RecruitingPhase 1NCT07134998
Phase I Study of HRS-6093 in Participants With Advanced Solid Tumors Harboring KRAS G12D Mutations
A Phase I Study of HRS-6093 Evaluating Safety, Tolerability, and Pharmacokinetics in Participants With Advanced Solid Tumors Harboring KRAS G12D Mutations
Sponsor
Jiangsu HengRui Medicine Co., Ltd.
Enrollment
153 participants
Start Date
Sep 16, 2025
Study Type
INTERVENTIONAL
Conditions
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.
Eligibility
Min Age: 18 YearsMax Age: 75 Years
Inclusion Criteria7
- 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 Criteria11
- 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;
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Interventions
DRUGHRS-6093
HRS-6093
Locations(2)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07134998