Advanced Solid Tumors Harboring RAS Mutations or Amplifications
Investigational drug(s) / intervention(s)
HRS-7172 Tablets
HRS-7172 Tablets: HRS-7172 tablets.
Study 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
Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
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:
1. Toxicity from prior anti-tumor treatment has not recovered to Grade ≤ 1 or a level specified in the inclusion/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.
Primary outcome measure(s)
Incidence and severity of adverse events (AEs) — From screening period up to 30 days after the last dose.
Incidence and severity of serious adverse events (SAEs) — From screening period up to 30 days after the last dose.
Dose-limiting toxicity (DLT) — From day 1 to day 24.
Maximum tolerated dose (MTD) — From day 1 to day 24.
Recommended Phase II Dose (RP2D) — From day 1 to day 24.
Trial sites (1)
Facility
City
Region
Status
Fudan University Affiliated Cancer Hospital
Shanghai
Shanghai Municipality
Recruiting
More Jiangsu HengRui Medicine Co., Ltd. trials in China
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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