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Recruiting Phase 1

A Study of HRS-2329 in Participants With Advanced Solid Tumors Harboring RAS Mutations or Amplifications

NCT07189949 · tracked via the Priya Life Science China tracker
Phase
Phase 1
Started
2025-10-16
Last updated
2026-03-06

Condition(s) studied

Advanced Solid Tumors Harboring RAS Mutations or Amplifications

Investigational drug(s) / intervention(s)

HRS-2329 Tablet →

HRS-2329 Tablet: Oral HRS-2329 tablet.

Study summary

This is an open-label, multi-center phase I clinical study to evaluate the safety, tolerability, and pharmacokinetics of HRS-2329 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. Participants with histologically/cytologically confirmed advanced solid tumors who have been previously tested or are confirmed by the central laboratory to harbor RAS mutations or amplifications and have failed standard treatment; 4. ECOG performance status (PS) score of 0 or 1; 5. Life expectancy \> 3 months; 6. At least one measurable lesion per RECIST v1.1; 7. Adequate organ function. Exclusion Criteria: 1. Toxicity (e.g., gastrointestinal reaction and skin 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 the screening period to 30 days after the last dose.
    Graded as per CTCAE v5.0.
  • Incidence and severity of serious adverse events (SAEs). — From the screening period to 30 days after the last dose.
    Graded as per CTCAE v5.0.
  • Dose-limiting toxicity (DLT). — From Day 1 to Day 21.
  • Maximum tolerated dose (MTD). — From Day 1 to Day 21.
  • Recommended Phase II Dose (RP2D). — 24 months.

Trial sites (1)

FacilityCityRegionStatus
Tianjin Medical University Cancer Institute and Hospital Tianjin Tianjin Municipality Recruiting
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 NCT07189949 on ClinicalTrials.gov ↗ ← All trials in China