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Clinical trial · no report yet · Phase 1
AURELIO-03
Study of Nanrilkefusp Alfa Alone and With Pembrolizumab in Adult Patients With Advanced/Metastatic Solid Tumors
- NCT04234113 ↗
- Terminated
- SOTIO Biotech AG
- Focused
We haven't built an HCP commentary report on AURELIO-03 (nanrilkefusp alfa (SOT101); nanrilkefusp alfa (SOT101) plus pembrolizumab in advanced/metastatic solid tumors) yet. This page shows the registry record and the public commentary we found that names the trial. A report reads that commentary and sets out what clinicians said about the trial, each point linked to its source. How reports are made.
Indexed commentary on AURELIO-03 so far
Podcasts, YouTube videos and X posts we have indexed that name the trial. It is where a report starts, not where it ends: the build searches for more, so finished reports usually cover more than this.
| Channel | Indexed | |
|---|---|---|
| X threads | 3 |
The trial
ClinicalTrials.gov- Official title
- 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
- Phase
- Phase 1
- Status
- Terminated
- 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
- Nanrilkefusp alfa; Pembrolizumab
- Arms
- Part A (nanrilkefusp alfa monotherapy), nanrilkefusp alfa 0.25 μg/kg · Experimental
- Part A (nanrilkefusp alfa monotherapy), nanrilkefusp alfa 0.75 μg/kg · Experimental
- Part A (nanrilkefusp alfa monotherapy), nanrilkefusp alfa 1.5 μg/kg · Experimental
- Part A (nanrilkefusp alfa monotherapy), nanrilkefusp alfa 3 μg/kg · Experimental
- Part A (nanrilkefusp alfa monotherapy), nanrilkefusp alfa 6 μg/kg · Experimental
- Part A (nanrilkefusp alfa monotherapy), nanrilkefusp alfa 9 μg/kg · Experimental
- Part A (nanrilkefusp alfa monotherapy), nanrilkefusp alfa 12 μg/kg · Experimental
- Part A (nanrilkefusp alfa monotherapy), nanrilkefusp alfa 15 μg/kg · Experimental
- Part A1 (nanrilkefusp alfa divided dosing, monotherapy), nanrilkefusp alfa 9 μg/kg · Experimental
- Part A1 (nanrilkefusp alfa divided dosing, monotherapy), nanrilkefusp alfa 12 μg/kg · Experimental
- Part B (nanrilkefusp alfa combined with pembrolizumab), nanrilkefusp alfa 1.5 μg/kg · Experimental
- Part B (nanrilkefusp alfa combined with pembrolizumab), nanrilkefusp alfa 3 μg/kg · Experimental
- Part B (nanrilkefusp alfa combined with pembrolizumab), nanrilkefusp alfa 6 μg/kg · Experimental
- Part B (nanrilkefusp alfa combined with pembrolizumab), nanrilkefusp alfa 9 μg/kg · Experimental
- Part B (nanrilkefusp alfa combined with pembrolizumab), nanrilkefusp alfa 12 μg/kg · Experimental
- Part B1 (nanrilkefusp alfa divided dosing, combined with pembrolizumab), nanrilkefusp alfa 9 μg/kg · Experimental
- Part D (nanrilkefusp alfa monotherapy, expansion at the RP2D), nanrilkefusp alfa 12 μg/kg · Experimental
- Enrollment
- 115
- Primary outcomes
- Number of Participants With Dose-limiting Toxicities (DLTs)
- Number of Participants With Adverse Events (AEs)
- Number of Participants With Serious AEs (SAEs)
- Number of Participants With AEs Leading to Premature Discontinuation of Nanrilkefusp Alfa
- Number of Participants Who Died
- Number of Participants With Nanrilkefusp Alfa-related Clinical Laboratory Test Abnormalities (Coagulation; Hematology; Clinical Chemistry; Urinalysis; Thyroid and Cardiac Function)
- Sponsor
- SOTIO Biotech AG with SOTIO Biotech a.s.
- Start
- Jun 13, 2019
- Primary completion
- Aug 31, 2024
- Results posted
- Yes
- Registry record
- NCT04234113 · updated Mar 27, 2026