A randomized study to investigate the efficacy and safety of the tumor-targeting human antibody-cytokine fusion protein L19TNF in previously treated patients with advanced stage or metastatic soft-tissue sarcoma

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2024-512704-20-00

Acronym

PH-L19TNFSARC-03/18

Enrollment

Registered

2024-05-01

Start date

2020-06-22

Completion date

Unknown

Last updated

2025-10-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Unresectable and/or metastatic soft-tissue sarcoma after failure of at least two prior systemic therapy regimens.

Brief summary

The following primary efficacy endpoint will be considered: − Progression-free survival (PFS) in according to RECIST v.1.1

Detailed description

The following key secondary endpoint will be considered: − Overall survival (OS)

Interventions

DRUGFibromun

DRUGDacarbazine medac 1000 mg

DRUGpowder for solution for infusion

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
The following primary efficacy endpoint will be considered: − Progression-free survival (PFS) in according to RECIST v.1.1	—

Secondary

Measure	Time frame
The following key secondary endpoint will be considered: − Overall survival (OS)	—

Countries

France, Germany, Italy, Poland, Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026