A Phase I Study of HRS-7172 in Participants With Advanced Solid Tumors Harboring RAS Mutations or Amplifications

NCT ID: NCT07142980

Last Updated: 2025-11-17

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE1
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-09-12
• Study Completion Date: 2028-12-31

Brief Summary

This is a phase I study of HRS-7172 to evaluate safety, tolerability and pharmacokinetics in participants with advanced solid tumors harboring RAS mutations or amplifications.

Conditions

Advanced Solid Tumors Harboring RAS Mutations or Amplifications

Study Design

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

Study Groups

HRS-7172 Group

Oral HRS-7172.

Group Type: EXPERIMENTAL

HRS-7172 Tablets

Intervention Type: DRUG

HRS-7172 tablets.

Interventions

HRS-7172 Tablets

HRS-7172 tablets.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Have fully understood this study and are willing to sign the ICF, with good compliance and cooperation in follow-up;

2. Aged between 18-75 years old;

3. ECOG performance status (PS) score of 0 or 1;

4. Life expectancy > 3 months;

5. At least one measurable lesion per RECIST v1.1;

6. Adequate organ function.

Exclusion Criteria

2. Presence of central nervous system (CNS) metastases;

3. Participants with gastrointestinal diseases that affect drug administration/absorption;

4. Participants who have undergone major surgery other than diagnosis or biopsy within 28 days before the first dose, or are expected to undergo major surgery during the study period;

5. Presence of serious pulmonary diseases;

6. Active tuberculosis or a history of active tuberculosis infection within 48 weeks prior to screening, regardless of whether they have been treated;

7. Active or persistent gastrointestinal bleeding within 6 months prior to screening;

8. History of allogeneic bone marrow or solid organ transplantation;

9. History of deep vein thrombosis or pulmonary embolism within 6 months prior to screening;

10. Uncontrolled pleural effusion, pericardial effusion, or ascites requiring clinical intervention;

11. Positive human immunodeficiency virus (HIV) (HIV1/2 antibodies), active chronic hepatitis B, or active hepatitis C (positive HCV antibody and positive HCV RNA);

12. Known history of hypersensitivity to any component of the drug product to be used in 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

Locations

Fudan University Affiliated Cancer Hospital

Shanghai, Shanghai Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Rongfu Mao

Role: CONTACT

rongfu.mao@hengrui.com

+86-021-61053363

Jizhao Li

Role: CONTACT

jizhao.li.jl565@hengrui.com

+86-021-61053363

Facility Contacts

Xianjun Yu

Role: primary

yuxianjun@fudanpci.org

+86-021-64175590

Other Identifiers

HRS-7172-101

Identifier Type: -

Identifier Source: org_study_id