Trial results for a Phase 1 study (NCT04234113) investigating nanrilkefusp alfa alone and in combination with pembrolizumab for adult patients with advanced/metastatic solid tumors were posted on ClinicalTrials.gov on 2026-03-27. The study reported 2 dose-limiting toxicities (DLTs) at the highest monotherapy dose of nanrilkefusp alfa, while other tested doses showed 0 DLTs.
Background
The study, titled "Study of Nanrilkefusp Alfa Alone and With Pembrolizumab in Adult Patients With Advanced/Metastatic Solid Tumors," was designed as a multicenter, open-label Phase 1/1b study. Its primary objective was to evaluate the safety and preliminary efficacy of nanrilkefusp alfa as a monotherapy and in combination with pembrolizumab in patients with selected advanced/metastatic solid tumors, including Thyroid Cancer, Renal Cell Carcinoma, Non Small Cell Lung Cancer, Small-cell Lung Cancer, and Bladder Cancer.
Trial design
The study (NCT04234113) was a Phase 1, multicenter, open-label trial. It enrolled a total of 115 participants with advanced/metastatic solid tumors, specifically including Thyroid Cancer, Renal Cell Carcinoma, Non Small Cell Lung Cancer, Small-cell Lung Cancer, and Bladder Cancer. The trial investigated nanrilkefusp alfa as a monotherapy and in combination with pembrolizumab. The overall status of the trial is TERMINATED.
Key results
The primary safety outcome measured was the "Number of Participants With Dose-limiting Toxicities (DLTs)." The results for various dosing cohorts were as follows:
- In Part A (Nanrilkefusp Alfa Monotherapy):
- Nanrilkefusp Alfa 0.25 μg/kg: 0 DLTs
- Nanrilkefusp Alfa 0.75 μg/kg: 0 DLTs
- Nanrilkefusp Alfa 1.5 μg/kg: 0 DLTs
- Nanrilkefusp Alfa 3 μg/kg: 0 DLTs
- Nanrilkefusp Alfa 6 μg/kg: 0 DLTs
- Nanrilkefusp Alfa 9 μg/kg: 0 DLTs
- Nanrilkefusp Alfa 12 μg/kg: 0 DLTs
- Nanrilkefusp Alfa 15 μg/kg: 2 DLTs
- In Part A1 (Nanrilkefusp Alfa Divided Dosing, Monotherapy):
- Nanrilkefusp Alfa 9 μg/kg: 0 DLTs
- Nanrilkefusp Alfa 12 μg/kg: 0 DLTs
- In Part B (Nanrilkefusp Alfa Combined With Pembrolizumab):
- Nanrilkefusp Alfa 1.5 μg/kg: 0 DLTs
- Nanrilkefusp Alfa 3 μg/kg: 0 DLTs
What this means
The results from this Phase 1 study provide initial safety data for nanrilkefusp alfa as a monotherapy and in combination with pembrolizumab in patients with advanced/metastatic solid tumors. The observation of 0 dose-limiting toxicities across most tested doses, both for monotherapy and in combination with pembrolizumab, suggests a generally manageable safety profile at these dose levels. However, the occurrence of 2 DLTs at the highest monotherapy dose of nanrilkefusp alfa 15 μg/kg indicates a potential dose-dependent safety concern. The trial's overall status as TERMINATED suggests that development may not be proceeding as initially planned, potentially influenced by these safety findings or other factors not detailed in the available data.
Source
The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for study NCT04234113, titled "Study of Nanrilkefusp Alfa Alone and With Pembrolizumab in Adult Patients With Advanced/Metastatic Solid Tumors," were posted on 2026-03-27 on clinicaltrials.gov.