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New pill targets Hard-to-Treat cancers with RAS mutations
NCT ID NCT07189949
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This early-stage study tests an experimental drug called HRS-2329 in people with advanced solid tumors that have RAS mutations or amplifications. The main goals are to check the drug's safety, find the best dose, and see how the body processes it. About 120 participants will take the drug by mouth, and researchers will monitor side effects and early signs of tumor control.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- HRS-2329 tablet
- What this could lead to
- If successful, this could lead to a new targeted therapy option for people with advanced solid tumors that have specific RAS mutations or amplifications.
- What could go wrong
- This is an early Phase 1 trial focused on safety and dosing, not yet on effectiveness. The drug may not shrink tumors or could cause side effects. Results may not apply to all RAS-mutant cancers.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 120 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Oct 2025
- Expected to finish
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Dec 2028
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 75 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Tianjin Medical University Cancer Institute and Hospital
RECRUITINGTianjin, Tianjin Municipality, 300181, China
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- New injectable drug tested for safety in Hard-to-Treat solid tumors
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