Breast CancerPhase 1NCT04631835
Phase I Study of the HS-10352 in Patients With Advanced Breast Cancer
A Phase 1 study testing HS-10352 in people with Breast Cancer, run by Jiangsu Hansoh Pharmaceutical Co., Ltd. at 3 sites in China.
Trial summary
HS-10352 is a highly potent and selective small molecule inhibitor of phosphoinositide 3-kinase (p110α). In preclinical studies, it demonstrated strong activity against PI3K p110α in vitro and in vivo, and inhibited tumor cell growth. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Breast Cancer
- What is being tested?
- HS-10352
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 3 sitesChina
- Study dates
- 8 Sep 2020to 31 Aug 2023
- 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 to 75 years
- 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, and less than (<) 75 years.
- HR+ HER2- locally advanced or metastatic breast cancer patients confirmed by histology or cytology for who that standard treatment is invalid, unavailable or intolerable.
- Patients have at least one target lesion according to RECEST 1.1. The requirements for target lesions are: measurable lesions without local treatment such as irradiation, or with definite progress after local treatment, with the longest diameter ≥ 10 mm in the baseline period (in case of lymph nodes, the shortest axis ≥ 15 mm is required)
- ECOG performance status was 0-1 and did not deteriorate in the previous 2 weeks.
- Estimated life expectancy greater than (>) three months.
- Females should be using adequate contraceptive measures throughout the study; should not be breastfeeding at the time of screening, during the study and until 3 months after completion of the study; and must have evidence of non-childbearing potential.
- Sign Informed Consent Form.
Who cannot join
- Treatment with any of the following:
- Previous or current treatment with PI3K, AKT or mTOR inhibitors.
- 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.
- Major surgery (including craniotomy, thoracotomy, or laparotomy, etc.) within 4 weeks of the first dose of study drug.
- Inadequate bone marrow reserve or organ function.
Show all 14Show fewer
- 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.
- History of hypersensitivity to any active or inactive ingredient of HS-10352 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
3 sites in 1 country.
China3 sites, 3 recruiting
- Recruiting
Hunan Cancer Hospital
Changsha, Hunan
- Recruiting
SUN YAT-SEN Memorial Hospital
Guanzhou, Guangdong
Herui Yao
Herui Yao
- Recruiting
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, 200000
Xichun Hu, 086-021-64175590, xchu2009@hotmail.com
Xichun Hu
About this study
Official title: A Phase 1, Open-label, Multicenter Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Efficacy of Single and Multiple Doses of Oral Administration of HS-10352 in Patients With Locally Advanced or Metastatic Breast Cancer Progressing After Standard Therapy
HS-10352 is a highly potent and selective small molecule inhibitor of phosphoinositide 3-kinase (p110α). In preclinical studies, it demonstrated strong activity against PI3K p110α in vitro and in vivo, and inhibited tumor cell growth. The first-in-human trial is conducted to assess the maximum tolerated dose (MTD) and dose limiting toxicity (DLT), to evaluate the pharmacokinetics, safety and preliminary anti-tumor activity of HS-10352 at single dose and multiple doses.
Read the detailed description
This is a phase I, open-label, multicenter study to evaluate safety, tolerability, pharmacokinetics, and efficacy of single and multiple doses of oral administration of HS-10352 in patients with locally advanced or metastatic breast cancer with hormone receptor (HR) positive and epidermal growth factor receptor 2 (HER2) negative who have progressed following prior therapy. There is a dose-escalation study, which is designed to evaluate the safety, tolerability, and pharmacokinetics of single dose and multiple doses of HS-10352 given once every day (QD). An alternative dosing schedule of twice every day (BID) may be investigated if the drug clearance of HS-10352 is faster than anticipated.
All patients will be carefully followed for adverse events during the study treatment and for 28 days after the last dose of study drug. Subjects of this study will be permitted to continue therapy with assessments for progression once every 8 weeks, if the product is well tolerated and the subject has stable disease or better. As the disease progresses, survival follow-up is recommended bimonthly.
