Clinical Trials Logo
  1. Home
  2. Advanced Soft Tissue Sarcoma
  3. NCT05809830

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

Advanced Soft-tissue Sarcoma Clinical Trial

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

Clinical Trial 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

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05809830
Study type Interventional
Source Grupo Espanol de Investigacion en Sarcomas
Contact Patricio Ledesma
Phone +34 971 439 900
Email ensayos@sofpromed.com
Status Recruiting
Phase Phase 1/Phase 2
Start date May 29, 2023
Completion date May 8, 2026
View Details
See also
  Status Clinical Trial Phase
Recruiting NCT05043649 - Camsirubicin + Pegfilgrastim to Determine MTD in ASTS Phase 1
Recruiting NCT05146440 - Multicohort Trial of Different Schemes of PM14 in Monotherapy and in Combination With Radiotherapy in Soft Tissue Sarcomas and Other Solid Tumor Phase 1/Phase 2
Recruiting NCT05620693 - Study of NY-ESO-1 TCR-T in Advanced Soft Tissue Sarcoma N/A
Not yet recruiting NCT06367075 - A Trial of Cadonilimab With Adriamycin in Patients With Advanced Soft Tissue Sarcoma Phase 2
Recruiting NCT04874311 - Bintrafusp Alfa and Doxorubicin Hydrochloride in Treating Patients With Advanced Sarcoma Phase 2
Recruiting NCT05876715 - LINNOVATE: Lurbinectedin, Ipilimumab and Nivolumab for Soft Tissue Sarcoma Phase 1/Phase 2
Recruiting NCT04757337 - Comparison of Oral Cyclophosphamide vs Doxorubicin in ≥65 Years Old Advanced or Metastatic Soft Tissue Sarcoma Patients Phase 3
Recruiting NCT04705818 - Combining Epigenetic And Immune Therapy to Beat Cancer. Phase 2
Terminated NCT05154630 - Study on Tolerability and Pharmacokinetics of TQB2858 Injection in Subjects With Advanced Malignant Tumors Phase 1/Phase 2
Recruiting NCT05099666 - Lurbinectedin + Doxorubicin In Leiomyosarcoma Phase 1/Phase 2
Completed NCT03022448 - Geriatric Assessmen of Elderly "Unsuited" Patients Receiving Trabectedin in First Line Treatment For Advanced Soft Tissue Sarcomas (STS)
Recruiting NCT04204941 - Tazemetostat in Combination With Doxorubicin as Frontline Therapy for Advanced Epithelioid Sarcoma Phase 3
Recruiting NCT05182164 - Combination of Pembrolizumab and Cabozantinib in Patients With Advanced Sarcomas Phase 2
Recruiting NCT05180695 - HDM201 and Pazopanib in Patients With P53 Wild-type Advanced/Metastatic Soft Tissue Sarcomas Phase 1/Phase 2
Terminated NCT04780464 - A 3 Arm Randomized Study on Health-related QoL of Elderly Patients With Advanced Soft Tissue Sarcoma Phase 3