Biotechnology compans conducts a Study Comparing the Efficacy of L19TNF+Doxorubicin vs Doxorubicin Alone as First-line Therapy in Patients With Advanced or Metastatic Soft Tissue Sarcoma
The company Philogen S.p.A is commencing recruitment for the clinical trial of the A Study Comparing the Efficacy of L19TNF+Doxorubicin vs Doxorubicin Alone as First-line Therapy in Patients With Advanced or Metastatic Soft Tissue Sarcoma.
The condition is Soft Tissue Sarcoma.
A new clinical trial is recruiting patients in the following locations: Germany.
The trial officially began on the November 29, 2017 and is planned to complete on December 31, 2024.
The primary objective of the trial is to evaluate if L19TNF in combination with doxorubicin given for unresectable or metastatic soft tissue sarcoma improves efficacy measured as progression-free survival, as compared to doxorubicin alone.
The population that can be enrolled into this study includes:
- Patients aged 18-75 years.
- Patients must have histological evidence of advanced unresectable and/or metastatic high-grade soft tissue sarcoma (grade 2 - 3 according to the FNLCC grading system) not amenable to curative treatment with surgery or radiotherapy.
- Patients must have at least one unidimensionally measurable lesion by computed tomography as defined by RECIST criteria 1.1. This lesion should not have been irradiated during previous treatments.
- Life expectancy of at least 3 months.
- Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2.
- Documented negative test for HIV-HBV-HCV. For HBV serology: the determination of HBsAg, anti-HBsAg-Ab and anti-HBCAg-Ab is required. In patients with serology documenting previous exposure to HBV (i.e., anti-HBs Ab with no history of vaccination and/or anti-HBc Ab), negative serum HBV-DNA is required. For HCV: HCV-RNA or HCV antibody test. Subjects with a positive test for HCV antibody but no detection of HCV-RNA indicating no current infection are eligible.
and others.
The link to the complete study profile: https://ichgcp.net/clinical-trials-registry/NCT04650984
