Solid TumorsPhase 2NCT07417501
Lenvatinib Plus PD-1 Inhibitor for Advanced Solid Tumors With 11q13 Amplification
A Phase 2 study testing Lenvatinib plus PD-1 Inhibitor in people with Solid Tumors, run by Tongji Hospital at 2 sites in China.
Trial summary
The goal of this clinical trial is to learn if the combination of lenvatinib and a PD-1 inhibitor (a type of immunotherapy) works to treat advanced solid tumors that have a specific genetic change called "11q13 amplification". It will also learn about the safety of this combination. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Tumors
- What is being tested?
- Lenvatinib plus PD-1 Inhibitor
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 2 sitesChina
- Study dates
- 7 May 2026to 1 Mar 2029
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China2 sites, 2 recruiting
- Not yet recruiting
Tongji Hospital
Wuhan, Hubei
Yang WU, M.D., 13636076910, 255001907@qq.com
Wanguang Zhang, M.D.
- Recruiting
Tongji Hospital
Wuhan, Hubei
Yang WU, M.D., 13636076910, 255001907@qq.com
About this study
Official title: A Single-Arm, Multicenter, Exploratory Study of Lenvatinib Combined With PD-1 Inhibitor in Advanced Solid Tumors With Chromosome 11q13 Amplification
The goal of this clinical trial is to learn if the combination of lenvatinib and a PD-1 inhibitor (a type of immunotherapy) works to treat advanced solid tumors that have a specific genetic change called "11q13 amplification". It will also learn about the safety of this combination. The main questions it aims to answer are:
How many participants' tumors shrink or stop growing after receiving the combination therapy? What side effects do participants have when taking this combination therapy? All participants in this study will receive the same drug combination. Researchers will look at the results to see how well the treatment works.
Read more
Participants will:
Take lenvatinib orally once daily and receive PD-1 inhibitor by intravenous infusion every 3 weeks.
Visit the clinic regularly for checkups, blood tests, and CT or MRI scans to see how the tumor is responding.
Be followed for side effects and survival over time.
- Conditions
- Solid Tumors
- Being tested
- Lenvatinib plus PD-1 Inhibitor
- Keywords
- 11q13 Amplification, Lenvatinib, PD-1 Inhibitor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lenvatinib plus PD-1 InhibitorDrug
This is a combination therapy. Lenvatinib is administered orally once daily at a weight-based dose (12 mg for patients ≥60 kg; 8 mg for patients <60 kg). The PD-1 inhibitor component is not fixed; specific agents (such as pembrolizumab, sintilimab, etc.) may be used according to institutional standards and drug availability. The PD-1 inhibitor is administered intravenously at a dose of 200 mg every 3 weeks. Treatment continues until disease progression, unacceptable toxicity, or other protocol-specified criteria for discontinuation are met.
| Study group | Role | What they receive |
|---|---|---|
| Lenvatinib + PD-1 Inhibitor Combination Therapy | Experimental | This is a basket trial arm. All enrolled participants, regardless of their specific solid tumor type (e.g., esophageal carcinoma, head and neck squamous cell carcinoma, etc.), receive the same intervention: the combination of lenvatinib and a PD-1 inhibitor. Patients are eligible if they have advanced solid tumors with chromosome 11q13 amplification. Receives: Drug: Lenvatinib plus PD-1 Inhibitor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Response Rate (ORR)
Proportion of participants achieving a best overall response of Complete Response (CR) or Partial Response (PR) according to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1). Tumor response will be assessed by investigators via contrast-enhanced CT or MRI scans.
Measured: From first dose of study treatment until the first documented disease progression or start of new anticancer therapy, whichever occurs first, assessed up to approximately 24 months.
Secondary outcomes (4)
Disease Control Rate (DCR)
Measured: From first dose until disease progression or start of new therapy, assessed up to 24 months.
Progression-Free Survival (PFS)
Measured: From first dose until progression or death, assessed up to 24 months.
Overall Survival (OS)
Measured: From first dose until death from any cause, assessed up to approximately 36 months.
