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A Study to Assess Safety and Efficacy of SOT106 in Patients With LRRC15-positive Advanced Unresectable or Metastatic Osteosarcoma or Soft Tissue Sarcoma

NCT07801222 · Status: NOT_YET_RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 70

Last updated 2026-09-03

No results posted yet for this study

Summary

SOT106 is a special cancer medicine designed to find and kill certain cancer cells that carry a marker called LRRC15, while causing less harm to healthy cells. The study consists of two parts, Part A and Part B. The goal of Part A is to collect information about SOT106, understand its effects, and see whether it is safe and well tolerated at different dose levels. Part B of the study collects information on which of the two selected safe dose levels chosen in Part A gives the best balance between benefit and risk.

Conditions

  • Osteosarcoma Metastatic
  • Soft Tissue Sarcoma (STS)
  • Osteosarcoma, Advanced

Interventions

BIOLOGICAL

SOT106

SOT106 is a LRRC15-directed monoclonal antibody conjugated to a linker-payload, Monomethyl auristatin E

Sponsors & Collaborators

  • SOTIO Biotech a.s.

    lead INDUSTRY

Principal Investigators

  • Silvia Stacchiotti, M.D. · S.C. Oncologia Medica 2, Tumori Mesenchimali e Rari, Fondazione IRCCS, Istituto Nazionale dei Tumori

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-09-30
Primary Completion
2029-01-19
Completion
2030-05-21
FDA Drug
Yes

Countries

  • Moldova

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 NCT07801222 on ClinicalTrials.gov