A First-in-human Study of HRS2398 Tablets in Subjects With Advanced Malignant Tumors
NCT ID: NCT05144061
Last Updated: 2024-12-18
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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COMPLETED
PHASE1
28 participants
INTERVENTIONAL
2021-12-20
2024-02-21
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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Single Arm
HRS2398 Tablets
HRS2398 Tablets
Take 5mg to 320mg once or twice a day ; Oral administration , 21 days as a cycle.
Interventions
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HRS2398 Tablets
Take 5mg to 320mg once or twice a day ; Oral administration , 21 days as a cycle.
Eligibility Criteria
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Inclusion Criteria
2. subjects ≥18 years and ≤70 years.
3. Patients with Histologically or cytologically confirmed advanced Malignant tumors who had failed standard treatment or had not been treated with standard therapy.
4. ECOG ≤1.
5. Subjects with life expectancy of ≥ 3 months.
6. At least one measurable lesion ( RECIST version 1.1).
7. Subjects must have adequate organ function (whole blood or component transfusion or BFGF within 2 weeks before 1st dose of study drug is prohibited):
1. Absolute neutrophil count (ANC) ≥1.5 x10\^9/L;
2. Platelet count ≥ 100 x 10\^9/L;
3. Hemoglobin ≥ 90 g / L;
4. Total bilirubin (TBil) ≤1.5 x ULN;
5. Liver function tests alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤3 x ULN, for patients with known liver cancer or liver metastases, AST and ALT ≤ 5 x ULN;
6. Gr ≤ 1.5x ULN or an estimated glomerular filtration rate (eGFR) \> 50 mL/min;
7. INR ≤1.5 x ULN and APTT ≤ 1.5 x ULN;
8. LVEF≥50%，QTc Male: \<450ms; Female: \<470ms.
8. Subjects (males and females) of childbearing potential should be willing to use reliable contraception methods that are deemed effective by the investigator from visit 1 through 180 days following the last dose of study drug.
9. Archived wax lump tumor tissue samples or biopsy and blood sample collection during screening period.
10. As judged by the investigator, can follow protocol.
Exclusion Criteria
2. Patients with clinical symptoms of cancer ascites, pleural effusion, who need to drainage, or who have undergone ascites drainage within 2 weeks prior to the first administration.
3. Failure to recover from adverse events from the most recent anti-tumor treatment to CTCAE ≤ grade2.
4. Inability to swallow tablets or gastrointestinal disease, possible impairment of adequate absorption of study drugs.
5. Have severe cardiac disease:NYHA class ≥grade II heart failure; unstable angina pectoris；myocardial infarction within 12 months； clinically significant supraventricular or ventricular arrhythmias require treatment or intervention; Hypertension that cannot be well controlled by antihypertensive medication (systolic blood pressure ≥150 mmHg or diastolic blood pressure ≥100 mmHg).
6. Known active hepatitis C virus, or known active hepatitis B virus.
7. Allergic to the HRS2398 or the similar drug.
8. Concurrent anticancer treatment or use of other investigational product within 4 weeks before start of trial treatment; major surgery, radiotherapy, chemotherapy within 4 weeks before 1st dose of trial treatment.
9. The patient is currently using a drug known to be a strong inhibitor of CYP3A4 within 2 weeks before 1st dose of study drug ，or strong inducer of CYP3A4 within 4 weeks before 1st dose of study drug .
10. The investigator determined that the patient should not participate in the study.
18 Years
70 Years
ALL
No
Sponsors
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Shanghai Hengrui Pharmaceutical Co., Ltd.
INDUSTRY
Responsible Party
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Locations
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Affiliated Cancer Hospital of Zhengzhou University/Henan Cancer Hospital
Zhengzhou, Henan, China
Countries
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Other Identifiers
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HRS2398-I-101
Identifier Type: -
Identifier Source: org_study_id