Can a pill block a key tumor driver? a new trial aims to find out
NCT ID NCT06800196
First seen Aug 05, 2026 · Last updated Aug 06, 2026 · Updated 1 time
Summary
This early-stage trial is testing an experimental oral drug called KNT-0916 in adults with advanced solid tumors that have specific changes in the FGFR2 gene. The study aims to see if the drug is safe, tolerable, and shows signs of shrinking or controlling tumors. Participants must have tumors that have not responded to standard treatments or for which no standard therapy exists.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- KNT-0916, an oral drug that blocks FGFR2, a protein that can help tumors grow
- What this could lead to
- If KNT-0916 proves safe and effective, it could offer a new treatment option for people with advanced solid tumors that have specific FGFR2 alterations and have not responded to standard therapies.
- What could go wrong
- This is an early-phase trial, so the drug may not work as hoped or may cause unexpected side effects. The results will need confirmation in larger studies before it could become a standard treatment.
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 151 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Apr 2025
- Expected to finish
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Dec 2027
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: * Histologically or cytologically confirmed unresectable or metastatic solid tumor * Documented FGFR2 gene fusion, mutation, or amplification per testing of blood and/or tumor * Patient must have measurable disease per RECIST v1.1 * Patient has ECOG performance status of 0-1 * Patient must have disease that is refractory to standard therapy, disease that has not adequately responded to standard therapy, disease for which standard or curative therapy does not exist, or the patient must be intolerant to or have declined standard therapy * An expected survival of ≥ 12 weeks. * Adequate organ function, as measured by laboratory values Exclusion Criteria: * Prior treatment with any FGFR2 target therapy. * Central nervous system metastasis with associated symptom and signs. * Clinically significant, uncontrolled cardiovascular disease. * History of interstitial lung disease, or infectious pneumonitis need heavy antibiotics therapy 5. As judged by the investigator, unsuitable for attending the study.
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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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Sun Yat-sen University Cancer Center
RECRUITINGGuangzhou, Guangdong, China
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