Status:
RECRUITING
Phase I Study of HRS-6093 in Participants With Advanced Solid Tumors Harboring KRAS G12D Mutations
Lead Sponsor:
Jiangsu HengRui Medicine Co., Ltd.
Conditions:
Advanced KRAS G12D Mutant Solid Tumors
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
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...
Eligibility Criteria
Inclusion
- Have fully understood this study and are willing to sign the ICF, with good compliance and cooperation in follow-up;
- Aged between 18-75 years, with no gender requirement;
- 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.
- ECOG performance status (PS) score of 0 or 1;
- Life expectancy \> 3 months;
- At least one measurable lesion per RECIST v1.1; A tumor tissue sample must be provided.
- Adequate organ function
Exclusion
- Toxicity (e.g., gastrointestinal reaction and skin toxicity) from prior anti-tumor treatment has not recovered to Grade ≤ 1 or a level specified in the inclusion/exclusion criteria;
- Presence of central nervous system (CNS) metastases;
- Participants with gastrointestinal diseases that affect drug administration/absorption
- 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;
- Presence of serious pulmonary diseases
- Active tuberculosis or a history of active tuberculosis infection within 48 weeks prior to screening, regardless of whether they have been treated;
- Active or persistent gastrointestinal bleeding within 6 months prior to screening;
- History of allogeneic bone marrow or solid organ transplantation;
- History of deep vein thrombosis or pulmonary embolism within 6 months prior to screening;
- Uncontrolled pleural effusion, pericardial effusion, or ascites requiring clinical intervention;
- Positive human immunodeficiency virus (HIV) (HIV1/2 antibodies), active chronic hepatitis B, or active hepatitis C (positive HCV antibody and positive HCV RNA);
- Known history of hypersensitivity to any component of the drug product to be used in the study;
Key Trial Info
Start Date :
September 16 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2028
Estimated Enrollment :
153 Patients enrolled
Trial Details
Trial ID
NCT07134998
Start Date
September 16 2025
End Date
December 1 2028
Last Update
December 5 2025
Active Locations (2)
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1
Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, China, 200025
2
West China Hospital of Sichuan University
Chengdu, Sichuan, China, 610041