- Conditions
- Breast Cancer
- Being tested
- HS-10352
- Keywords
- dose-escalation, advanced solid tumors, estrogen receptor positive breast cancer, 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-10352Drug
Participants will receive single dose of HS-10352 on Day 1 of Cycle 1 followed by once daily from Day 8 of Cycle 1. (Cycle length: 35 days for Cycle 1 and 28 days for all other cycles). Participants will continue treatment until the end of the study in the absence of unacceptable toxicities and unequivocal disease progression.
| Study group | Role | What they receive |
|---|---|---|
| HS-10352 | Experimental | There are five escalating dose cohorts Receives: Drug: HS-10352 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of subjects with any dose limiting toxicity (DLT)
DLT is defined as one of the following HS-10352 related adverse event (AE) that occurs during the DLT period, excluding AE assessed by investigator exclusively related to subject's underlying disease or medical condition (graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE), Version 5.0):
Measured: From the single dose to the last dose of the first cycle defined as 28 days of multiple dosing (35 days).
To determine the maximum tolerated dose (MTD)
MTD was defined as the previous dose level at which 2 of 2 subjects or 2 out of 6 subjects experienced a DLT.
Measured: From the single dose to the last dose of the first cycle defined as 28 days of multiple dosing (35 days).
Secondary outcomes (14)
Incidence and severity of treatment-emergent adverse events
Assessed by number and severity of adverse events as recorded on the case report form, vital signs, laboratory variables, physical examination, electrocardiogram, RECIST1.1, and NCI CTCAE v5.0.
Measured: From baseline until 28 days after the last dose
Observed maximum plasma concentration (Cmax) after single dose of HS-10352
In the study of single-dose, Cmax will be obtained following administration of a single oral dose of HS-10352 on Day 1 to Day 6.
Measured: From pre-dose to 120 hours after single dose on Day 1
Observed maximum plasma concentration (Cmax ss) after multiple dose of HS-10352
At multiple-dose, Cmax ss will be obtained on Day 1 of dosing in the second 28-Day cycle of therapy.
Measured: From pre-dose to 24 hours after the first dose of multiple dosing on Day 1 of the second 28-Day cycle of therapy
Time to reach maximum plasma concentration (Tmax) after single dose of HS-10352
In the study of single-dose, Tmax will be obtained following administration of a single oral dose of HS-10352 on Day 1 to Day 6.
Measured: From pre-dose to 120 hours after single dose on Day 1
Time to reach maximum plasma concentration (Tmax) after multiple dose of HS-10352
At multiple-dose, Tmax will be obtained on Day 1 of dosing in the second 28-Day cycle of therapy.
Measured: From pre-dose to 24 hours after the first dose of multiple dosing on Day 1 of the second 28-Day cycle of therapy
Apparent terminal half-life (t1/2) after single dose of HS-10352
Apparent terminal half-life is the time measured for the concentration to decrease by one half. Terminal half-life calculated by natural log 2 divided by λz.
Measured: From pre-dose to 120 hours after single dose on Day 1
Area under plasma concentration versus time curve from zero to the 24-hour sampling time (AUC0-24) after single dose of HS-10352
Area under the plasma concentration versus time curve from time zero to the 24-hour sampling time at which the concentration was at or above the lower limit of quantification (LLQ). AUC0-24 was to be calculated according to the mixed log-linear trapezoidal rule.
Measured: From pre-dose to 24 hours after single dose on Day 1
Area under plasma concentration versus time curve from zero to last sampling time (AUC0-t) after single dose of HS-10352
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 (LLQ). AUC0-t was to be calculated according to the mixed log-linear trapezoidal rule.
Measured: From pre-dose to 120 hours after single dose on Day 1
Area under the plasma concentration versus time curve from time zero to infinity (AUC0-∞) after single dose of HS-10352
AUC0-∞ was calculated by combining AUC0-t and AUCextra. AUCextra represents an extrapolated value obtained by Clast/ λz, where Clast is the calculated plasma concentration at the last sampling time point at which the measured plasma concentration is at or above the LLQ and λz is the apparent terminal rate constant determined by log-linear regression analysis of the measured plasma concentrations of the terminal log-linear phase.
Measured: From pre-dose to 120 hours after single dose on Day 1
To further evaluation of the anti-tumor activity of HS-10352 by assessment of objective response rate (ORR)
Anti-tumor efficacy will be assessed by best radiographic response based on Response Evaluation Criteria in Solid Tumors at baseline (Day -28 to -1). For patients that continue on repeating 28-Day cycles after the primary evaluation period, progression will be assessed after each 8 weeks of therapy. ORR is defined as the percentage of patients with a complete response (CR) or partial response (PR) that was confirmed at a subsequent scan at least 4 weeks later, as assessed according to RECIST version 1.1.
