drugset / Trial / NCT06936748

SFRT+Sequential Hypofractionated/Conventional Fractionated RT+Iparomlimab and Tuvonralimab for Relapsed/Refractory Solid Tumors

NCT06936748

NaSingle-groupOpen-labelTreatment

Summary

Study Objectives Primary Objective:To evaluate the safety of SFRT followed by hypofractionated/conventional fractionated radiotherapy combined with Iparomlimab and Tuvonralimab Injection in relapsed/refractory bulky solid tumors. Secondary Objectives:To assess efficacy (objective response rate, disease control rate, progression-free survival, etc.) and identify predictive biomarkers.To explore correlations between immunologic biomarkers (e.g., PD-L1 expression, plasma IL-2/IL-10) and treatment outcomes. Study Endpoints Primary: Safety (incidence/severity of treatment-related adverse events). Secondary: ORR, DCR, DoR, mPFS, mOS Exploratory: Biomarker analysis (PD-L1, IL-2, IL-10).

Timeline

Start
2025-06-20
Primary completion
2028-06-19
Completion
2029-06-19

Drugs

EvaluationDrugModalityDoseRoute
Subject Iparomlimab Monoclonal antibody 5 mg/kg Intravenous
Subject Tuvonralimab Monoclonal antibody 5 mg/kg Intravenous

Indications