Actively Recruiting

Phase 1
Age: 18Years - 75Years
All Genders
NCT07189949

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

Led by Jiangsu HengRui Medicine Co., Ltd. · Updated on 2026-03-06

120

Participants Needed

1

Research Sites

163 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Understand and agree to participate in the study with good compliance
  • Aged between 18 and 75 years old
  • Have advanced solid tumors confirmed to have RAS mutations or amplifications and have failed standard treatment
  • ECOG performance status score of 0 or 1
  • Life expectancy greater than 3 months
  • At least one measurable tumor lesion according to RECIST v1.1
  • Adequate organ function
Not Eligible

You will not qualify if you...

  • Unrecovered toxicity from prior anti-tumor treatments worse than Grade 1 or as specified
  • Presence of central nervous system metastases
  • Gastrointestinal diseases affecting drug administration or absorption
  • Major surgery within 28 days before first dose or expected during the study
  • Serious pulmonary diseases
  • Active or recent (within 48 weeks) active tuberculosis infection
  • Active or persistent gastrointestinal bleeding within 6 months
  • History of allogeneic bone marrow or solid organ transplantation
  • History of deep vein thrombosis or pulmonary embolism within 6 months
  • Uncontrolled pleural effusion, pericardial effusion, or ascites requiring intervention
  • Positive HIV test or active chronic hepatitis B or C infection
  • Known allergy to any component of the study drug

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Tianjin Medical University Cancer Institute and Hospital

Tianjin, Tianjin Municipality, China, 300181

Actively Recruiting

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Research Team

R

Rongfu Mao

CONTACT

J

Jizhao Li

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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