Clinical Trials Directory

Trials / Recruiting

RecruitingNCT06769425

HS-10502 Combination Treatment in Patients With Advanced Solid Tumors

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
Phase
Phase 1
Study type
Interventional
Enrollment
157 (estimated)
Sponsor
Jiangsu Hansoh Pharmaceutical Co., Ltd. · Industry
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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.

Detailed description

This is a phase I, multicenter, open-label clinical study to evaluate the safety, tolerability, PK, and efficacy of oral HS-10502 combination treatment in subjects with advanced solid tumors. The study will be divided into phase Ia (dose escalation) and phase Ib (dose expansion). The dose-escalation study will be conducted to evaluate the safety, tolerability, PK profile, and efficacy, as well as to determine the maximum tolerable dosage (MTD) or maximum applicable dose (MAD) of HS-10502 in combination with other antitumor agents (Enzalutamide, Rezvilutamide,Abiraterone,HS-20093,Apatinib,HS-20089,Platinum,Bevacizumab,nab-paclitaxel,Docetaxel, Irinotecan) The subsequent dose expansion study will select appropriate target populations (7 cohorts of recurrent ovarian cancer, HER2-negative advanced breast cancer, TNBC, advanced prostate cancer , advanced gastric cancer and HRD positive advanced ovarian cancer, fallopian tube cancer or primary peritoneal cancer) based on the data obtained in the phase Ia study, and determine the recommended phase II dose (RP2D) for each target population. Safety evaluation will be performed for all the subjects in each cycle of therapy (3 weeks or 2 weeks) until Cycle 16, and then once every 6 weeks, until 30 days or 90 days after the last dose. The PK characteristics of HS-10502 will be evaluated during screening period and study treatment. Efficacy evaluation will be performed once every 6 weeks after C1D1 until objective disease progression or withdrawal from the study. As the disease progresses, survival follow-up will be performed every 12 weeks from the last dose.

Conditions

Interventions

TypeNameDescription
DRUGHS-10502 + NHAHS-10502 + NHA
DRUGHS-10502 + HS-20093HS-10502 + HS-20093
DRUGHS-10502+ ApatinibHS-10502+ Apatinib
DRUGHS-10502 + HS-20089HS-10502 + HS-20089
DRUGHS-10502 + Platinum + BevacizumabHS-10502 + Platinum + Bevacizumab
DRUGHS-10502 + nab-paclitaxel or Docetaxel or IrinotecanHS-10502 + nab-paclitaxel or Docetaxel or Irinotecan
DRUGHS-10502 + BevacizumabHS-10502 + Bevacizumab

Timeline

Start date
2025-05-07
Primary completion
2026-05-07
Completion
2026-08-31
First posted
2025-01-10
Last updated
2025-06-24

Locations

1 site across 1 country: China

Source: ClinicalTrials.gov record NCT06769425. Inclusion in this directory is not an endorsement.