A Study of HRS7415 Tablets in Patients With Advanced Malignant Tumors

NCT ID: NCT05318833

Last Updated: 2022-04-08

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1
• Total Enrollment: 67 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-04-15
• Study Completion Date: 2023-10-30

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, pharmacokinetics and efficacy of HRS7415 tablets.

Conditions

Advanced Malignant Tumor

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

HRS7415

Group Type: EXPERIMENTAL

HRS7415

Intervention Type: DRUG

Drug: HRS7415

Interventions

HRS7415

Drug: HRS7415

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Jiangsu HengRui Medicine Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Central Contacts

Denghui Gao

Role: CONTACT

denghui.gao@hengrui.com

+0518-81220121

Huan Li

Role: CONTACT

huan.li@hengrui.com

+0518-81220121

Other Identifiers

HRS7415-I-101

Identifier Type: -

Identifier Source: org_study_id