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

StatusRecruiting
PhasePhase 2
Started

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Record History

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  1. Recruitment opened
    • Study sites: 1 to 2
    • Start date changed from estimate of Mar 1, 2026 to May 7, 2026
    • Eligibility criteria expanded, about 14 words
  2. Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
Tongji Hospital
201 trials monitored
See 3 trials at risk
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.
Trial Details
NCT Number NCT07417501
Lead Sponsor Tongji Hospital
Conditions
(from sponsor)		 Solid Tumors
Enrollment 60 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov