Clinical Trials in China / NCT07142980
Recruiting
Phase 1
A Phase I Study of HRS-7172 in Participants With Advanced Solid Tumors Harboring RAS Mutations or Amplifications
NCT07142980 · tracked via the Priya Life Science China tracker
Condition(s) studied
Advanced Solid Tumors Harboring RAS Mutations or Amplifications
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
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
Other trials for the same condition
Official registry record
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.
View NCT07142980 on ClinicalTrials.gov ↗ ← All trials in China