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

ClinicalTrials.gov ID: NCT06163391

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ClinicalTrials.gov public records Last synced Nov 14, 2026, 2:38 PM EST

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Official title

A Multicenter, Open-label, Phase 1 Study to Evaluate the Safety and Preliminary Efficacy of SOT201 in Patients With Advanced/Metastatic Solid Tumors

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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

Study identification

NCT ID: NCT06163391
Recruitment status: Active, not recruiting
Study type: Interventional
Phase: Phase 1
Lead sponsor: SOTIO Biotech AG; Industry
Enrollment: 40 participants

Conditions and interventions

Conditions

Interventions

SOT201 Drug

Drug

Eligibility (public fields only)

Age range: 18 Years and older
Sex: All
Healthy volunteers: Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date: May 1, 2024 (Actual)
Primary completion: Dec 2026 (Estimated)
Completion: Mar 2027 (Estimated)
Last update posted: Oct 14, 2026

2024 – 2027

United States locations

U.S. sites: 1
U.S. states: 1
U.S. cities: 1

Facility	City	State	ZIP	Site status
MD Anderson Cancer Center	Houston	Texas	77030	—

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 5 non-U.S. sites.

About this trial record page

What this page shows: Public field values for ClinicalTrials.gov record NCT06163391, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do: No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from: Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh: Last update posted Oct 14, 2026 · Synced Nov 14, 2026