COMPANY

SOTIO Biotech

Profile checked Oct 10, 2026

Keywords: Hepatocellular Carcinoma Non Small Cell Lung Cancer Merkel Cell Carcinoma Ovarian Cancer Colorectal Cancer Thyroid Cancer Renal Cell Carcinoma Small-cell Lung Cancer Bladder Cancer Melanoma Skin Squamous Cell Carcinoma Microsatellite Instability High Triple Negative Breast Cancer Mesothelioma Thymic Cancer Cervical Cancer Biliary Tract Cancer Gastric Cancer Head and Neck Squamous Cell Carcinoma Anal Cancer Squamous Cell Carcinoma of the Lung Myxoid/Round Cell Liposarcoma Cutaneous Squamous Cell Carcinoma Castration-resistant Prostate Cancer CAR-GPC3 T Cells SOT201

5Trials (company is sponsor)

Timeline

May 1, 2024 Trial start Phase 1: A Study to Assess Safety and Efficacy of SOT201 in Patients With Advanced/Metastatic Cancer source ↗
Dec 22, 2022 Trial start Phase 2: A Study of Nanrilkefusp Alfa (SOT101) in Combination With Cetuximab to Evaluate the Efficacy and Safety in Patients With Colorectal Cancer source ↗
Oct 26, 2022 Trial start Phase 1/Phase 2: BOXR1030 T Cells in Subjects With Advanced GPC3-Positive Solid Tumors source ↗
Jun 21, 2022 Trial start Phase 2: A Study of SOT101 in Combination With Pembrolizumab to Evaluate the Efficacy and Safety in Patients With Selected Advanced Solid Tumors source ↗
Jun 13, 2019 Trial start Phase 1: Study of Nanrilkefusp Alfa Alone and With Pembrolizumab in Adult Patients With Advanced/Metastatic Solid Tumors source ↗

Upcoming milestones

2026-10 (ESTIMATED) · Phase 1 · A Study to Assess Safety and Efficacy of SOT201 in Patients With Advanced/Metastatic Cancer · NCT06163391

Estimated primary completion per ClinicalTrials.gov. Dates move.

Clinical trials (lead sponsor) 5

Record	Title	Phase	Status	Start	Primary completion
NCT04234113	Study of Nanrilkefusp Alfa Alone and With Pembrolizumab in Adult Patients With Advanced/Metastatic Solid Tumors	Phase 1	Terminated	Jun 13, 2019	Aug 31, 2024 (actual)
NCT05120271	BOXR1030 T Cells in Subjects With Advanced GPC3-Positive Solid Tumors	Phase 1/Phase 2	Active, not recruiting	Oct 26, 2022	Oct 24, 2025 (actual)
NCT05256381	A Study of SOT101 in Combination With Pembrolizumab to Evaluate the Efficacy and Safety in Patients With Selected Advanced Solid Tumors	Phase 2	Terminated	Jun 21, 2022	Aug 31, 2024 (actual)
NCT05619172	A Study of Nanrilkefusp Alfa (SOT101) in Combination With Cetuximab to Evaluate the Efficacy and Safety in Patients With Colorectal Cancer	Phase 2	Terminated	Dec 22, 2022	Mar 6, 2024 (actual)
NCT06163391	A Study to Assess Safety and Efficacy of SOT201 in Patients With Advanced/Metastatic Cancer	Phase 1	Recruiting	May 1, 2024	2026-10 (estimated)