PraG With RANKL Inhibitor for the Treatment of Advanced Multiple Metastatic Solid Tumors — PRaG 2X  

Metastatic Solid Tumor Clinical Trial

Official title: PhaseⅠ-Ⅱ Clinical Study of Hypofractionated Radiotherapy Combined With PD-1 Inhibitor Sequential GM-CSF(PraG) With RANKL Inhibitor for the Treatment of Advanced Multiple Metastatic Solid Tumors

Status Not yet recruiting

Clinical Trial Summary

The PraG treatment model has synergistic effects with RANKL inhibitor therapy, and the combination of the two treatments provides a survival benefit for patients with multiple bone metastatic solid tumors who have failed first-line systemic therapy. Phase I clinical trial is planned to determine the safety of PraG treatment mode combined with RANKL inhibitor desomumab and the optimal treatment sequence and mode. Further phase II clinical trial was conducted to confirm the efficacy of PraG treatment combined with desomumab. The mechanism of combination therapy was analyzed and biomolecular markers for potential efficacy prediction were screened by detection of lymphocyte subsets, cytokines and metabolomics in peripheral blood.

Clinical Trial Description

Group A(6 patients):patients were subcutaneously injected with 120mg desomumab, and on the second day after injection, the metastatic lesions were treated with hypofractioniated radiotherapy (8Gy×3F or 5Gy×3F), and subcutaneously injected with GM-CSF(200 μg/d) for 7 days, followed by IL-2 (2 million IU/d) for 7 days,and a 200mg PD-1 inhibitor administered within one week after completion of radiotherapy. The course was repeated every 28 days for 2-4 cycles.After combination therapy, maintenance therapy with PD-1inhibitor and desomumab was administered until disease progression or unacceptable toxicity.

Group B(6 patients):patients were treated with hypofractioniated radiotherapy (8Gy×3F or 5Gy×3F), and subcutaneously injected with GM-CSF(200 μg/d) for 7 days, followed by IL-2 (2 million IU/d) for 7 days.On the second day after radiotherapy, 200mg pd-1 inhibitor was administered. After treatment, 120mg desomumab was subcutaneously injected. The course was repeated every 28 days for 2-4 cycles.After combination therapy, maintenance therapy with PD-1inhibitor and desomumab was administered until disease progression or unacceptable toxicity.

The phase II study followed the treatment modality of the cohort with higher safety and efficacy assessments in the Phase I study and additional 39 patients were added.The primary endpoint is disease control rate. Secondary endpoints were objective response rate (ORR), median progression-free survival (PFS), overall survival (OS), and incidence of adverse events ;

Related Conditions & MeSH terms

• Metastatic Solid Tumor
• Neoplasms

• NCT number: NCT05435768
• Study type: Observational
• Source: Second Affiliated Hospital of Soochow University
• Contact: Yuehong Kong, Dr
• Phone: 13375183257
• Email: kkyuehong@163.com
• Status: Not yet recruiting
• Start date: August 16, 2022
• Completion date: August 15, 2025