Overview

Randomized Phase I/II Trial of LB-100 Plus Doxorubicin vs Doxorubicin Alone of Advanced Soft Tissue Sarcomas

Status:
Not yet recruiting

Trial end date:
2026-05-08

Target enrollment:

Participant gender:

Summary

A Phase I dose-finding stage for the LB-100 plus doxorubicin combination is planned for an initial set of 9-18 patients (21-day cycles). After that, in the Phase II part, patients will be randomized (ratio 1:1) to either the experimental arm (LB-100 plus doxorubicin combination) or the control arm (doxorubicin alone) to, comparatively, evaluate the efficacy of the LB-100 plus doxorubicin combination vs. doxorubicin alone

Phase:

Phase 1/Phase 2

Details

Lead Sponsor:

Grupo Espanol de Investigacion en Sarcomas

Treatments:

Doxorubicin
LB100