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

Phase 1

Active, not recruiting

• Conditions: Advanced Soft-tissue Sarcoma
• Interventions: Drug: LB-100 plus Doxorrubicin; Drug: Doxorubicin

• Registration Number: NCT05809830
• Lead Sponsor: Grupo Espanol de Investigacion en Sarcomas

Brief 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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-03-27
• Study First Submitted QC: 2023-04-11
• Study First Posted: 2023-04-12
• Study Start: 2023-05-29
• Status Verified: 2025-02
• Last Update Submitted: 2025-03-18
• Last Update Posted: 2025-03-21
• Primary Completion: 2025-06-20
• Study Completion: 2026-05-08

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 152

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
LB-100 plus doxorubicin	LB-100 plus Doxorrubicin	* LB-100 will be administered during the first 3 days of each cycle (days 1, 2, and 3) at RP2D as a 2-hour intravenous infusion (with 500 mL of physiological saline solution), every 3 weeks (21-day cycles until progression or intolerance). * Doxorubicin will be administered only once (day 1) of each cycle at RP2D as a 20-minute infusion after completion of LB-100, every 3 weeks (up to a maximum of 6 x 21-day cycles).
Doxorubicin alone	Doxorubicin	Control: Doxorubicin will be administered only once (day 1) of each cycle at RP2D as a 20-minute infusion every 3 weeks (up to a maximum of 6 x 21-day cycles).

Primary Outcome Measures

Name	Time	Method
Maximun Tolerated Dose (MTD) (Phase I)	After six months	The MTD of LB-100 in combination with doxorubicin will be determined by assessing adverse events according to CTCAE v5.0.
Progression-free survival (PFS) (Phase II)	After two years	Efficacy measured by median PFS according to RECIST v1.1

Secondary Outcome Measures

Name	Time	Method
Adverse Events (Phase I and II)	Between six months and two years	Safety profile/Toxicity assessed by adverse events related to study drugs
Overall Response Rate (ORR) (Phase I and II)	Between six months and two years	Efficacy measured by the ORR, which is defined as the number of subjects with a Best Overall Response (BOR) of Complete Response (CR) or Partial Response (PR) divided by the number of response evaluable subjects.
EORTC QLQ-C30 questionnaire (Phase I and II)	Between six months and two years	Quality of life assessed by using the EORTC QLQ-C30 questionnaire.
Progression-free survival (PFS) (Phase I)	After six months	Efficacy measured by median PFS according to RECIST v1.1
Overall survival (OS) (Phase I and II)	Between six months and two years	Censored on the last date a subject was known to be alive

Trial Locations

Locations (6)

Hospital de la Santa Creu i Sant Pau; 🇪🇸 Barcelona, Cataluña, Spain

Hospital Clínico Universitario de Valencia; 🇪🇸 Valencia, Comunidad Valenciana, Spain

Hospital Clínico San Carlos; 🇪🇸 Madrid, Spain

Hospital Fundación Jiménez Díaz; 🇪🇸 Madrid, Spain

Hospital Universitario La Paz; 🇪🇸 Madrid, Spain

Hospital Clínico Universitario Virgen de la Arrixaca; 🇪🇸 Murcia, Spain