New pill targets hard-to-treat cancers with KRAS mutation

NCT ID NCT07615413

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 636 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Jun 2026

An estimate. Start dates often move.

Expected to finish

Dec 2029

An estimate. End dates often move.

Lead sponsor

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

18 years and older

Sex

Anyone

Healthy volunteers

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

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

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How to take part

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  1. 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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