Phase
Condition
N/ATreatment
Test product: HYP-2090PTSA
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
A written informed consent should be signed by a subject or his/her legalrepresentative before any study-related procedures are performed;
18 Years and older;
Subjects with histologically or cytologically confirmed locally advanced ormetastatic advanced solid tumors;
Subjects must have at least one measurable lesion as defined by RECIST v1.1;
Eastern Cooperative Oncology Group(ECOG) performance status 0-1;
Expected survival ≥ 3 months;
Patients are willing to use a highly effective method of birth control during thestudy, and for at least 180 days after the last dose of study medication.
Exclusion
Exclusion Criteria:
Patients who have received major surgical or interventional treatment within 4 weeksprior to the first dose, with the exception of tumor biopsy, puncture, etc. Patientswho have received anti-tumor therapy (radiotherapy, immunologic therapy orbiological therapy) within 4 weeks, prior to the first dose, or received smallmolecular targeted therapy, chemotherapy within 2 weeks, or received palliativeradiotherapy for bone metastases within 2 weeks, or received nitrosoureas ormitomycin C within 6 weeks;
Patients who have received live vaccines within 4 weeks prior to the first dose;
Patients who have previously participated in clinical trials of other drugs within 4weeks before the first dose;
Patients with a history of central nervous system disease within 12 months prior toenrollment, such as seizures, cerebral vascular embolism/hemorrhage, paralysis,aphasia, severe brain injury, dementia, Parkinson's disease, cerebellar disease,organic brain syndrome, psychiatric disease, or any autoimmune disease withinvolvement of the central nervous system;
Presence of severe pulmonary diseases such as pulmonary embolism, interstitial lungdisease at screening;
Patients who have previously received allogeneic tissue/solid organ transplantation;
Patients with active infection;
Patients who are positive for human immunodeficiency virus (HIV) (HIV1/2 antibody),positive treponema pallidum antibody (positive treponema pallidum antibody isrequired to undergo a confirmatory test, and those with negative confirmatory testcan be enrolled), active chronic hepatitis B (HBsAg positive and HBV DNA > 500IU/mL) or active hepatitis C (HCV antibody positive and HCV-RNA > lower limit ofdetection by the research center);
Female subjects who are lactating or have a positive blood/urine pregnancy resultduring the screening period;
Any other condition of the subject (e.g., mental, geographical, or medicalcondition) that does not allow him or her to comply with the study and follow-upprocedures, or other conditions that, in the judgment of the investigator, thesubject is not suitable for inclusion in this study.
Study Design
Connect with a study center
Fujian Provincial Cancer Hospital
Fuzhou, Fujian 350000
ChinaActive - Recruiting
Hunan Provincial Cancer Hospital
Changsha, Hunan 410000
ChinaSite Not Available
The first Hospital of China Medical University
Shenyang, Liaoning 110000
ChinaSite Not Available
Shandong Provincial Cancer Hospital
Jinan, Shandong 250000
ChinaSite Not Available
Shanghai Pulmonary Hospital
Shanghai, Shanghai 200000
ChinaActive - Recruiting
West China Hospital of Sichuan University
Chengdu, Sichuan 610000
ChinaActive - Recruiting
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