NCT05809830

Phase I/II of LB-100 Plus Doxorubicin vs. Doxorubicin Alone in First Line of Advanced Soft Tissue Sarcomas

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

• Status: Active Not Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 152 (estimated)
• Sponsor: Grupo Espanol de Investigacion en Sarcomas · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Conditions

• Advanced Soft-tissue Sarcoma

Interventions

Type	Name	Description
DRUG	LB-100 plus Doxorrubicin	In Phase one the intervention will be LB-100 plus Doxorrubicin. The experimental arm in Phase II will also be LB-100 plus Doxorrubicin
DRUG	Doxorubicin	The control arm in Phase II will be Doxorrubicin alone

Timeline

• Start date: 2023-05-29
• Primary completion: 2025-06-20
• Completion: 2026-05-08
• First posted: 2023-04-12
• Last updated: 2025-03-21

Locations

6 sites across 1 country: Spain

Regulatory

• FDA-regulated drug study