A Study of HRS7415 Tablets in Patients With Advanced Malignant Tumors

Advanced Malignant Tumor Clinical Trial

Official title:

A Phase I Clinical Study on the Safety, Tolerability, Pharmacokinetics and Efficacy of HRS7415 Tablets in Patients With Advanced Malignant Tumors

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05318833
• Other study ID #: HRS7415-I-101
• Status: Not yet recruiting
• Phase: Phase 1
• Start date: April 15, 2022
• Est. completion date: October 30, 2023

Study information

• Verified date: March 2022
• Source: Jiangsu HengRui Medicine Co., Ltd.
• Contact: Denghui Gao
• Phone: +0518-81220121
• Email: denghui.gao[@]hengrui.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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, pharmacokinetics and efficacy of HRS7415 tablets.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 67
• Est. completion date: October 30, 2023
• Est. primary completion date: February 28, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

1. Subjects volunteered to participate in the clinical study, understood the study procedure and was able to sign informed consent in person.

2. 18 to 75 years old, male or female.

3. ECOG Performance Status of 0 or 1.

4. The estimated survival time is =12 weeks.

5. Subjects with advanced or metastatic malignancy confirmed by histopathology or cytology.

6. Solid tumor subjects had measurable lesions that met RECIST 1.1 criteria.

7. Adequate hematology and terminal organ function, with vital organ function meeting the upper and lower limits required by the protocol.

8. 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 Criteria:

1. Subjects plan to receive any other antitumor therapy during the study period.

2. Subjects received chemotherapy, radiotherapy, biotherapy, targeted therapy, or immunotherapy within 4 weeks prior to initial dosing.

3. Major surgery other than diagnosis or biopsy was performed within 4 weeks prior to initial dosing.

4. Received any other investigational drug or treatment that is not on the market within 4 weeks prior to initial dosing.

5. The damage caused by any previous antineoplastic therapy has not recovered to grade =1.

6. Imaging diagnosis showed tumor lesion or meningeal metastasis in the brain.

7. Active heart disease in the 6 months prior to initial dosing.

8. Had other malignancies within 5 years prior to first dosing.

9. Subjects with poorly controlled hypertension and a previous history of hypertensive crisis or hypertensive encephalopathy.

10. 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;

11. Active hepatitis B and C;

12. Serious infections that require intravenous antibiotics, antivirals or antifungals to control;

13. History of immune deficiency or organ transplantation;

14. Comorbidities or any other conditions that, in the investigator's judgment, seriously endanger patient safety or prevent patients from completing the study.

Related Conditions & MeSH terms

• Advanced Malignant Tumor
• Neoplasms

Intervention

Drug:
• HRS7415
Drug: HRS7415

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Jiangsu HengRui Medicine Co., Ltd.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Dose-limiting toxicity (DLT)		From the beginning of first patient in (FPI) to the end of dose escalation phase up to approximately 10 months
Primary	maximum tolerated dose (MTD)		From the beginning of first patient in (FPI) to the end of dose escalation phase up to approximately 10 months
Primary	Phase II recommended dose (RP2D)		From the beginning of first patient in (FPI) to the end of dose escalation phase up to approximately 10 months
Secondary	Incidence, severity, duration, and association of adverse events (AE) and severe adverse events (SAE) with the study drug, in addition to abnormalities in vital signs, electrocardiogram, and laboratory tests		From the beginning of first patient in (FPI) to the end of study up to approximately 2 years
Secondary	Single dose parameters: Peak plasma concentration (Cmax) of HRS7415 and its main metabolite after single dosing		From the beginning of first patient in (FPI) to the end of study up to approximately 2 years
Secondary	Single dose parameters: Time to peak (Tmax) of HRS7415 and its main metabolite after single dosing		From the beginning of first patient in (FPI) to the end of study up to approximately 2 year
Secondary	Single dose parameters: Area under the curve from 0 to the last measurable concentration time point t (AUC0-t) of HRS7415 and its main metabolite after single dosing (if applicable)		From the beginning of first patient in (FPI) to the end of study up to approximately 2 years
Secondary	Single dose parameters: Area under the time curve from 0 to infinity (AUC0-inf) of HRS7415 and its main metabolite after single dosing (if applicable)		From the beginning of first patient in (FPI) to the end of study up to approximately 2 years
Secondary	Single dose parameters: Half-value period (t1/2) of HRS7415 and its main metabolite after single dosing (if applicable)		From the beginning of first patient in (FPI) to the end of study up to approximately 2 years
Secondary	Single dose parameters: Apparent volume of distribution (Vz/F) of HRS7415 and its main metabolite after single dosing (if applicable)		From the beginning of first patient in (FPI) to the end of study up to approximately 2 years
Secondary	Single dose parameters: Apparent clearance (CL/F) of HRS7415 and its main metabolite after single dosing (if applicable)		From the beginning of first patient in (FPI) to the end of study up to approximately 2 years
Secondary	Multiple dose parameters: Steady state peak concentration (Cmax,ss) of HRS7415 and its main metabolite after multiple dosing		From the beginning of first patient in (FPI) to the end of study up to approximately 2 years
Secondary	Multiple dose parameters: Time to peak (Tmax, ss) of HRS7415 and its main metabolite after multiple dosing		From the beginning of first patient in (FPI) to the end of study up to approximately 2 years
Secondary	Multiple dose parameters: Steady valley concentration (Cmin,ss) of HRS7415 and its main metabolite after multiple dosing		From the beginning of first patient in (FPI) to the end of study up to approximately 2 years
Secondary	Multiple dose parameters: Area under steady-state drug concentration-time curve (AUCss) of HRS7415 and its main metabolite after multiple dosing		From the beginning of first patient in (FPI) to the end of study up to approximately 2 years
Secondary	Multiple dose parameters: Drug storage ratio (Rac) of HRS7415 and its main metabolite after multiple dosing		From the beginning of first patient in (FPI) to the end of study up to approximately 2 years
Secondary	Efficacy endpoints: Objective response rate (ORR)		From the beginning of first patient in (FPI) to the end of study up to approximately 2 years
Secondary	Efficacy endpoints: Disease control rate (DCR)		From the beginning of first patient in (FPI) to the end of study up to approximately 2 years
Secondary	Efficacy endpoints: Duration of response (DoR)		From the beginning of first patient in (FPI) to the end of study up to approximately 2 years
Secondary	Efficacy endpoints: Progression-free survival (PFS)		From the beginning of first patient in (FPI) to the end of study up to approximately 2 years