HRS-2329 for advanced solid tumors with RAS mutations or amplifications

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is an open-label, multicenter Phase 1 study testing oral HRS-2329 in adults with advanced solid tumors that harbor RAS mutations or amplifications. The study's primary focus is safety, tolerability, and characterization of pharmacokinetics, with participants enrolled who have measurable disease and adequate organ function. Eligible patients are adults (18–75) with ECOG 0–1 and prior standard therapies exhausted; key exclusions include active CNS metastases, gastrointestinal disorders affecting drug absorption, unresolved prior treatment toxicities, or recent major surgery. Dose escalation and pharmacokinetic sampling will guide early safety and dose selection decisions before any expansion cohorts.

Why it matters

Who can join: the full rules

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.

Where it's running

• Tianjin Medical University Cancer Institute and Hospital
  Tianjin, Tianjin Municipality, China Recruiting

Study contacts

• Study coordinator: Rongfu Mao
• Email: rongfu.mao@hengrui.com
• Phone: +86 021-61053363

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.