A Study of HRS-2329 in Participants With Advanced Solid Tumors Harboring RAS Mutations or Amplifications
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-75
SponsorJiangsu HengRui Medicine Co., Ltd.
About this trial
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 criteria
Qualifiers
Have fully understood this study and are willing to sign the ICF, with good compliance and cooperation in follow-up;
Aged between 18-75 years old;
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;
ECOG performance status (PS) score of 0 or 1;
Disqualifiers
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;
Presence of central nervous system (CNS) metastases;
Participants with gastrointestinal diseases that affect drug administration/absorption;
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;
Trial design
Treatments tested in this trial
- HRS-2329 Tablet
Treatment groups
120 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov