Actively Recruiting

Phase 1
Age: 18Years +
All Genders
NCT06769425

HS-10502 Combination Treatment in Patients With Advanced Solid Tumors

Led by Jiangsu Hansoh Pharmaceutical Co., Ltd. · Updated on 2025-06-24

157

Participants Needed

1

Research Sites

68 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

HS-10502 Combination Treatment in Patients With Advanced Solid Tumors

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Male or female aged 18 years or older
  • Diagnosed with pathologically confirmed advanced solid tumors
  • Have at least one target lesion assessed by RECIST 1.1 criteria
  • Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 1 without deterioration within 2 weeks before first dose
  • Life expectancy of at least 12 weeks
  • Female subjects of childbearing potential willing to use contraception and not breastfeed from consent until 6 months after last dose
  • Male subjects willing to use barrier contraception from consent until 6 months after last dose
  • Female subjects must have a negative pregnancy test within 7 days before first dose or demonstrate no risk of pregnancy
  • Ability to understand study procedures and sign written informed consent
Not Eligible

You will not qualify if you...

  • Received or currently receiving PARP inhibitor, B7-H4, or B7-H3-targeted therapies
  • Received cytotoxic chemotherapy, investigational drugs, anti-tumor traditional Chinese medicines, or other anti-tumor drugs within 14 days before first dose or need to continue these during study
  • Presence of Grade 2 or higher toxicities from prior anti-tumor therapy
  • Presence of pleural or abdominal effusion requiring clinical intervention
  • History of other primary malignancies
  • Evidence of brain metastasis or cancerous meningitis
  • Inadequate bone marrow, liver, or kidney function
  • Abnormal cardiological examination
  • Severe, uncontrolled, or active cardiovascular disorders
  • Serious or poorly controlled diabetes or hypertension
  • Significant bleeding symptoms or tendency within 1 month before first dose
  • Serious infections within 4 weeks before first dose
  • Systemic glucocorticoid therapy for more than 7 days within 28 days before first dose, or need for chronic glucocorticoids during study
  • Acquired or congenital immunodeficiency, or history of organ transplantation
  • Active infectious diseases such as hepatitis B, hepatitis C, tuberculosis, syphilis, or HIV
  • Current hepatic encephalopathy, hepatorenal syndrome, or severe liver cirrhosis
  • Moderate or severe lung diseases affecting lung function or drug toxicity detection
  • History of severe neurological or psychiatric disorders
  • Pregnant or breastfeeding women or intending to become pregnant during study
  • Attenuated live vaccination within 4 weeks before first dose
  • Active autoimmune disease or likely recurrence
  • Gastrointestinal fistula, perforation, abscess, or intestinal obstruction symptoms within 6 months before first dose
  • Unlikely to comply with study procedures or requirements
  • Any condition that jeopardizes safety or interferes with study assessments as judged by investigator

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, China, 200032

Actively Recruiting

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Research Team

X

Xi Yan

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

7

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