RecruitingPhase 1NCT05740956

A Study of Hansoh (HS)-10502 in Patients With Advanced Solid Tumors

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


Sponsor

Jiangsu Hansoh Pharmaceutical Co., Ltd.

Enrollment

318 participants

Start Date

Jun 9, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

HS-10502 is a Poly(ADP-ribose) polymerase 1 (PARP1)-specific selective inhibitor. The purpose if this study is to assess the safety, tolerability, pharmacokinetics (PK), and efficacy of HS-10502 in subjects with homologous recombination repair (HRR) gene mutant or homologous recombination deficiency (HRD) positive advanced solid tumors.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new drug called HS-10502 (a PARP inhibitor) in patients with advanced solid tumors that have a specific type of DNA repair gene mutation called HRR (homologous recombination repair). Such mutations make cancer cells unable to fix their own DNA properly, which certain drugs can exploit. **You may be eligible if...** - You are between 18 and 75 years old - You have an advanced solid tumor with an HRR gene mutation (or HRD-positive) that has not responded to, or is not eligible for, standard treatments - Eligible cancer types include ovarian cancer (HRD positive), HER2-negative breast cancer, pancreatic cancer, prostate cancer, colorectal cancer, and others with HRR mutations - Your general health is good (ECOG 0–1) - Your expected survival is more than 12 weeks **You may NOT be eligible if...** - You have previously been treated with a PARP inhibitor - You have serious heart, liver, kidney, or blood count problems - You are pregnant or breastfeeding - You have had recent major surgery or radiation Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGHS-10502

HS-10502 will be administered once per day on a continuous dosing schedule starting on Cycle 1 Day 1 (C1D1) in a 28-day treatment cycle.


Locations(1)

Cancer Hospital Chinese Acedemy of Medical Sciences

Beijing, Beijing Municipality, China

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NCT05740956


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