New pill targets Hard-to-Treat cancers with KRAS mutation
NCT ID NCT07718165
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
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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 247 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Aug 2026
- Expected to finish
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Jun 2030
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. 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.
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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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Fudan University Shanghai Cancer Center
RECRUITINGShanghai, Shanghai Municipality, 201321, China
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