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

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. According to ClinicalTrials.gov, the official US trial registry.

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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

Primary Outcome

A TEAE is defined as an AE that started or worsened at or after the start of trial treatment Presence of TEAEs, SAEs, and lab abnormalities, according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0

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
SOTIO Biotech

3 total trials

What NCT06163391 shows while recruiting

NCT06163391 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 40 participants, a relatively small participant target, below the 193-participant average among 189 other Advanced Solid Tumor trials with a reported enrollment target (79% lower).

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 lists 7 locations in 4 states (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.

Learn More About Clinical Trials

Similar trials for Advanced Solid Tumor

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT06163391's enrollment target sits among peer trials

40 170th of 189 higher than 20 of 189 other Advanced Solid Tumor trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Advanced Solid Tumor trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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More recruiting context for NCT06163391

Source: ClinicalTrials.gov NCT06163391, the US trial registry maintained by the National Library of Medicine. NCT06163391 (small enrollment · multi site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.