NCT06146985

Famitinib in Combination With Adebrelimab for the Treatment of Advanced Thyroid Cancer

A Multicohort, Single-Centre, Phase II Trial of the Efficacy and Safety of Famitinib in Combination With Adebrelimab for the Treatment of Advanced Thyroid Cancer

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 67 (estimated)
• Sponsor: Ruijin Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Accepted

Summary

This is a multi-cohort, open-label, single-centre, Phase 2 study aiming to investigate the efficacy and safety of a regimen using the multi-targeted kinase inhibitor Famitinib in combination with the PD-L1 antibody Adebrelimab for the patients with unresectable locally advanced or metastatic refractory to standard treatment differentiated thyroid cancer (DTC), medullary thyroid carcinoma (MTC) as well as Anaplastic thyroid carcinoma (ATC).

Detailed description

The participants who meet the inclusion criteria will be assigned to different cohorts to be treated. Participants will receive Adebrelimab 1200 mg intravenously once every three weeks (Q3W), together with Famitinib 20 mg orally daily before or after the diet. Participants will be given the regimen of Famitinib in combination with Adebrelimab during the Treatment phase until disease progression or undulated toxicity appears.

Conditions

• Thyroid Cancer

Interventions

Type	Name	Description
COMBINATION_PRODUCT	20 mg Famitinib & 1200 mg Adebrelimab	Famitinib is a novel multi-targeted tyrosine kinase inhibitor targeting VEGFR2, PDGFR, and c-kit. Adebrelizumab is a humanised immunoglobulin G4 (IgG4) monoclonal antibody that binds specifically to human PD-L1

Timeline

• Start date: 2023-12-01
• Primary completion: 2024-11-15
• Completion: 2025-05-01
• First posted: 2023-11-27
• Last updated: 2023-11-28