Status:
UNKNOWN
A Study of HRS7415 Tablets in Patients With Advanced Malignant Tumors
Lead Sponsor:
Jiangsu HengRui Medicine Co., Ltd.
Conditions:
Advanced Malignant Tumor
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
Brief Summary
This study is a multicenter, open phase I clinical study of dose escalation and dose extension of HRS7415 in subjects with advanced malignant tumors. To evaluate the safety, tolerability, pharmacokine...
Eligibility Criteria
Inclusion
- Subjects volunteered to participate in the clinical study, understood the study procedure and was able to sign informed consent in person.
- 18 to 75 years old, male or female.
- ECOG Performance Status of 0 or 1.
- The estimated survival time is ≥12 weeks.
- Subjects with advanced or metastatic malignancy confirmed by histopathology or cytology.
- Solid tumor subjects had measurable lesions that met RECIST 1.1 criteria.
- Adequate hematology and terminal organ function, with vital organ function meeting the upper and lower limits required by the protocol.
- Male subjects and fertile female subjects must agree to use medically approved contraception during the study period and for 6 months following the study; Fertile female subjects must have a negative serum human chorionic gonadotropin (HCG) test within 7 days prior to initial dosing and must be non-lactation blood pregnancy test must be negative and not lactation.
Exclusion
- Subjects plan to receive any other antitumor therapy during the study period.
- Subjects received chemotherapy, radiotherapy, biotherapy, targeted therapy, or immunotherapy within 4 weeks prior to initial dosing.
- Major surgery other than diagnosis or biopsy was performed within 4 weeks prior to initial dosing.
- Received any other investigational drug or treatment that is not on the market within 4 weeks prior to initial dosing.
- The damage caused by any previous antineoplastic therapy has not recovered to grade ≤1.
- Imaging diagnosis showed tumor lesion or meningeal metastasis in the brain.
- Active heart disease in the 6 months prior to initial dosing.
- Had other malignancies within 5 years prior to first dosing.
- Subjects with poorly controlled hypertension and a previous history of hypertensive crisis or hypertensive encephalopathy.
- Having one of several factors affecting oral medication or having active gastrointestinal disease or other medical conditions that may result in significant influence on drug absorption, distribution, metabolism or excretion;
- Active hepatitis B and C;
- Serious infections that require intravenous antibiotics, antivirals or antifungals to control;
- History of immune deficiency or organ transplantation;
- Comorbidities or any other conditions that, in the investigator's judgment, seriously endanger patient safety or prevent patients from completing the study.
Key Trial Info
Start Date :
April 15 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 30 2023
Estimated Enrollment :
67 Patients enrolled
Trial Details
Trial ID
NCT05318833
Start Date
April 15 2022
End Date
October 30 2023
Last Update
April 8 2022
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