RecruitingPhase 1NCT07142980
A Phase I Study of HRS-7172 in Participants With Advanced Solid Tumors Harboring RAS Mutations or Amplifications
A Phase I Study of HRS-7172 Evaluating Safety, Tolerability and Pharmacokinetics in Participants With Advanced Solid Tumors Harboring RAS Mutations or Amplifications
Sponsor
Jiangsu HengRui Medicine Co., Ltd.
Enrollment
120 participants
Start Date
Sep 12, 2025
Study Type
INTERVENTIONAL
Conditions
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.
Eligibility
Min Age: 18 YearsMax Age: 75 Years
Inclusion Criteria6
- 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 old;
- ECOG performance status (PS) score of 0 or 1;
- Life expectancy \> 3 months;
- At least one measurable lesion per RECIST v1.1;
- 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-7172 Tablets
HRS-7172 tablets.
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07142980