A Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of HS-10502 Combination Treatment in Subjects With Advanced Solid Tumors

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

HS-10502 is a PARP1-specific selective inhibitor. The purpose if this study is to assess the safety, tolerability, pharmacokinetics (PK), and efficacy of HS-10502 Combination Treatment in subjects with advanced solid tumors.

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

• Males or females aged 18 years or older (≥18 years).

• Patients diagnosed with pathologically confirmed advanced solid tumors.

• Subjects have at least one target lesion as assessed per the RECIST 1.1.

• Eastern Cooperative Oncology Group Performance Status (ECOG PS) score of 0 to 1 and no deterioration within 2 weeks before the first dose.

• Have a life expectancy of at least 12 weeks.

• Female subjects of childbearing potential are willing to take appropriate contraceptive measures and should not breastfeed from signing the informed consent until 6 months after the last dose; male subjects must agree to use barrier contraception (i.e. condoms) from signing the informed consent to 6 months after the last dose.

• Female subjects must have a negative pregnancy test within 7 days prior to the first dose (for subjects with tumor related abnormal elevation of human chorionic gonadotropin \[HCG\], an ultrasound of uterus and appendages should be performed within 7 days prior to the first dose to rule out pregnancy), or demonstrate no risk for pregnancy.

• Subject must be voluntarily enrolled in this clinical trial, be able to understand the study procedures and to sign written informed consent.

Locations
Other Locations
China
Fudan University Shanghai Cancer Center
RECRUITING
Shanghai
Contact Information
Primary
Xi Yan
yanx1@hspharm.com
18721195312
Time Frame
Start Date: 2025-05-07
Estimated Completion Date: 2026-08-31
Participants
Target number of participants: 157
Treatments
Experimental: Cohort 1
Advanced prostate cancer
Experimental: Cohort 2
Advanced prostate cancer or solid tumor
Experimental: Cohort 3
Advanced HER2-negative breast cancer or recurrent ovarian cancer
Experimental: Cohort 4
Recurrent ovarian cancer
Experimental: Cohort 5
Platinum-sensitive recurrent ovarian cancer
Experimental: Cohort 6
Advanced gastric cancer or solid tumor
Experimental: Cohort 7
HRD positive advanced ovarian cancer, fallopian tube cancer or primary peritoneal cancer
Sponsors
Leads: Jiangsu Hansoh Pharmaceutical Co., Ltd.

This content was sourced from clinicaltrials.gov

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