A Study of SHR-A1921 for Injection in Subjects With Advanced Solid Tumours
NCT ID: NCT05154604
Last Updated: 2021-12-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE1
156 participants
INTERVENTIONAL
2021-12-31
2024-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Treatment group: SHR-A1921
SHR-A1921
Treatment group: Subjects will receive an intravenous infusion of SHR-A1921 in a dose escalation until confirmed progression, unaccepted toxicity, or any criterion for withdrawal from the study.
Interventions
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SHR-A1921
Treatment group: Subjects will receive an intravenous infusion of SHR-A1921 in a dose escalation until confirmed progression, unaccepted toxicity, or any criterion for withdrawal from the study.
Eligibility Criteria
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Inclusion Criteria
2. Aged 18-75 years (inclusive), males and females;
3. Consents to provide tumor tissue samples;
4. Subjects must have histologically or clinically confirmed advanced and/or metastatic malignancies for which failure of standard treatment or lack of effective standard treatment;
5. At least one measurable lesion according to RECIST v1.1;
6. ECOG score of 0-1;
7. Expected survival ≥ 12 weeks;
8. Adequate bone marrow reserve and organ function ；
9. 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
2. Macrovascular invasion based on imaging;
3. Cancerous ascites, pleural effusion or pericardial effusion with clinical symptoms;
4. Has a history of a second malignancy;
5. History of immunodeficiency disease or organ transplant;
6. Uncontrolled cardiac diseases or symptoms;
7. Has a history of non-infectious ILD/pneumonitis that required steroids, or has current ILD/pneumonitis;
8. Has a history of active chronic enteritis 6 weeks prior to the initiation of the study treatment or intestinal obstruction, gastrointestinal perforation 3 months prior to the initiation of the study treatment;
9. Has a history of Grade≥2 bleeding 4 weeks prior to the initiation of the study treatment or is current receiving anticoagulation therapy;
10. Subjects with active hepatitis B or active hepatitis C;
11. Subjects who have received systemic anti-tumor treatments 4 weeks prior to the initiation of the study treatment.
12. Has unresolved toxicities from previous anticancer therapy.
13. Has a history of severe hypersensitivity reactions to either the drug substances or inactive ingredients of SHR-A1921;
14. Subjects 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.
18 Years
ALL
No
Sponsors
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Suzhou Suncadia Biopharmaceuticals Co., Ltd.
INDUSTRY
Responsible Party
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Central Contacts
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Other Identifiers
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SHR-A1921-I-101
Identifier Type: -
Identifier Source: org_study_id