Trials / Completed
CompletedNCT02076620
L19TNFα in Combination With Doxorubicin in Patients With Advanced Solid Tumours
Phase I Study of the Tumor-targeting Human L19TNFα Monoclonal Antibody-cytokine Fusion Protein in Combination With Doxorubicin in Patients With Advanced Solid Tumours
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 29 (actual)
- Sponsor
- Philogen S.p.A. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
Prospective, open-label, non randomized, dose escalation study that will be conducted in sequential cohorts of patients.
Detailed description
In the clinical trial 3-6 patients will be assigned to L19TNFalfa at one of the following sequential dose levels (10.4 µg/kg, 13 µg/kg and 17 µg/kg) in combination with a fixed dose of doxorubicin. The RD will be defined following a traditional 3+3 design. The dose escalation will continue until the MTD is found, that is until at least two patients among a cohort of three to six patients experience a dose limiting toxicity (DLT).
Conditions
- Advanced Solid Tumors Amenable to Anthracycline Therapy
- Sarcoma, Breast Cancer, Lung Carcinomas, and Gynecological Cancer Amenable to Anthracycline Therapy
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | L19TNFα | L19TNFα will be administered as a 2 hours i.v. infusion on days 1, 3, and 5 of each 3-week cycle. |
| DRUG | Doxorubicin | Doxorubicin will be administered as a 15 minutes i.v. infusion on day 1 of each 3-week cycle prior L19TNFα administration. |
Timeline
- Start date
- 2013-01-16
- Primary completion
- 2018-01-25
- Completion
- 2018-01-25
- First posted
- 2014-03-03
- Last updated
- 2022-04-04
Locations
2 sites across 2 countries: Germany, Italy
Source: ClinicalTrials.gov record NCT02076620. Inclusion in this directory is not an endorsement.