Tests HS-10502 combinations in people with advanced solid tumors

Trial details

Who runs it

Jiangsu Hansoh Pharmaceutical Co., Ltd.

Trial code

NCT06769425

Record updated

24 June 2025

Original description

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.Read full original descriptionShow less

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

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.

Inclusion: 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.

Exclusion: Have received or is currently receiving the following treatment: PARPi/B7-H4/B7-H3-targeted therapies; Have received or is currently receiving the following treatment: PARPi/B7-H4/B7-H3-targeted therapies; Have received any of cytotoxic chemotherapy drugs, investigational drugs, anti-tumor traditional Chinese medicines or other anti-tumor drugs within 14 days prior to the first dose of study drug; or need to continue these drugs during the study; Presence of Grade ≥ 2 toxicities as per Common Terminology Criteria for Adverse Events due to prior anti-tumor therapy; Clinically significant bleeding symptoms or significant bleeding tendency within 1 month prior to the first dose of study treatment; Serious infections within 4 weeks prior to the first dose; Have received systemic glucocorticoid therapy for more than 7 days within 28 days prior to the first dose study treatment, or require chronic (≥ 7 days) use of systemic glucocorticoids during the study, or have other acquired, congenital immunodeficiency disorders, or a history of organ transplantation; Attenuated live vaccination within 4 weeks prior to the first dose; Subjects with gastrointestinal fistula, visceral fistula, gastrointestinal perforation, or abdominal abscess, or with symptoms/signs of intestinal obstruction within 6 months prior to the first dose of study drug; Known history of other primary malignancy; Severe, uncontrolled or active cardiovascular disorders; Serious or poorly controlled diabetes; Serious or poorly controlled hypertension; Presence of active infectious diseases such as hepatitis B, hepatitis C, tuberculosis, syphilis, or human immunodeficiency virus infection, etc; Current hepatic encephalopathy, hepatorenal syndrome, or Child-Pugh Class B or more severe cirrhosis; Any moderate or severe lung diseases that may interfere with the detection and treatment of drug-related pulmonary toxicity or may seriously affect respiratory function; History of severe neurological or psychiatric disorder; Subjects with autoimmune disease that is active or is likely to recur; Subjects with any condition that jeopardizes the safety of the patient or interferes with the assessment of the study, as judged by the investigator; Presence of pleural/abdominal effusion requiring clinical intervention; Evidence of brain metastasis and/or cancerous meningitis; Inadequate bone marrow reserve or hepatic/renal functions; Cardiological examination abnormality; Pregnant or breast-feeding women or women who intend to become pregnant during the study; Subjects unlikely to comply with study procedures, restrictions and requirement as determined by the investigator.

ClinicalTrials.gov NCT06769425