New pill targets Hard-to-Treat cancers with KRAS mutation

NCT ID NCT07718165

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 21, 2026 · Last updated Sep 04, 2026 · Updated 2 times

Summary

This phase I trial tests an experimental oral drug called ABSK211 in people with advanced solid tumors that have a KRAS gene alteration. The study aims to find a safe dose and see how well the drug works. Participants take ABSK211 by mouth once daily in 21-day cycles.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
an experimental oral drug called ABSK211
What this could lead to
If successful, this could lead to a new treatment option for people with advanced solid tumors that have a specific KRAS gene change.
What could go wrong
This is an early, first-in-human trial, so the drug may not be effective or could cause unexpected side effects. The results may not apply to all tumor types.

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 247 people

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

Started

Aug 2026

Expected to finish

Jun 2030

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. Participants should understand, sign, and date the written informed consent form prior to screening. 2. Male or female age 18 years or older 3. Participants with histologically confirmed locally-advanced or metastatic solid tumors harboring KRAS alteration 4. ECOG performance status 0 or 1 5. Life expectancy ≥ 3 months 6. Adequate organ function and bone marrow function 7. For participants participating exploration of food effect: 1)be able to eat a standardized high-fat, high caloric meal within 30 minutes. 2) be able to fast for 10 hours. Exclusion Criteria: 1. Known allergy or hypersensitivity to any component of the investigational product 2. Participants who were previously treated with any inhibitors targeting specific KRAS alleles, pan-KRAS inhibitors, pan- or multi-RAS inhibitors, or any other treatments directly targeting RAS. 3. Has a known additional malignancy that is progressing or has required active treatment 4. Has swallowing dysfunction or malabsorption syndrome 5. Previous anti-tumor therapy, including chemotherapy ,endocrine therapy, molecular targeted therapy or other investigational drugs received ≤2 weeks or ≤5-half life ,radiotherapy and antibody therapy received ≤4 weeks prior to initiation of study treatment. 6. Major surgery within 4 weeks of the first dose of investigational product or with any unhealed surgical wounds, infection or dehiscence. 7. Prior toxicities from chemotherapy, radiotherapy, and other anti-cancer therapies, including immunotherapy, that have not regressed to Grade ≤1 severity; 8. Participants use proton pump inhibitors for at least 7 days prior to the first dose of ABSK211 and during treatment with ABSK211. 9. P-gp inhibitor, moderate and strong CYP3A inhibitors to 7 days or 5 half-lives and for strong CYP3A inducers to 2 weeks or 5 half-lives ; 10. Active central nervous system (CNS) metastases; 11. History of interstitial lung disease (ILD) requiring systemic steroid treatment; 12. Heart disease or medical history ; 13. NSCLC cohorts: Participant previously identified as having a driver mutation and have not received any targeted therapy; 14. Known acquired immunodeficiency syndrome (AIDS)-related illness, or positive test for HIV 1/2 antibody; 15. Exclusion of hepatitis infection; 16. Participants with refractory/uncontrolled ascites or pleural effusion; 17. Pregnant or nursing (lactating) women; 18. Partners of non-surgically sterilized male participants or female participants of childbearing potential who refuse to use effective methods of birth control during the study and for up to 6 months after the last dose of investigational product; 19. Sexually active males who refuse to use a condom during medication period and until 3 months after stopping investigational product; 20. Vaccination with a live, attenuated vaccine within 4 weeks prior to the first dose of study treatment except for administration of inactivate vaccines ; 21. Any other clinically significant comorbidities, such as uncontrolled pulmonary disease, active infection, or any other condition; \-

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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.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

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Contacts and locations

Locations

  • Fudan University Shanghai Cancer Center

    RECRUITING

    Shanghai, Shanghai Municipality, 201321, China

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