each cycle is 28 days
[Stage 1] PK parameters: the maximum concentration at steady-state (Css,max) of fulvestrant
Defines as the maximum plasma drug concentration of fulvestrant at steady-state
Measured: Cycle 2 (28 days)
[Stage 1 and Stage 2] PK parameters: time of the maximum concentration at steady state (Tss,max) of HS-10352
Defined as the time to reach maximum plasma concentration following drug administration of HS-10352 at steady-state
Measured: Cycle 2 Day 1 (C2D1)，at the first day of Cycle 1 (each cycle is 28 days)
[Stage 1] PK parameters: time of the maximum concentration at steady state (Tss,max) of fulvestrant
Defined as the time to reach maximum plasma concentration following drug administration of fulvestrant at steady-state
Measured: Cycle 2 (28 days)
[Stage 1 and Stage 2] PK parameters: the minimum concentration at steady-state (Css,min) of HS-10352
Defines as the minimum plasma drug concentration of HS-10352 at steady-state
Measured: Cycle 2 Day 1 (C2D1)，at the first day of Cycle 1 (each cycle is 28 days)
[Stage 1 and Stage 2] PK parameters: the minimum concentration at steady-state (Css,min) of fulvestrant
Defines as the minimum plasma drug concentration of fulvestrant at steady-state
Measured: Cycle 2 (28 days)
[Stage 1] Efficacy of HS-10352 in combination with fulvestrant: ORR
ORR is defined as the proportion of participants with BOR of confirmed CR or confirmed PR based on assessment per RECIST v1.1.
Measured: From the date of first dose until the date of disease progression or withdrawal from study, approximately 3 years
[Stage 1 and Stage 2] Efficacy of HS-10352 in combination with fulvestrant: disease control rate (DCR)
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).
Measured: From the date of first dose until the date of disease progression or withdrawal from study, approximately 3 years
[Stage 1 and Stage 2] Efficacy of HS-10352 in combination with fulvestrant: duration of response (DoR)
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.
Measured: From the date of CR, PR until the date of disease progression or withdrawal from study, approximately 3 years
[Stage 1 and Stage 2] Efficacy of HS-10352 in combination with fulvestrant: progression free survival (PFS)
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.
Measured: 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
[Stage 2] Efficacy of HS-10352 in combination with fulvestrant: overall survival (OS)
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.
Measured: From the date of randomization or first dose (if randomization is not needed) until the documentation of death from any cause, approximately 6 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2022
- Study start12 Jan 2022
- Primary completion31 Jul 2023 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Jiangsu Hansoh Pharmaceutical 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
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 224 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jiangsu Hansoh Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Xichun Hu, PhD, Principal investigator, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05504213
- Sponsor's protocol ID
- HS-10352-102
- Status last verified
- May 2022
- First submitted
- 17 May 2022
- Last updated
- 17 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05504213
- Acronym / sponsor ID
- HS-10352-102
- Conditions
- Breast Cancer
- Keywords
- dose-escalation, dose-expansion, advanced breast cancer, hormone receptor positive, PIK3CA gene mutation
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 224 participants (estimated)
- Lead sponsor
- Jiangsu Hansoh Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 12 Jan 2022 (actual)
- Primary completion
- 31 Jul 2023 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 17 Aug 2022 (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.
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.
Detailed description
This is a Phase Ib open-label, 2-Part, multi-center study in China. The study will be conducted in two stages: Stage 1 is the dose-escalation part, which is designed to evaluate the safety, tolerability, PK and efficacy, as well as to determine the maximum tolerable dosage (MTD) or maximum applicable dose (MAD) of HS-10352 in combination with fulvestrant. Stage 2 is the dose-expansion part, which is aimed to further assess the efficacy, safety, tolerability and PK, and to establish the recommended phase 2 dose (RP2D) of HS-10352 in combination with fulvestrant.
