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Recruiting Phase 1

HS-10502 Combination Treatment in Patients With Advanced Solid Tumors

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About this study

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.

Condition
Recurrent Ovarian Cancer, HER2-negative, Advanced Breast Cancer, TNBC, Advanced Prostate Cancer, Advanced Gastric Cancer
Tested
HS-10502 + NHA, HS-10502 + HS-20093, HS-10502+ Apatinib, HS-10502 + HS-20089, HS-10502 + Platinum + Bevacizumab, HS-1050...
Sponsor
Jiangsu Hansoh Pharmaceutical Co., Ltd.

Who can join

Age
18 years and older
Sex
All sexes
Healthy volunteers
Not accepted

Inclusion 10

  • Minimum age: 18 years
  • Study condition: Recurrent Ovarian Cancer, HER2-negative, Advanced Breast Cancer, TNBC, Advanced Prostate Cancer, Advanced Gastric Cancer
  • 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 24

  • 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.
  • Presence of pleural/abdominal effusion requiring clinical intervention.
  • Known history of other primary malignancy.
  • Evidence of brain metastasis and/or cancerous meningitis
  • Inadequate bone marrow reserve or hepatic/renal functions.
  • Cardiological examination abnormality.
  • Severe, uncontrolled or active cardiovascular disorders.
  • Serious or poorly controlled diabetes.
  • Serious or poorly controlled hypertension.
  • 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.
  • 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.
  • Pregnant or breast-feeding women or women who intend to become pregnant during the study.
  • Attenuated live vaccination within 4 weeks prior to the first dose.
  • Subjects with autoimmune disease that is active or is likely to recur.
  • 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.
  • Subjects unlikely to comply with study procedures, restrictions and requirement as determined by the investigator.
  • Subjects with any condition that jeopardizes the safety of the patient or interferes with the assessment of the study, as judged by the investigator.

Where

1 site, 1 recruiting

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, China

Recruiting

Contact

Potential match only. Final eligibility is determined by the study team.