Clinical trial · Interventional
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
NCT07142980CI-TRIAL-00097263recruitingPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Advanced Solid Tumors Harboring RAS Mutations or Amplifications | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| HRS-7172 Tablets | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- HRS-7172 Group
- description
- Oral HRS-7172.
- interventionNames
- Drug: HRS-7172 Tablets
Primary outcomes (5)
- measure
- Incidence and severity of adverse events (AEs)
- timeFrame
- From screening period up to 30 days after the last dose.
- measure
- Incidence and severity of serious adverse events (SAEs)
- timeFrame
- From screening period up to 30 days after the last dose.
- measure
- Dose-limiting toxicity (DLT)
- timeFrame
- From day 1 to day 24.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.