drugset / Trial / NCT06936748
SFRT+Sequential Hypofractionated/Conventional Fractionated RT+Iparomlimab and Tuvonralimab for Relapsed/Refractory Solid Tumors
Phase 2
Recruiting
30 enrolled
Second Affiliated Hospital of Nanchang University
Qilu Pharmaceutical Co., Ltd. · collab
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Iparomlimab | Monoclonal antibody | 5 mg/kg | Intravenous |
| Subject | Tuvonralimab | Monoclonal antibody | 5 mg/kg | Intravenous |