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A Study to Assess Safety and Efficacy of SOT201 in Patients With Advanced/Metastatic Cancer

NCT06163391 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2025-06-29

No results posted yet for this study

Summary

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

Conditions

  • Advanced Solid Tumor
  • Metastatic Solid Tumor

Interventions

DRUG

SOT201

intravenous infusion

Sponsors & Collaborators

  • SOTIO Biotech AG

    lead INDUSTRY

Principal Investigators

  • Aung Naing, MD, FCAP · M.D. Anderson Cancer Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-05-01
Primary Completion
2026-10-31
Completion
2026-10-31
FDA Drug
Yes

Countries

  • United States
  • Belgium
  • Czechia
  • France
  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06163391 on ClinicalTrials.gov