New combo targets genetic weakness in advanced cancers
NCT ID NCT07417501
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This phase 2 trial is testing whether a combination of lenvatinib (a targeted drug) and a PD-1 inhibitor (immunotherapy) can shrink or stop advanced solid tumors that have a specific genetic change called 11q13 amplification. About 60 adults with various cancers like esophageal, head and neck, breast, lung, or liver cancer will take lenvatinib daily and receive the immunotherapy every 3 weeks. Researchers will track tumor response, side effects, and survival to see if this approach is effective and safe.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- lenvatinib plus a PD-1 inhibitor (a type of immunotherapy)
- What this could lead to
- If it works, this could point toward a new treatment option for people with advanced cancers that have a specific genetic change (11q13 amplification).
- What could go wrong
- This is an early phase 2 trial with only 60 participants, so results may not apply to everyone. The combination may cause side effects or not work for many 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 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 60 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Mar 2026
An estimate. Start dates often move.
- Expected to finish
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Mar 2029
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
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: * Voluntary signing of the informed consent form, age ≥ 18 years at the time of signing, any gender. * Histologically or cytologically confirmed unresectable locally advanced or metastatic solid malignant tumor, including but not limited to: esophageal carcinoma, head and neck squamous cell carcinoma, breast cancer, lung cancer, hepatobiliary malignancies, and other solid tumors deemed eligible by the investigator. * Confirmed tumor presence of chromosome 11q13 amplification (amplification of at least one gene among CCND1, FGF3, FGF4, FGF19) via NGS testing. * No prior treatment with lenvatinib. * ECOG Performance Status of 0 or 1, with an estimated life expectancy ≥ 3 months. * At least one radiologically measurable lesion as defined by RECIST 1.1 criteria (tumor lesion with longest diameter ≥10 mm on CT scan, or lymph node with short axis ≥15 mm). * Adequate organ function. Exclusion Criteria: * Presence of active or previously documented autoimmune or inflammatory disorders. * Known hypersensitivity to any component of the study drugs (lenvatinib or PD-1 inhibitors). * Significant bleeding tendency or coagulation dysfunction, or occurrence of major bleeding within 4 weeks prior to enrollment. * Uncontrolled hypertension (systolic blood pressure ≥140 mmHg or diastolic blood pressure ≥90 mmHg) despite medication. * Received chemotherapy, radiotherapy, major surgery, or other anticancer therapy within 4 weeks prior to enrollment. * Pregnant or lactating women, or patients of childbearing potential unwilling to use effective contraception. * Inability to comply with the study protocol for treatment or scheduled follow-up assessments.
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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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Tongji Hospital
Wuhan, Hubei, China
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- Can a new drug shrink Hard-to-Treat head and neck tumors?
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