NCT04234113

Study of Nanrilkefusp Alfa Alone and With Pembrolizumab in Adult Patients With Advanced/Metastatic Solid Tumors

A Multicenter Open-label Phase 1/1b Study to Evaluate the Safety and Preliminary Efficacy of SO-C101 as Monotherapy and in Combination With Pembrolizumab in Patients With Selected Advanced/Metastatic Solid Tumors

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 115 (actual)
• Sponsor: SOTIO Biotech AG · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

A multicenter open-label phase 1/1b study to evaluate the safety and preliminary efficacy of nanrilkefusp alfa as monotherapy and in combination with pembrolizumab in patients with selected advanced/metastatic solid tumors

Detailed description

This study will assess the safety and tolerability of nanrilkefusp alfa administered as monotherapy and in combination with an anti-PD-1 antibody (pembrolizumab) in patients with selected relapsed/refractory advanced/metastatic solid tumors (renal cell carcinoma, non-small cell lung cancer, small-cell lung cancer, bladder cancer, melanoma, Merkel-cell carcinoma, skin squamous-cell carcinoma, microsatellite instability high solid tumors, triple-negative breast cancer, mesothelioma, thyroid cancer, thymic cancer, cervical cancer, biliary tract cancer, hepatocellular carcinoma, ovarian cancer, gastric cancer, head and neck squamous-cell carcinoma, and anal cancer).

Conditions

• Thyroid Cancer
• Renal Cell Carcinoma
• Non Small Cell Lung Cancer
• Small-cell Lung Cancer
• Bladder Cancer
• Melanoma
• Merkel Cell Carcinoma
• Skin Squamous Cell Carcinoma
• Microsatellite Instability High
• Triple Negative Breast Cancer
• Mesothelioma
• Thymic Cancer
• Cervical Cancer
• Biliary Tract Cancer
• Hepatocellular Carcinoma
• Ovarian Cancer
• Gastric Cancer
• Head and Neck Squamous Cell Carcinoma
• Anal Cancer

Interventions

Type	Name	Description
DRUG	Nanrilkefusp alfa	A fusion protein which consists of the N-terminal sushi domain of human IL-15 receptor α covalently coupled via a linker of 20 amino acids to human IL-15
DRUG	Pembrolizumab	A humanized IgG4 monoclonal antibody with high specificity of binding to the PD-1 receptor

Timeline

• Start date: 2019-06-13
• Primary completion: 2024-08-31
• Completion: 2024-11-27
• First posted: 2020-01-21
• Last updated: 2026-03-27
• Results posted: 2026-03-27

Locations

12 sites across 4 countries: United States, Czechia, France, Spain

Regulatory

• FDA-regulated drug study