HRS-7172 for advanced solid tumors with RAS mutations or amplifications

A Phase I Study of HRS-7172 Evaluating Safety, Tolerability and Pharmacokinetics in Participants With Advanced Solid Tumors Harboring RAS Mutations or Amplifications

This study will try an experimental oral drug called HRS-7172 in adults with advanced solid tumors that have RAS mutations or amplifications to see if it is safe and how the body handles it.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 120 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Jiangsu HengRui Medicine Co., Ltd. (Industry-sponsored)
• Locations: 1 site (Shanghai, Shanghai Municipality)
• Trial ID: NCT07142980 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Adults aged 18–75 with advanced solid tumors confirmed to have RAS mutations or amplifications, ECOG 0–1, measurable disease, and adequate organ function who can take oral medication are ideal candidates.

Not a fit: Patients with untreated CNS metastases, significant pulmonary disease, gastrointestinal conditions that affect absorption, recent major surgery, unresolved high-grade toxicities from prior therapy, or recent active tuberculosis are excluded and unlikely to benefit from participation.

Why it matters

Potential benefit: If successful, HRS-7172 could become a new oral treatment option targeting RAS-driven advanced solid tumors.

How similar studies have performed: Targeted drugs against specific RAS alterations (for example KRAS G12C inhibitors) have shown clinical activity, but broadly effective therapies for many RAS-driven tumors remain experimental, so this approach is early-stage and relatively novel.

Eligibility criteria

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 this trial is running

Shanghai, Shanghai Municipality

• Fudan University Affiliated Cancer Hospital — Shanghai, Shanghai Municipality, China (Recruiting)

Study contacts

• Study coordinator: Rongfu Mao

Conditions Advanced Solid Tumors Harboring RAS Mutations or Amplifications