NCT07417501

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

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Tongji Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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. 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.

Conditions

• Solid Tumors

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2026-03-01
• Primary completion: 2028-03-01
• Completion: 2029-03-01
• First posted: 2026-02-18
• Last updated: 2026-02-18

Locations

1 site across 1 country: China