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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05144061
Other study ID # HRS2398-I-101
Secondary ID
Status Recruiting
Phase Phase 1
First received
Last updated
Start date December 20, 2021
Est. completion date November 30, 2023

Study information

Verified date November 2022
Source Shanghai Hengrui Pharmaceutical Co., Ltd.
Contact Li Xiang
Phone 18661801805
Email li.xiang@hengrui.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The study is being conducted to determine the dose limited toxicity(DLT) and maximum tolerated dose(MTD) and recommended Phase 2 dose(RP2D) of HRS2398 in subjects with advanced malignant tumor ; The second objectives is to evaluate safety and preliminary efficacy and PK profile of HRS2398 in subjects with advanced malignant tumor ; Exploratory cohort is to explore the relationship between gene mutation and efficacy and resistance mechanisms.


Recruitment information / eligibility

Status Recruiting
Enrollment 122
Est. completion date November 30, 2023
Est. primary completion date May 31, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years to 70 Years
Eligibility Inclusion Criteria: 1. Subjects are able to give voluntary informed consent, understand the study and are willing to follow and complete all the test procedures. 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: 1. Untreated and/or uncontrolled brain metastases. 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.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
HRS2398 Tablets
Take 5mg to 320mg once or twice a day ; Oral administration , 21 days as a cycle.

Locations

Country Name City State
China Affiliated Cancer Hospital of Zhengzhou University/Henan Cancer Hospital Zhengzhou Henan

Sponsors (1)

Lead Sponsor Collaborator
Shanghai Hengrui Pharmaceutical Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Dose-limiting toxicity(DLT) up to 21 days
Primary Maximum tolerated dose(MTD) up to 6 months
Primary Recommended Phase II Dose (RP2D) up to 21 days
Secondary Number of subjects with adverse events and the severity of adverse events from the first drug administration to within 30 days for the last treatment dose
Secondary Cmax of HRS2398 of Single administration Single administration : 30min before administration of Day1, 5min, 0.25 hour, 0.5 hour, 0.75 hour, 1 hour , 2hours, 4hours, 6hours, 8hours, 10hours, 24hours, 48hours, 72hours after administration of Day1
Secondary Tmax of HRS2398 of Single administration Single administration : 30min before administration of Day1, 5min, 0.25 hour, 0.5 hour, 0.75 hour, 1 hour , 2hours, 4hours, 6hours, 8hours, 10hours, 24hours, 48hours, 72hours after administration of Day1
Secondary AUC0-t of HRS2398 of Single administration ingle administration : 30min before administration of Day1, 5min, 0.25 hour, 0.5 hour, 0.75 hour, 1 hour , 2hours, 4hours, 6hours, 8hours, 10hours, 24hours, 48hours, 72hours after administration of Day1
Secondary AUC0-12 of HRS2398 of Single administration Single administration : 30min before administration of Day1, 5min, 0.25 hour, 0.5 hour, 0.75 hour, 1 hour , 2hours, 4hours, 6hours, 8hours, 10hours after administration of Day1
Secondary T1/2 of HRS2398 of Single administration Single administration : 30min before administration of Day1, 5min, 0.25 hour, 0.5 hour, 0.75 hour, 1 hour , 2hours, 4hours, 6hours, 8hours, 10hours, 24hours, 48hours, 72hours after administration of Day1
Secondary Cmax of HRS2398 of Multiple doses Multiple administration: Day8, Day15, Day17 of Cycle1, Day1 of Cycle2-4 (each cycle is 21 days)
Secondary Tmax of HRS2398 of Multiple administration Multiple administration: Day8, Day15, Day17 of Cycle1, Day1 of Cycle2-4 (each cycle is 21 days)
Secondary AUC0-t of HRS2398 of Multiple administration Multiple administration: Day8, Day15, Day17 of Cycle1, Day1 of Cycle2-4 (each cycle is 21 days)
Secondary AUC0-12 of HRS2398 of Multiple administration Multiple administration: Day8, Day15, Day17 of Cycle1, Day1 of Cycle2-4 (each cycle is 21 days)
Secondary T1/2 of HRS2398 of Multiple administration Multiple administration: Day8, Day15, Day17 of Cycle1, Day1 of Cycle2-4 (each cycle is 21 days)
Secondary Bioavailability of fasting state PK blood samples from subjects were collected for bioavailability ,Postprandial AUC divided by fasting AUC up to 4 months
Secondary Objective Response Rate(ORR) Radiological scans performed at baseline then every 6 weeks until objective radiological disease progression up to 4 months
Secondary Disease Control Rate(DCR) Complete response + Partial response + Stable disease (CR+PR+SD) based on RECIST 1.1 up to 4 months
Secondary Duration of response (DoR) Time from documentation of tumor response to disease progression assessed among patients who had an objective response up to 4 months
Secondary Progression free survival(PFS) Defined as Progression free survival per RECIST 1.1 criteria according to Investigator's assessment up to 4 months
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