drugset / Trial / NCT04234113
Study of Nanrilkefusp Alfa Alone and With Pembrolizumab in Adult Patients With Advanced/Metastatic Solid Tumors
Non-randomizedSequentialOpen-labelTreatment
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
Timeline
- Start
- 2019-06-13
- Primary completion
- 2024-08-31
- Completion
- 2024-11-27
Outcome
Missed primary endpoint
Stopped: “Due to lack of efficacy shown at the time of the interim analysis.”
release “Interim data from SOTIO’s clinical trials of nanrilkefusp alfa have shown insufficient efficacy to warrant further development in larger randomized trials in these specific indications and combinations.” sotio.com ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Nanrilkefusp alfa | Protein / enzyme biologic | 0.25 ug/kg | — |
| Subject | Nanrilkefusp alfa | Protein / enzyme biologic | 0.75 ug/kg | — |
| Subject | Nanrilkefusp alfa | Protein / enzyme biologic | 1.5 ug/kg | — |
| Subject | Nanrilkefusp alfa | Protein / enzyme biologic | 3 ug/kg | — |
| Subject | Nanrilkefusp alfa | Protein / enzyme biologic | 6 ug/kg | — |
| Subject | Nanrilkefusp alfa | Protein / enzyme biologic | 9 ug/kg | — |
| Subject | Nanrilkefusp alfa | Protein / enzyme biologic | 12 ug/kg | — |
| Subject | Nanrilkefusp alfa | Protein / enzyme biologic | 15 ug/kg | — |
| Subject | Pembrolizumab | Monoclonal antibody | 200 mg | Intravenous |
Indications
anus cancer
biliary tract cancer
cervical cancer
cutaneous neuroendocrine carcinoma
gastric cancer
head and neck squamous cell carcinoma
hepatocellular carcinoma
melanoma
mesothelioma
non-small cell lung carcinoma
ovarian cancer
renal cell carcinoma
skin squamous cell carcinoma
small cell lung carcinoma
thymus cancer
thyroid cancer
triple-negative breast carcinoma
urinary bladder cancer