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

Part of paid clinical trials in Houston, Texas.

Sponsor
SOTIO Biotech AG
Study ID
NCT06163391
Phase
PHASE1
Status
Recruiting
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Conditions

  • Advanced Solid Tumor
  • Metastatic Solid Tumor

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • SOT201 — DRUG
    intravenous infusion

Study Details

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

Key Dates

Start date
May 1, 2024
Status verified
Jun 2025
Primary completion
Oct 31, 2026
Completion
Oct 31, 2026

Study Design

Enrollment
40 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: SOT201
    SOT201 will be administered intravenously once every 21 days

Primary Outcome Measure

Number and percentages of participants with treatment-emergent adverse events (TEAEs) [ Time Frame: from patient signing the ICF up to 90 (+7) days after the last dose of SOT201, assessed approximately up to 3 years ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
MD Anderson Cancer CenterHoustonTexas77030
Aung Naing, MD, FACP
[email protected]
713-563-3885

Find similar trials in Houston, TX

By research site
MD Anderson Cancer Center· Houston, TX

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