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

Recruiting now · Phase 1

Conditions studied: Advanced Solid Tumors Harboring RAS Mutations or Amplifications

In brief

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.

Key facts

Study ID

NCT07189949

Run by

Jiangsu HengRui Medicine Co., Ltd.

People needed

120

Starts

2025-10-16

Expected to finish

2028-12-01

Last updated by the study team

2026-03-06

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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;
• Life expectancy > 3 months;
• At least one measurable lesion per RECIST v1.1;
• Adequate organ function.

You may not qualify if…

• 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;
• Presence of serious pulmonary diseases;
• Active tuberculosis or a history of active tuberculosis infection within 48 weeks prior to screening, regardless of whether they have been treated;
• Active or persistent gastrointestinal bleeding within 6 months prior to screening;
• History of allogeneic bone marrow or solid organ transplantation;
• History of deep vein thrombosis or pulmonary embolism within 6 months prior to screening;
• Uncontrolled pleural effusion, pericardial effusion, or ascites requiring clinical intervention;
• Positive human immunodeficiency virus (HIV) (HIV1/2 antibodies), active chronic hepatitis B, or active hepatitis C (positive HCV antibody and positive HCV RNA);
• Known history of hypersensitivity to any component of the drug product to be used in the study.

Where it is running

• Tianjin Medical University Cancer Institute and Hospital — Tianjin, Tianjin Municipality, China (enrolling)

Full record on ClinicalTrials.gov

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