Lenvatinib Plus PD-1 Inhibitor for Advanced Solid Tumors With 11q13 Amplification

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.

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 Overview

• Status: Not yet recruiting
• Conditions: Solid Tumors
• Intervention / Treatment: Drug: Lenvatinib plus PD-1 Inhibitor

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Yang WU, M.D.; Phone Number: 13636076910; Email: 255001907@qq.com

Study Locations

• China
  • Hubei
    • Wuhan, Hubei, China
      • Tongji Hospital
      • Principal Investigator: Wanguang Zhang, M.D.
      • Contact: Yang WU, M.D.; Phone Number: 13636076910; Email: 255001907@qq.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Lenvatinib + PD-1 Inhibitor Combination Therapy; 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.

Drug: Lenvatinib plus PD-1 Inhibitor; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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 Outcome Measures

Outcome Measure	Time Frame
Disease Control Rate (DCR)	From first dose until disease progression or start of new therapy, assessed up to 24 months.
Progression-Free Survival (PFS)	From first dose until progression or death, assessed up to 24 months.
Overall Survival (OS)	From first dose until death from any cause, assessed up to approximately 36 months.
Incidence of Treatment-Related Adverse Events (TRAEs)	From first dose until 30 days after the last dose.

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of Hyperprogressive Disease (HPD)	HPD is defined as meeting all of the following three criteria based on RECIST 1.1: 1) Time-to-treatment failure (TTF) < 2 months; 2) Progressive disease (PD) as the best overall response with ≥50% increase in the sum of target lesion diameters from baseline; 3) Tumor growth kinetics ratio (TGKR) ≥ 2, comparing the tumor growth rate during treatment to the pre-treatment rate.	From first dose of study treatment until the first tumor assessment (approximately 8 weeks)

Collaborators and Investigators

• Sponsor: Tongji Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): March 1, 2026
• Primary Completion (Estimated): March 1, 2028
• Study Completion (Estimated): March 1, 2029

Study Registration Dates

• First Submitted: February 10, 2026
• First Submitted That Met QC Criteria: February 10, 2026
• First Posted (Actual): February 18, 2026

Study Record Updates

• Last Update Posted (Actual): February 18, 2026
• Last Update Submitted That Met QC Criteria: February 10, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: Lenvatinib; PD-1 Inhibitor; 11q13 Amplification
• Additional Relevant MeSH Terms: Antineoplastic Agents, Immunological; Antineoplastic Agents; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Therapeutic Uses; Immune Checkpoint Inhibitors; lenvatinib
• Other Study ID Numbers: LEN-PD1-11q13-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No