drugset / Trial / NCT07417501

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

NCT07417501 ↗

Phase 2 Not yet recruiting 60 enrolled Tongji Hospital
NaSingle-groupOpen-labelTreatment

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.

Timeline

Start
2026-03-01
Primary completion
2028-03-01
Completion
2029-03-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Lenvatinib Small molecule 8 mg Oral
Subject Lenvatinib Small molecule 12 mg Oral
Subject Pembrolizumab Monoclonal antibody 200 mg Intravenous
Subject Sintilimab Monoclonal antibody 200 mg Intravenous

Indications