A Phase III study comparing the efficacy of the combination of doxorubicin and the tumor-targeting human antibody-cytokine fusion protein L19TNF to doxorubicin alone as first-line therapy in patients with advanced or metastatic soft tissue sarcoma

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2024-512789-32-00

Acronym

PH-L19TNFDOX2-03/16

Enrollment

118

Registered

2024-05-03

Start date

2017-10-09

Completion date

Unknown

Last updated

2025-01-11

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

Conditions

Unresectable or metastatic soft tissue sarcoma

Brief summary

The following efficacy endpoint will be considered: − Progression-free survival (PFS)

Detailed description

To assess the safety profile of L19TNF combined with doxorubicin. The following safety endpoints will be considered: − Adverse Events (AEs) assessment based on CTCAE v.4.03. − Standard laboratory (haematology, biochemistry and urinalysis) parameters. − Physical examination findings including assessment of vital signs and physical measurements.

Interventions

DRUGFibromun

DRUGDoxorubicin 2 mg/ml Solution for Injection.

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
The following efficacy endpoint will be considered: − Progression-free survival (PFS)	—

Secondary

Measure	Time frame
To assess the safety profile of L19TNF combined with doxorubicin. The following safety endpoints will be considered: − Adverse Events (AEs) assessment based on CTCAE v.4.03. − Standard laboratory (haematology, biochemistry and urinalysis) parameters. − Physical examination findings including assessment of vital signs and physical measurements.	—

Countries

France, Germany, Italy, Poland, Spain

Outcome results

None listed

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