Incidence of Treatment-Related Adverse Events (TRAEs)
Measured: From first dose until 30 days after the last dose.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2026
- Study start7 May 2026
- Primary completion1 Mar 2028 (estimated)
- Study completion1 Mar 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid TumorsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tongji Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wan-Guang Zhang, Tongji Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07417501
- Sponsor's protocol ID
- LEN-PD1-11q13-001
- Status last verified
- Feb 2026
- First submitted
- 10 Feb 2026
- Last updated
- 14 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-Arm, Multicenter, Exploratory Study of Lenvatinib Combined With PD-1 Inhibitor in Advanced Solid Tumors With Chromosome 11q13 Amplification
- ClinicalTrials.gov ID
- NCT07417501
- Acronym / sponsor ID
- LEN-PD1-11q13-001
- Conditions
- Solid Tumors
- Keywords
- 11q13 Amplification, Lenvatinib, PD-1 Inhibitor
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Tongji HospitalUniversity, hospital or other
- Study start
- 7 May 2026 (actual)
- Primary completion
- 1 Mar 2028 (estimated)
- Study completion
- 1 Mar 2029 (estimated)
- First posted
- 18 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical trial is to learn if the combination of lenvatinib and a PD-1 inhibitor (a type of immunotherapy) works to treat advanced solid tumors that have a specific genetic change called "11q13 amplification". It will also learn about the safety of this combination. The main questions it aims to answer are:
How many participants' tumors shrink or stop growing after receiving the combination therapy? What side effects do participants have when taking this combination therapy? All participants in this study will receive the same drug combination. Researchers will look at the results to see how well the treatment works.
Participants will:
Take lenvatinib orally once daily and receive PD-1 inhibitor by intravenous infusion every 3 weeks.
Visit the clinic regularly for checkups, blood tests, and CT or MRI scans to see how the tumor is responding.
Be followed for side effects and survival over time.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Lenvatinib + PD-1 Inhibitor Combination Therapy | Experimental | Drug: Lenvatinib plus PD-1 InhibitorThis is a basket trial arm. All enrolled participants, regardless of their specific solid tumor type (e.g., esophageal carcinoma, head and neck squamous cell carcinoma, etc.), receive the same intervention: the combination of lenvatinib and a PD-1 inhibitor. Patients are eligible if they have advanced solid tumors with chromosome 11q13 amplification. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lenvatinib plus PD-1 InhibitorThis is a combination therapy. Lenvatinib is administered orally once daily at a weight-based dose (12 mg for patients ≥60 kg; 8 mg for patients <60 kg). The PD-1 inhibitor component is not fixed; specific agents (such as pembrolizumab, sintilimab, etc.) may be used according to institutional standards and drug availability. The PD-1 inhibitor is administered intravenously at a dose of 200 mg every 3 weeks. Treatment continues until disease progression, unacceptable toxicity, or other protocol-specified criteria for discontinuation are met. | Drug | Lenvatinib + PD-1 Inhibitor Combination Therapy |
Primary outcome
Objective Response Rate (ORR)
Time frame: From first dose of study treatment until the first documented disease progression or start of new anticancer therapy, whichever occurs first, assessed up to approximately 24 months.
Proportion of participants achieving a best overall response of Complete Response (CR) or Partial Response (PR) according to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1). Tumor response will be assessed by investigators via contrast-enhanced CT or MRI scans.
4 secondary outcomes
Disease Control Rate (DCR)
Time frame: From first dose until disease progression or start of new therapy, assessed up to 24 months.
Progression-Free Survival (PFS)
Time frame: From first dose until progression or death, assessed up to 24 months.
Overall Survival (OS)
Time frame: From first dose until death from any cause, assessed up to approximately 36 months.
Incidence of Treatment-Related Adverse Events (TRAEs)
Time frame: From first dose until 30 days after the last dose.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Lenvatinib plus PD-1 Inhibitor in people with Solid Tumors, run by Tongji Hospital at 2 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 14 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yang WU, M.D. (13636076910, 255001907@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective Response Rate (ORR) (time frame: From first dose of study treatment until the first documented disease progression or start of new anticancer therapy, whichever occurs first, assessed up to approximately 24 months.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Oct 2026.