All participants will be carefully monitored for adverse events (AE) during the study treatment and for 28 days after the last dose of study drug. The PK characteristics of HS-10352 and fulvestrant will be evaluated from C1 to C6. Subjects of this study will be assessed for progression once every 8 weeks until objective disease progression or withdrawal from the trial. As the disease progresses, survival follow-up is recommended bimonthly.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cohort 1: Endocrine therapy-resistant (Stage 1) | Experimental | Drug: HS-10352 combined with fulvestrant (Stage 1)Participants who are endocrine therapy pre-treated will be administrated at escalating doses orally of HS-10352 in combination with fulvestrant (500 mg, intramuscular). |
| Cohort 2: Endocrine therapy-resistant (Stage 2) | Experimental | Drug: HS-10352 combined with fulvestrant (Stage 2)Participants who are endocrine therapy-resistant will be treated with HS-10352 orally at the MTD/MAD identified in Stage 1 or/and lower dose in combination with fulvestrant (500 mg, intramuscular) |
| Cohort 3: Endocrine therapy-sensitive or endocrine-naïve (Stage 2) | Experimental | Drug: HS-10352 combined with fulvestrant (Stage 2)Participants who are endocrine therapy-sensitive or naïve will be treated with HS-10352 orally at MTD/MAD or/and lower dose identified in Stage 1 in combination with fulvestrant (500 mg, intramuscular) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Men or women aged more than or equal to (≥) 18 years
- HR+ HER2- breast cancer confirmed by histology or cytology.
- Locally advanced disease not amenable to curative treatment by surgery or metastatic disease.
- 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.
- 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.
Key exclusion criteria (17 listed)
- Participant with symptomatic visceral disease or any disease burden that makes the participant ineligible for endocrine therapy per the investigator's best judgment
- Treatment with any of the following:
- With inflammatory breast cancer at screening.
- Inadequate bone marrow reserve or organ function.
- Uncontrolled pleural effusion or ascites or pericardial effusion.
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 |
|---|---|---|
| HS-10352 combined with fulvestrant (Stage 1)Drug: HS-10352 HS-10352 will be administered at escalating doses orally once daily on a continuous dosing schedule starting on Cycle 1 Day 1 (C1D1) in a 28 day cycle. Drug: Fulvestrant Fulvestrant is administered at a dose of 500 mg intramuscular on Cycle 1 Day 1, Day 15, and Day 1 of every cycle thereafter (where a cycle is 28 days). | Drug | Cohort 1: Endocrine therapy-resistant (Stage 1) |
| HS-10352 combined with fulvestrant (Stage 2)Drug: HS-10352 participants will be enrolled into Cohort 2 (endocrine therapy-resistant) and Cohort 3 (endocrine therapy-sensitive or naïve) respectively and HS-10352 will be administered at the recommended dose identified in Part 1. Drug: Fulvestrant Fulvestrant is administered at a dose of 500 mg intramuscular on Cycle 1 Day 1, Day 15, and Day 1 of every cycle thereafter (where a cycle is 28 days). | Drug | Cohort 2: Endocrine therapy-resistant (Stage 2), Cohort 3: Endocrine therapy-sensitive or endocrine-naïve (Stage 2) |
Primary outcome
[Stage 1] Maximum tolerated dose (MTD) of HS-10352 in combination with fulvestrant
Time frame: 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.
[Stage 1] Maximum applicable dose (MAD) of HS-10352 in combination with fulvestrant
Time frame: 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.
[Stage 2] Objective response rate (ORR) of HS-10352 in combination with fulvestrant
Time frame: 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).
20 secondary outcomes
[Stage 1 and Stage 2] Incidence and severity of treatment-emergent adverse events
Time frame: From Cycle 1 Day 1 (C1D1) until 28 days after the final dose. A cycle is 28 days.
