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

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

• 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

Locations
Other Locations
China
Fudan University Shanghai Cancer Center
RECRUITING
Shanghai
Contact Information
Primary
Xichun Hu, PhD
xchu2009@hotmail.com
021-64175590
Backup
Jian Zhang, PhD
syner2000@163.com
021-64175590
Time Frame
Start Date: 2022-01-12
Estimated Completion Date: 2025-12-31
Participants
Target number of participants: 224
Treatments
Experimental: Cohort 1: Endocrine therapy-resistant (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).
Experimental: Cohort 2: Endocrine therapy-resistant (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)
Experimental: Cohort 3: Endocrine therapy-sensitive or endocrine-naïve (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)
Related Therapeutic Areas
Sponsors
Leads: Jiangsu Hansoh Pharmaceutical Co., Ltd.

This content was sourced from clinicaltrials.gov