Measured: From the date of first occurrence of complete response (CR) or partial response (PR) on 2 consecutive occasions (≥4 weeks), until the date of disease progression or withdrawal from study, approximately 3 years
Disease control rate of HS-10352
Objective response was assessed by RECIST 1.1 thereby to evaluate disease control rate. 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 first occurrence of confirmed CR or PR or SD until the date of disease progression or withdrawal from study, approximately 3 years
Deepness of response of HS-10352
Objective response was assessed by RECIST 1.1 thereby to evaluate deepness of response. Depth of response was defined as the relative change in the sum of the longest diameters of RECIST target lesions at the nadir in the absence of new lesions, or progression of non-target lesions compared with baseline.
Measured: From the date of enrollment until the date of disease progression or death, approximately 3 years
Progression-free survival of HS-10352
Progression of tumor was assessed by RECIST 1.1 thereby to evaluate progression free survival. Progression-free survival was defined as the time from date of first dose until the documentation of objective disease progression (PD) or death from any cause in the absence of progression (whichever occurred first), regardless of whether they subsequently received non-study anti-cancer therapy.
Measured: From the date of enrollment until the date of disease progression or death from any cause, approximately 3 years
Overall survival of HS-10352
Overall survival was defined as the time from date of first dose until the documentation of death from any cause.
Measured: From the date of enrollment until the date of death from any cause, approximately 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2020
- Study start8 Sep 2020
- Primary completion30 Apr 2023 (estimated)
- Study completion31 Aug 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 54 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jiangsu Hansoh Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04631835
- Sponsor's protocol ID
- HS-10352-101
- Status last verified
- Jun 2022
- First submitted
- 9 Nov 2020
- Last updated
- 15 Jun 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Ouyang Q, Wang Y, Zhang J, Wu Q, Wei H, Li C, Qian X, Hu X. HS-10352 in hormone receptor-positive, HER2-negative advanced breast cancer: A phase 1 dose-escalation trial. Cancer Med. 2023 Dec;12(24):21849-21860. doi: 10.1002/cam4.6755. Epub 2023 Dec 1.
PubMed 38037839
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Open-label, Multicenter Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Efficacy of Single and Multiple Doses of Oral Administration of HS-10352 in Patients With Locally Advanced or Metastatic Breast Cancer Progressing After Standard Therapy
- ClinicalTrials.gov ID
- NCT04631835
- Acronym / sponsor ID
- HS-10352-101
- Conditions
- Breast Cancer
- Keywords
- dose-escalation, advanced solid tumors, estrogen receptor positive breast cancer, PIK3CA gene mutation
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 54 participants (estimated)
- Lead sponsor
- Jiangsu Hansoh Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 8 Sep 2020 (actual)
- Primary completion
- 30 Apr 2023 (estimated)
- Study completion
- 31 Aug 2023 (estimated)
- First posted
- 17 Nov 2020 (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). In preclinical studies, it demonstrated strong activity against PI3K p110α in vitro and in vivo, and inhibited tumor cell growth. The first-in-human trial is conducted to assess the maximum tolerated dose (MTD) and dose limiting toxicity (DLT), to evaluate the pharmacokinetics, safety and preliminary anti-tumor activity of HS-10352 at single dose and multiple doses.
Detailed description
This is a phase I, open-label, multicenter study to evaluate safety, tolerability, pharmacokinetics, and efficacy of single and multiple doses of oral administration of HS-10352 in patients with locally advanced or metastatic breast cancer with hormone receptor (HR) positive and epidermal growth factor receptor 2 (HER2) negative who have progressed following prior therapy. There is a dose-escalation study, which is designed to evaluate the safety, tolerability, and pharmacokinetics of single dose and multiple doses of HS-10352 given once every day (QD). An alternative dosing schedule of twice every day (BID) may be investigated if the drug clearance of HS-10352 is faster than anticipated.
All patients will be carefully followed for adverse events during the study treatment and for 28 days after the last dose of study drug. Subjects of this study will be permitted to continue therapy with assessments for progression once every 8 weeks, if the product is well tolerated and the subject has stable disease or better. As the disease progresses, survival follow-up is recommended bimonthly.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HS-10352 | Experimental | Drug: HS-10352There are five escalating dose cohorts |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Men or women aged more than or equal to (≥) 18 years, and less than (<) 75 years.
- HR+ HER2- locally advanced or metastatic breast cancer patients confirmed by histology or cytology for who that standard treatment is invalid, unavailable or intolerable.
- Patients have at least one target lesion according to RECEST 1.1. The requirements for target lesions are: measurable lesions without local treatment such as irradiation, or with definite progress after local treatment, with the longest diameter ≥ 10 mm in the baseline period (in case of lymph nodes, the shortest axis ≥ 15 mm is required)
- ECOG performance status was 0-1 and did not deteriorate in the previous 2 weeks.
