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Study of DPPG2-TSL-DOX Combined With Hyperthermia in Soft Tissue Sarcoma

NCT05858710 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 8

Last updated 2025-07-28

No results posted yet for this study

Summary

This study aims to explore a new therapeutic approach for advanced soft tissue sarcoma (STS) by investigating the safety, tolerability, and maximum tolerated dose (MTD)/highest tolerated dose (HTD) of DPPG2-TSL-DOX combined with regional hyperthermia (RHT) in patients who have been pre-treated with anthracycline, e.g. doxorubicin (DOX).

Conditions

  • Sarcoma, Soft Tissue

Interventions

DRUG

DPPG2-TSL-DOX

DPPG2-TSL-DOX is a thermosensitive liposomal formulation of doxorubicin.

DRUG

Dexrazoxane

For cardioprotection of participants.

Sponsors & Collaborators

  • Thermosome GmbH

    lead INDUSTRY

Principal Investigators

  • Peter Reichardt, PD Dr. · Helios Klinikum Berlin-Buch GmbH

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-04-19
Primary Completion
2025-01-30
Completion
2025-05-28

Countries

  • Germany

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 NCT05858710 on ClinicalTrials.gov