A Phase Ib Study of HS-10352 Plus Fulvestrant in Patients With Advanced Breast Cancer (NCT05504213) | Clinical Trial Compass
UnknownPhase 1
A Phase Ib Study of HS-10352 Plus Fulvestrant in Patients With Advanced Breast Cancer
China224 participantsStarted 2022-01-12
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. 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.
✓. ECOG performance status was 0-1 and did not deteriorate in the previous 2 weeks.
✓. Estimated life expectancy for at least three months
Exclusion criteria
✕. 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
What they're measuring
1
[Stage 1] Maximum tolerated dose (MTD) of HS-10352 in combination with fulvestrant
Timeframe: Cycle 1 (28 days)
2
[Stage 1] Maximum applicable dose (MAD) of HS-10352 in combination with fulvestrant
Timeframe: Cycle 1 (28 days)
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
. 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.
✕. Major surgery (including craniotomy, thoracotomy, or laparotomy, etc.) within 4 weeks of the first dose of study drug.
✕. With inflammatory breast cancer at screening.