- Estimated life expectancy greater than (>) three months.
Key exclusion criteria (14 listed)
- Treatment with any of the following:
- 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.
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-10352Participants will receive single dose of HS-10352 on Day 1 of Cycle 1 followed by once daily from Day 8 of Cycle 1. (Cycle length: 35 days for Cycle 1 and 28 days for all other cycles). Participants will continue treatment until the end of the study in the absence of unacceptable toxicities and unequivocal disease progression. | Drug | HS-10352 |
Primary outcome
Number of subjects with any dose limiting toxicity (DLT)
Time frame: From the single dose to the last dose of the first cycle defined as 28 days of multiple dosing (35 days).
DLT is defined as one of the following HS-10352 related adverse event (AE) that occurs during the DLT period, excluding AE assessed by investigator exclusively related to subject's underlying disease or medical condition (graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE), Version 5.0):
To determine the maximum tolerated dose (MTD)
Time frame: From the single dose to the last dose of the first cycle defined as 28 days of multiple dosing (35 days).
MTD was defined as the previous dose level at which 2 of 2 subjects or 2 out of 6 subjects experienced a DLT.
14 secondary outcomes
Incidence and severity of treatment-emergent adverse events
Time frame: From baseline until 28 days after the last dose
Observed maximum plasma concentration (Cmax) after single dose of HS-10352
Time frame: From pre-dose to 120 hours after single dose on Day 1
Observed maximum plasma concentration (Cmax ss) after multiple dose of HS-10352
Time frame: From pre-dose to 24 hours after the first dose of multiple dosing on Day 1 of the second 28-Day cycle of therapy
Time to reach maximum plasma concentration (Tmax) after single dose of HS-10352
Time frame: From pre-dose to 120 hours after single dose on Day 1
Time to reach maximum plasma concentration (Tmax) after multiple dose of HS-10352
Time frame: From pre-dose to 24 hours after the first dose of multiple dosing on Day 1 of the second 28-Day cycle of therapy
Apparent terminal half-life (t1/2) after single dose of HS-10352
Time frame: From pre-dose to 120 hours after single dose on Day 1
Area under plasma concentration versus time curve from zero to the 24-hour sampling time (AUC0-24) after single dose of HS-10352
Time frame: From pre-dose to 24 hours after single dose on Day 1
Area under plasma concentration versus time curve from zero to last sampling time (AUC0-t) after single dose of HS-10352
Time frame: From pre-dose to 120 hours after single dose on Day 1
Area under the plasma concentration versus time curve from time zero to infinity (AUC0-∞) after single dose of HS-10352
Time frame: From pre-dose to 120 hours after single dose on Day 1
To further evaluation of the anti-tumor activity of HS-10352 by assessment of objective response rate (ORR)
Time frame: From the date of first occurrence of complete response (CR) or partial response (PR) on 2 consecutive occasions (≥4 weeks), until the date of disease progression or withdrawal from study, approximately 3 years
Disease control rate of HS-10352
Time frame: From the first occurrence of confirmed CR or PR or SD until the date of disease progression or withdrawal from study, approximately 3 years
Deepness of response of HS-10352
Time frame: From the date of enrollment until the date of disease progression or death, approximately 3 years
Progression-free survival of HS-10352
Time frame: From the date of enrollment until the date of disease progression or death from any cause, approximately 3 years
Overall survival of HS-10352
Time frame: From the date of enrollment until the date of death from any cause, approximately 5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2022.
- Derived from this study: PubMed 38037839Ouyang Q, Wang Y, Zhang J, Wu Q, Wei H, Li C, Qian X, Hu X. HS-10352 in hormone receptor-positive, HER2-negative advanced breast cancer: A phase 1 dose-escalation trial. Cancer Med. 2023 Dec;12(24):21849-21860. doi: 10.1002/cam4.6755. Epub 2023 Dec 1.
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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.
3 sites 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 in people with Breast Cancer, run by Jiangsu Hansoh Pharmaceutical Co., Ltd. at 3 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 14 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 15 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this 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 (086-021-64175590, xchu2009@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of subjects with any dose limiting toxicity (DLT) (time frame: From the single dose to the last dose of the first cycle defined as 28 days of multiple dosing (35 days).). 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?
On the ClinicalTrials.gov record for NCT04631835, which also lists 1 linked publication.
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 15 Jun 2022.