[Stage 1 and Stage 2] PK parameters: the maximum concentration (Cmax) of HS-10352
Time frame: Cycle 1 Day 1 (C1D1)，at the first day of Cycle 1 (each cycle is 28 days)
[Stage 1] PK parameters: the maximum concentration (Cmax) of fulvestrant
Time frame: Cycle 1 (28 days)
[Stage 1 and Stage 2] PK parameters: time of the maximum concentration (Tmax) of HS-10352
Time frame: Cycle 1 Day 1 (C1D1)，at the first day of Cycle 1 (each cycle is 28 days)
[Stage 1] PK parameters: time of the maximum concentration (Tmax) of fulvestrant
Time frame: Cycle 1 (28 days)
[Stage 1 and Stage 2] PK parameters: elimination half life (t1/2) of HS-10352
Time frame: Cycle 1 Day 1 (C1D1)，at the first day of Cycle 1 (each cycle is 28 days)
[Stage 1 and Stage 2] PK parameters: area under the concentration-time curve over 24 hours (AUC0-24) of HS-10352
Time frame: Cycle 1 Day 1 (C1D1)，at the first day of Cycle 1 (each cycle is 28 days)
[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
Time frame: Cycle 1 Day 1 (C1D1)，at the first day of Cycle 1 (each cycle is 28 days)
[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
Time frame: From Cycle 1 to Cycle 2， each cycle is 28 days
[Stage 1 and Stage 2] PK parameters: the maximum concentration at steady-state (Css,max) of HS-10352
Time frame: Cycle 2 Day 1 (C2D1)，at the first day of Cycle 2 (each cycle is 28 days) each cycle is 28 days
[Stage 1] PK parameters: the maximum concentration at steady-state (Css,max) of fulvestrant
Time frame: Cycle 2 (28 days)
[Stage 1 and Stage 2] PK parameters: time of the maximum concentration at steady state (Tss,max) of HS-10352
Time frame: Cycle 2 Day 1 (C2D1)，at the first day of Cycle 1 (each cycle is 28 days)
[Stage 1] PK parameters: time of the maximum concentration at steady state (Tss,max) of fulvestrant
Time frame: Cycle 2 (28 days)
[Stage 1 and Stage 2] PK parameters: the minimum concentration at steady-state (Css,min) of HS-10352
Time frame: Cycle 2 Day 1 (C2D1)，at the first day of Cycle 1 (each cycle is 28 days)
[Stage 1 and Stage 2] PK parameters: the minimum concentration at steady-state (Css,min) of fulvestrant
Time frame: Cycle 2 (28 days)
[Stage 1] Efficacy of HS-10352 in combination with fulvestrant: ORR
Time frame: From the date of first dose until the date of disease progression or withdrawal from study, approximately 3 years
[Stage 1 and Stage 2] Efficacy of HS-10352 in combination with fulvestrant: disease control rate (DCR)
Time frame: From the date of first dose until the date of disease progression or withdrawal from study, approximately 3 years
[Stage 1 and Stage 2] Efficacy of HS-10352 in combination with fulvestrant: duration of response (DoR)
Time frame: From the date of CR, PR until the date of disease progression or withdrawal from study, approximately 3 years
[Stage 1 and Stage 2] Efficacy of HS-10352 in combination with fulvestrant: progression free survival (PFS)
Time frame: 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
[Stage 2] Efficacy of HS-10352 in combination with fulvestrant: overall survival (OS)
Time frame: From the date of randomization or first dose (if randomization is not needed) until the documentation of death from any cause, approximately 6 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2022.
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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.
Xichun Hu, PhD principal investigator
Fudan University
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 HS-10352 combined with fulvestrant (Stage 1) and HS-10352 combined with fulvestrant (Stage 2) in people with Breast Cancer, run by Jiangsu Hansoh 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 12 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: status not confirmed, as of the sponsor's last update on 17 Aug 2022. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xichun Hu, PhD (021-64175590, xchu2009@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
[Stage 1] Maximum tolerated dose (MTD) of HS-10352 in combination with fulvestrant (time frame: Cycle 1 (28 days)). The study lists 3 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 17 Aug 2022.