Phase I Study of HRS-6093 in Participants With Advanced Solid Tumors Harboring KRAS G12D Mutations

NCT ID: NCT07134998

Last Updated: 2025-12-05

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE1
• Total Enrollment: 153 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-09-16
• Study Completion Date: 2028-12-31

Brief Summary

This is an open-label, multi-center phase I clinical study to evaluate HRS-6093 Safety, Tolerability, and Pharmacokinetics in Participants harboring KRAS G12D Mutations with advanced solid tumors. The study consists of dose escalation, dose expansion and efficacy expansion.

Conditions

Advanced KRAS G12D Mutant Solid Tumors

Study Design

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

Study Groups

HRS-6093

Group Type: EXPERIMENTAL

HRS-6093

Intervention Type: DRUG

HRS-6093

Interventions

HRS-6093

HRS-6093

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, with no gender requirement;

3. Participants with histologically/cytologically confirmed advanced solid tumors who have been previously tested or are confirmed by the central laboratory to harbor KRAS G12D mutations; Have failed standard treatment, are intolerant to standard treatment, or have not received standard treatment.

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

5. Life expectancy > 3 months;

6. At least one measurable lesion per RECIST v1.1; A tumor tissue sample must be provided.

7. 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

Shanghai Jiao Tong University School of Medicine

Shanghai, Shanghai Municipality, China

Site Status: RECRUITING

West China Hospital of Sichuan University

Chengdu, Sichuan, 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

Other Identifiers

HRS-6093-101

Identifier Type: -

Identifier Source: org_study_id