OncoMatch/Clinical Trials/NCT06163391
A Study to Assess Safety and Efficacy of SOT201 in Patients With Advanced/Metastatic Cancer
Is NCT06163391 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies SOT201 for advanced solid tumor.
Treatment: SOT201 — This is a Phase 1, open-label, dose escalation study to assess the safety, tolerability, and preliminary efficacy of SOT201 as monotherapy for participants aged 18 years or above with advanced unresectable or metastatic solid tumors During dose escalation, the recommended dose(s) of SOT201 given every 3 weeks (Q3W) will be determined
Check if I qualifyExtracted eligibility criteria
Cancer type
Tumor Agnostic
Disease stage
Metastatic disease required
advanced or metastatic solid tumors who have disease progression after treatment with available therapies for their disease that are known to confer clinical benefit
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: any therapy known to confer clinical benefit for their disease
disease progression after treatment with available therapies for their disease that are known to confer clinical benefit
Cannot have received: anti-PD-1 or anti-PD-L1 agent, pembrolizumab, or agent directed to another stimulatory or co-inhibitory T-cell receptor (e.g., CTLA-4, CD134 [OX40], CD137) with clinically relevant intolerability or severe hypersensitivity (pembrolizumab)
Known clinically relevant intolerability or severe hypersensitivity to prior anti PD-1 or anti-PD-L1 agent therapy, pembrolizumab and/or any of its excipients, or an agent directed to another stimulatory or co-inhibitory T-cell receptor (e.g., CTLA-4, CD134 [OX40], CD137) that caused permanent discontinuation of the agent, or that were grade 4 in severity or have not resolved to grade ≤1.
Cannot have received: agonists or antagonists of IL-2, IL-4, IL-7, IL-8, IL-9, IL-12, IL-15, IL-18, IL-21 or IL-27
Prior exposure to drugs that are agonists or antagonists of IL-2, IL-4, IL-7, IL-8, IL-9, IL-12, IL-15, IL-18, IL-21 or IL-27 prior to ICF signature.
Lab requirements
Blood counts
adequate organ function during screening and prior to first SOT201 dose
Kidney function
adequate organ function during screening and prior to first SOT201 dose
Liver function
adequate organ function during screening and prior to first SOT201 dose
Organ function: Have adequate organ function during screening and prior to first SOT201 dose.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- MD Anderson Cancer Center · Houston, Texas
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