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NCT06163391 · ClinicalTrials.gov registry record · Phase 1

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

A Phase 1 study of Advanced Solid Tumor and Metastatic Solid Tumor, sponsored by SOTIO Biotech.

Recruiting
Registry status
Phase 1
Development phase
40
Enrollment target
7
Study locations

NCT06163391 is a Phase 1 study of Advanced Solid Tumor and Metastatic Solid Tumor that is actively recruiting participants, run by SOTIO Biotech. The registered enrollment target is 40 participants, below the 193-participant average among 189 other Advanced Solid Tumor trials with a reported enrollment target (79% lower). The trial reports 7 study locations across 4 states.

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The verdict

NCT06163391, a Phase 1 study of Advanced Solid Tumor and Metastatic Solid Tumor, is actively recruiting participants, sponsored by SOTIO Biotech.

RECRUITING
Registry status
Phase 1
Development phase
40 participants
Enrollment target
7
Study locations

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 Studied

Advanced Solid Tumor Metastatic Solid Tumor

Interventions

  • DRUG SOT201

Study Locations (7)

Other

  • Masarykův Onkologický Ústav - Brno
  • Fakultni Nemocnice Olomouc (FNOL) - Onkologicka Klinika - Olomouc
  • Institut Gustave Roussy - Paris
  • Hospital Universitari Vall d'Hebron - Vall d'Hebron Institut d'Oncologia (VHIO) - Barcelona

Texas

  • MD Anderson Cancer Center - Houston

Antwerp

  • Universitair Ziekenhuis Antwerpen (UZA) - Edegem

Brussels Capital

  • Institut Jules Bordet - Anderlecht

Trial Details

FieldValue
Enrollment Target 40 participants
Start Date 2024-05-01
Est. Completion 2026-10
Phase Phase 1

Sponsor

SOTIO Biotech

3 total trials

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What the Registry Record Tells You About NCT06163391

The ClinicalTrials.gov registry entry for NCT06163391 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 40 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 193-participant average among 189 other Advanced Solid Tumor trials with a reported enrollment target (79% lower). The listed sponsor is SOTIO Biotech, which has 3 total studies on file at ClinicalTrials.gov.

The record links to 2 conditions, with Advanced Solid Tumor appearing as the primary indexed condition, and to 1 intervention - of which SOT201 is the first listed.

NCT06163391 reports 7 study locations spanning 4 distinct geographic areas - top geographies include Other, Texas, Antwerp.

Frequently Asked Questions

What is clinical trial NCT06163391 about?

NCT06163391 is a clinical study titled "A Study to Assess Safety and Efficacy of SOT201 in Patients With Advanced/Metastatic Cancer". 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 ev...

What is the current status of trial NCT06163391?

This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 40 participants. The study started on 2024-05-01. Estimated completion is 2026-10.

What conditions does trial NCT06163391 study?

This clinical trial studies the following conditions: Advanced Solid Tumor, Metastatic Solid Tumor.

What interventions are being tested in trial NCT06163391?

The interventions under investigation include: SOT201 (DRUG).

Who is sponsoring clinical trial NCT06163391?

This trial is sponsored by SOTIO Biotech, which has 3 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT06163391 being conducted?

This trial has 7 study locations across Texas, Antwerp, Brussels Capital. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.