Trial reportJournal of cancer research and clinical oncology2013
Phase I/II study of the tumour-targeting human monoclonal antibody-cytokine fusion protein L19-TNF in patients with advanced solid tumours.
Trial report in Journal of cancer research and clinical oncology, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 55 papers.
What it found
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The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
55 citing papers in PubMed, 100 citations in OpenAlex.
- A phase II study of the L19IL2 immunocytokine in combination with dacarbazine in advanced metastatic melanoma patients.Cancer immunology, immunotherapy : CII · 2019Trial
- Imaging-guided optimization of biodistribution and antitumor efficacy of L19-based immunocytokines.Translational oncology · 2026Article
- Exploring the mechanism of fibronectin extra domain B in the tumor microenvironment and implications for targeted immunotherapy and diagnostics (Review).Molecular medicine reports · 2025Review
- Immunocytokines in cancer immunotherapy: opportunities and challenges.Frontiers in oncology · 2025Review
- Stimulating the Antitumor Immune Response Using Immunocytokines: A Preclinical and Clinical Overview.Pharmaceutics · 2024Review
- A novel strategy to generate immunocytokines with activity-on-demand using small molecule inhibitors.EMBO molecular medicine · 2024Article
- Tumor-Homing Antibody-Cytokine Fusions for Cancer Therapy.OncoTargets and therapy · 2024Review
- Targeted Cytokine Delivery for Cancer Treatment: Engineering and Biological Effects.Pharmaceutics · 2023Review
- Selection of a PD-1 blocking antibody from a novel fully human phage display library.Protein science : a publication of the Protein Society · 2022Article
- Generation andJournal for immunotherapy of cancer · 2022Article
- Molecular ZIP codes in targeted drug delivery.Proceedings of the National Academy of Sciences of the United States of America · 2022Review
- The use of supercytokines, immunocytokines, engager cytokines, and other synthetic cytokines in immunotherapy.Cellular & molecular immunology · 2022Review
- Development of immunotherapy for high-grade gliomas: Overcoming the immunosuppressive tumor microenvironment.Frontiers in medicine · 2022Review
- A comprehensive comparison between camelid nanobodies and single chain variable fragments.Biomarker research · 2021Review
- Article
- An Attenuated Targeted-TNF Localizes to Tumors In Vivo and Regains Activity at the Site of Disease.International journal of molecular sciences · 2021Article
- Review
- Utilizing Immunocytokines for Cancer Therapy.Antibodies (Basel, Switzerland) · 2021Review
- An engineered 4-1BBL fusion protein with "activity on demand".Proceedings of the National Academy of Sciences of the United States of America · 2020Article
- Evolution ofInternational journal of molecular sciences · 2020Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
12 authors at 6 institutions in 2 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
purposeL19-TNF is an armed antibody that selectively targets human TNF to extra domain B-fibronectin on tumour blood vessels. We performed a phase I/II first-in-man trial with L19-TNF monotherapy in metastatic solid cancer patients to study safety and signs of clinical activity.
methodsSix cohorts of patients were treated with increasing (1.3-13 μg/kg) doses of intravenous L19-TNF on day 1, 3, and 5 of repeated 3-weekly cycles, and 12 colorectal cancer patients were treated at 13 μg/kg. PK, antibody formation, changes in lymphocyte subsets, 5-HIAA plasma levels as well as safety and clinical activity were analysed.
resultsThirty-four patients received at least one L19-TNF dose. The serum half-life of L19-TNF at 13 μg/kg was 33.6 min, and maximum peak serum concentration was 73.14 μg/L. Mild chills, nausea and vomiting but no haemato- or unexpected toxicity were observed. Grade 3 lumbar pain in bone metastasis was the only dose-limiting toxicity found in one patient. Objective tumour responses were not detected. Transient stable disease occurred in 19 of 31 evaluable patients.
conclusionsIntravenous L19-TNF on day 1, 3, and 5 of a 3-weekly schedule was safe up to 13 μg/kg, but did not result in objective tumour responses. The maximally tolerated dose (MTD) was not reached, allowing for further dose escalation of L19-TNF possibly in combination with chemotherapy.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.