A Trial of SHR-1802 in Patients With Failure of Standard Treatment for Advanced Malignant Tumours

  • STATUS
    Recruiting
  • participants needed
    42
  • sponsor
    Jiangsu HengRui Medicine Co., Ltd.
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Updated on 19 February 2024
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cancer
measurable disease
bone marrow procedure

Summary

This is the first study to test SHR-1802 in humans. The primary purpose of this study is to see if SHR-1802 is safe and tolerable for patients with locally advanced/unresectable or metastatic malignancies that are refractory to available therapy or for which no standard therapy is available.

Details
Condition Cancer
Age 18-75 years
Treatment SHR-1802
Clinical Study IdentifierNCT04414150
SponsorJiangsu HengRui Medicine Co., Ltd.
Last Modified on19 February 2024

Eligibility

 Yes No Not Sure

Inclusion Criteria

Voluntary participation and written informed consent
Aged 18-75 years (inclusive), males and females
Patient must have histologically or clinically confirmed advanced and/or metastatic malignancies for which failure of standard treatment or lack of effective standard treatment
At least one measurable lesion according to RECIST v1.1
ECOG score of 0-1
Expected survival 12 weeks
Adequate bone marrow reserve and organ function were confirmed by baseline examination
For female patients of childbearing potential or male patients with partners of childbearing potential who are not sterilized by surgical operations, they are required to use a medically approved contraceptive measure during the study treatment period and within 3 months after the end of the study treatment; For female patients of childbearing potential who are not sterilized by surgical operations, they must have a negative serum HCG test result within 72 h prior to study enrollment; and they must not be in the lactation period

Exclusion Criteria

The presence of any active, known, or suspected autoimmune disease. Type 1 diabetes, which was admitted to receive stable dose of insulin, hypothyroidism, which required only hormone replacement therapy, skin disease with no need to systemic treatment and no acute exacerbation within 1 year before the screening period
Subjects who had received systemic treatment with corticosteroids or other immunosuppressive agents within 28 days prior to initial administration
Known and untreated central nervous system (CNS) or leptomeningeal metastases
Uncontrolled pleural effusion,or ascites requiring recurrent drainage procedures
Uncontrolled cardiac diseases or symptoms
Known hereditary or acquired bleeding and thrombotic tendencies
Patients who have previously received chemotherapy, radiotherapy or surgery which ended within 4 weeks prior to the start of this study; oral molecular targeted therapy with < 5 drug half-lives from the first study dose; or patients with AEs caused by previous treatment (except for alopecia) that have not returned to CTCAE Grade 1
Known active infection
Congenital and acquired immune deficiency
HBsAg-positive and HBV DNA > 2000 IU/mL(or 104 copies/mL); HCV RNA copies > ULN
Patients with other potential factors that may affect the study results or result in the premature discontinuation as determined by the investigator, such as alcoholism, drug abuse, other serious diseases (including mental illness) requiring concomitant treatment, serious laboratory abnormalities, or family or social factors that could affect the safety of the patients
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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