Phase I Study of HRS-7053 Injection in the Treatment of Patients With Advanced Malignancies

Launched by JIANGSU HENGRUI MEDICINE CO., LTD. · Aug 7, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called HRS-7053 for patients with advanced cancer that hasn't responded to standard therapies. The main goal is to find out how safe the treatment is and to determine the highest dose that can be given without causing serious side effects. The study is currently not recruiting participants.

To be eligible for this trial, participants need to be at least 18 years old and have a confirmed diagnosis of advanced cancer that can be measured with scans. They should also be in generally good health, with a life expectancy of at least three months. Women who can become pregnant must have a negative pregnancy test before starting the treatment. Participants will be monitored closely to see how well they tolerate the medication and to gather important information that may help in future studies. If you're considering joining, it's a chance to contribute to research that could benefit others with similar conditions.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Voluntary participation in this study, signed informed consent, compliance is good, can cooperate with follow-up
• • 2. Age ≥18 years, both male and female
• • 3. Histologically or cytologically confirmed patients with advanced hematologic malignancies that have not responded to standard antitumor therapy and currently indicate treatment
• • 4. Have measurable lesions
• • 5. ECOG PS score: 0-1
• • 6. Have a life expectancy of at least 3 months
• • 7. The functional level of the major organs must meet the requirements
• • 8. Fertile female patients must have a serum pregnancy test within 7 days before the first medication and the result is negative; And must be non-lactating
• Exclusion Criteria:
• • 1. The tumor infiltrates the central nervous system
• • 2. Received autologous stem cell transplantation within 12 weeks prior to administration of the first study; Patients who have previously received allogeneic bone marrow transplantation or solid organ transplantation; In the first study, Car T cell therapy was administered within 12 weeks prior to drug administration
• • 3. Had major surgery or severe trauma 4 weeks prior to the first study; Or plan to undergo major surgery during the study
• • 4. Received antitumor therapy within 2 weeks prior to administration of the first study drug; Received Chinese herbal therapy within 2 weeks before the first dose of study drug administration; Receiving steroid hormones for antitumor purposes within 7 days before the first dose of the investigational drug administration
• • 5. Use of live attenuated vaccine within 28 days prior to signing the informed consent, or expected to require live attenuated vaccine during the study period to 5 months after the final dose
• • 6. Use of any potent drug that inhibits the liver drug metabolizing enzyme CYP3A for 14 days prior to first administration; Any potent drug that induces the liver drug metabolizing enzyme CYP3A has been used for 28 days prior to first administration
• • 7. Previous treatment-induced adverse events did not recover to ≤CTCAE grade 1
• • 8. Participating in other clinical studies or signing informed consent less than 1 month after the last medication in the previous clinical study
• • 9. The active phase of HBV or HCV infection is known
• • 10. A history of immunodeficiency, including HIV seropositive, or other acquired, congenital immunodeficiency disorders
• • 11. Active infection or unexplained fever \> 38.5 ° c
• • 12. A history of clinically severe cardiovascular disease; A history of myocarditis within one year prior to drug administration was first studied
• • 13. The abnormality of electrocardiogram (ECG) was clinically significant
• • 14. In the first study, cerebrovascular accident, transient ischemic attack occurred within 6 months prior to drug administration
• • 15. History of other malignancies within 5 years prior to drug administration was first studied
• • 16. Known allergy to any component of the HRS-7053 product
• • 17. The presence of other serious physical or mental illnesses, abnormal laboratory tests, and other factors that may increase the risk of participating in the study or interfere with the study results; And any other conditions that the investigator deems inappropriate for participation in this study
• • 18. Female subjects are pregnant or breastfeeding