New pill targets hard-to-treat cancers with KRAS mutation
NCT ID NCT07615413
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This early-stage study tests a new drug, HS-10541, in people with advanced solid tumors that have a specific genetic change called KRAS G12C. The drug is given alone or with other cancer treatments. The main goals are to check safety, find the right dose, and see if it shrinks tumors. About 636 adults with various advanced cancers will take part.
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 636 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Jun 2026
An estimate. Start dates often move.
- Expected to finish
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Dec 2029
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 years and older
- 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. Voluntary participation and written informed consent.. 2. Aged 18 years or older (≥18 years), of any gender. 3. Histologically or cytologically confirmed advanced solid tumor. 4. At least one measurable lesion according to RECIST v1.1. 5. ECOG PS of 0 to 1, with no deterioration within 2 weeks prior to the first dose. 6. With a life expectancy \> 12 weeks. 7. Adequate bone marrow reserve and organ function. 8. Female participants of childbearing potential and non-sterilized male participants must agree to use highly effective contraceptive measures from the time of signing the ICF until 6 months after the last dose. 9. Female participants of childbearing potential must be non-lactating; all female participants must have a negative pregnancy test prior to the first dose. Exclusion Criteria: 1. Uncontrolled pleural effusion, pericardial effusion, or abdominal effusion requiring clinical intervention. 2. Presence of symptomatic brain metastases, leptomeningeal/brainstem involvement, history of intracranial hemorrhage or intraspinal hemorrhage, or spinal cord compression. 3. Unresolved CTCAE ≥grade 2 toxicities from previous anticancer therapy. 4. History of a second primary malignancy 5. Severe, uncontrolled, or active cardiovascular or cerebrovascular diseases, or severe cardiac examination abnormalities. 6. Severe or poorly controlled diabetes mellitus or hypertension. 7. Known active infectious diseases. 8. Clinically significant gastrointestinal dysfunction. 9. Gastrointestinal obstruction or perforation occured. 10. Interstitial lung disease (ILD). 11. Participants with known hypersensitivity or contraindications to any active or inactive ingredients of the study drug, chemically similar drugs, or drugs of the same class. 12. Other inappropriate situation considered by the investigator.
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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 official record
The full official record for this study. This one lists no contact details, but it is the first place any would appear.
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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.