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L19TNFα in Patients With Advanced Solid Tumors

NCT01253837 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 34

Last updated 2011-09-23

No results posted yet for this study

Summary

The recombinant human fusion protein L19TNFα was created with the intention to overcome the systemic toxicity of TNFα by directly targeting it to tumor tissues. Tumor-targeted L19TNFα would result in high and sustained intralesional bioactive TNFα concentrations.

Conditions

Interventions

DRUG

L19TNFa

Phase I: Sequential assignment of Patient cohorts to one of six dose levels of L19TNFa: 1.3, 2.6, 5.2, 7.8, 10.4, 13.0 µg/kg. Phase II: The Recommended Dose (RD) of 13.0 µg/kg of L19TNFα determined in Phase I. Schedule: Infusions of L19TNFα on days 1, 3 and 5 of each 21-day cycle. Patients may remain on treatment for a maximum of six 21-day cycles.

Sponsors & Collaborators

  • InnoPharma Inc.

    collaborator INDUSTRY

  • Eudax S.r.l.

    collaborator INDUSTRY

  • Philogen S.p.A.

    lead INDUSTRY

Principal Investigators

  • Filippo De Braud, Dr. · European Istitute of Oncology Milan (Italy)

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-09-30
Primary Completion
2011-05-31
Completion
2011-09-30

Countries

  • Italy

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01253837 on ClinicalTrials.gov