HRS-7172 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 phase I, open-label study gives HRS-7172 tablets to adults with advanced solid tumors harboring RAS mutations or amplifications to characterize safety, tolerability, and pharmacokinetics. Eligible participants are 18–75 years old with ECOG 0–1, measurable disease per RECIST v1.1, life expectancy >3 months, and adequate organ function. Key exclusions include untreated CNS metastases, significant pulmonary disease, gastrointestinal conditions that affect drug absorption, recent major surgery, unresolved toxicity from prior therapy, and recent active tuberculosis. The drug will be administered orally with dose escalation to identify a safe dose and collect safety and PK data at a single site in Shanghai.

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. ECOG performance status (PS) score of 0 or 1;
4. Life expectancy \> 3 months;
5. At least one measurable lesion per RECIST v1.1;
6. Adequate organ function.

Exclusion Criteria:

1. 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

• Fudan University Affiliated Cancer Hospital
  Shanghai, Shanghai 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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  This trial will test the oral drug HRS-2329 in adults with advanced solid tumors that have RAS mutations or amplifications who have not responded to standard treatments.

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• HRS-7172 with other cancer drugs in advanced pancreatic cancer

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• HRS-3005 in B-cell Malignancies

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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.