Clinical trials: sponsored by Philogen S.p.A.
Soft Tissue Sarcoma
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 present study is an open-label, randomized, controlled, two-arm multi-center study of the efficacy of L19TNF treatment in combination with doxorubicin versus doxorubicin alone in advanced or metastatic soft-tissue sarcoma…
- Trial name
- FIBROSARC (NCT04650984)
- Testing
- Onfekafusp alfa, Doxorubicin
- Where
- 28 sites in France, Germany and 3 more
- Volunteers
- 102 people
- Sponsor
- Philogen S.p.A.
Soft Tissue Sarcoma
Dose Finding Study of L19TNF and Doxorubicin in Patients With STS
The study is aimed at evaluating the safety of L19TNF in combination with the most appropriate dose of doxorubicin.
- Trial name
- DOXO75 (NCT04032964)
- Testing
- L19TNF, DOXORUBICIN
- Where
- United States
- Volunteers
- 2 people
- Sponsor
- Philogen S.p.A.
Glioblastoma
Safety and Efficacy of L19TNF Plus Temozolomide Chemoradiotherapy in Patients With Newly Diagnosed Glioblastoma
The purpose of this study is to explore the safety profile and establish a recommended dose (RD) for phase II of the antibody-cytokine fusion protein L19TNF plus standard TMZ chemoradiotherapy in patients with newly diagnosed…
- Trial name
- GLIOSUN (NCT04443010)
- Testing
- Onfekafusp alfa, Temozolomide
- Where
- Switzerland
- Volunteers
- 226 people
- Sponsor
- Philogen S.p.A.
Carcinoma, Basal Cell, Carcinoma, Cutaneous Squamous Cell
Intratumoral Administration of Daromun in Non-melanoma Skin Cancer Patients
This clinical phase II study is designed to investigate the efficacy of intratumorally administered L19IL2/L19TNF in patients with injectable lesions of BCC or cSCC.
- Trial name
- DUNCAN (NCT04362722)
- Testing
- L19IL2 +L19TNF
- Where
- 11 sites in Germany, Poland and 1 more
- Volunteers
- 40 people
- Sponsor
- Philogen S.p.A.
Diffuse Large B-cell Lymphoma (DLBCL)
A Phase I/II Study of the Tumor-targeting Human L19-IL2 Monoclonal Antibody-cytokine Fusion Protein in Combination With Rituximab in Relapsed or Refractory Diffuse Large B-cell Lymphoma (DLBCL)
Phase I/II, open-label, multicenter, prospective study.
- Trial name
- NCT02957019
- Testing
- L19-IL2 - Ph I, L19-IL2 at RD - Ph II, Rituximab
- Where
- Germany
- Volunteers
- 6 people
- Sponsor
- Philogen S.p.A.
Acute Myeloid Leukemia, Relapsed, Adult
A Study of the Tumor-targeting Human F16IL2 Monoclonal Antibody-cytokine Fusion Protein in Combination With Very Low-dose Cytarabine in Patients With AML Relapse After Allogeneic Hematopoietic Stem Cell Transplantation
Phase I, open label, non-randomized, multicenter, prospective dose escalation study of F16IL2 in combination with very low-dose cytarabine in subjects with acute myeloid leukemia relapse after allogeneic hematopoietic stem cell…
- Trial name
- NCT02957032
- Testing
- F16IL2, cytarabine
- Where
- Germany
- Volunteers
- 30 people
- Sponsor
- Philogen S.p.A.
Leiomyosarcoma
Treatment of Metastatic Soft Tissue Sarcoma (STS) Patients (FIBROSARC USA)
The present study is an open-label, randomized, controlled, two-arm multi-center study of the efficacy of L19TNF treatment in combination with doxorubicin versus doxorubicin alone in metastatic leiomyosarcoma patients.
- Trial name
- FIBROSARC US (NCT03420014)
- Testing
- Doxorubicin, L19TNF plus doxorubicin
- Where
- 8 sites in United States
- Volunteers
- 114 people
- Sponsor
- Philogen S.p.A.
BCC - Basal Cell Carcinoma, SCC - Squamous Cell Carcinoma
L19IL2/L19TNF in Skin Cancer Patients
Phase II, open label, multicentric, proof-of-principle basket trial in patients with malignant tumors of the skin amenable to intratumoral injection, and in a curative or neoadjuvant or palliative intention.
- Conditions
- BCC - Basal Cell Carcinoma, SCC - Squamous Cell Carcinoma, Merkel Cell Carcinoma, Keratoacanthoma of Skin
- Trial name
- IntriNSiC (NCT05329792)
- Testing
- L19IL2/L19TNF
- Where
- 14 sites in France, Italy and 1 more
- Volunteers
- 70 people
- Sponsor
- Philogen S.p.A.
Glioma of Brain
Safety and Efficacy of L19TNF in Patients With Isocitrate Dehydrogenase (IDH) Wildtype WHO Grade III / IV Glioma at First Relapse
Open label, non-randomized, mono-center Phase I/II study in subjects with IDH-wildtype WHO grade III / IV glioma at first relapse.
- Trial name
- GLIOMOON (NCT03779230)
- Testing
- L19TNF
- Where
- 3 sites in Switzerland
- Volunteers
- 20 people
- Sponsor
- Philogen S.p.A.
Rheumatoid Arthritis
A Randomized, Placebo-controlled Phase II Clinical Trial to Evaluate the Safety and Efficacy of F8IL10 (Dekavil) in Patients With Active RA Receiving MTX
A multicenter, randomized, parallel assignment, double blind, placebo-controlled, safety/efficacy phase II study of two different dosages of subcutaneous F8IL10 in patients with active rheumatoid arthritis receiving MTX.
- Trial name
- NCT02270632
- Testing
- F8IL10, MTX
- Where
- 8 sites in Germany, Italy and 1 more
- Volunteers
- 27 people
- Sponsor
- Philogen S.p.A.
Non-small Cell Lung Cancer (NSCLC)
F16IL2 in Combination With Nivolumab in Patients With Non-small Cell Lung Cancer
Prospective, open label, non-randomized, phase I/IIb study of F16IL2 in combination with Nivolumab.
- Trial name
- Nivokin (NCT05468294)
- Testing
- F16IL2, Nivolumab, fixed dose
- Where
- Switzerland
- Volunteers
- 3 people
- Sponsor
- Philogen S.p.A.
Acute Myeloid Leukemia (AML) Relapse
Trial to Find and Investigate a Safe Dose of F16IL2 and BI 836858 in Patients With AML Relapse After Allogeneic Hematopoietic Stem Cell Transplantation
Phase I, open label, single arm, non-randomized, multicenter, prospective dose escalation study in subjects with acute myeloid leukemia relapse after allogeneic hematopoietic stem cell transplantation (alloHSCT).
- Trial name
- PHIBI (NCT03207191)
- Testing
- F16IL2, BI 836858
- Where
- 2 sites in Germany
- Volunteers
- 15 people
- Sponsor
- Philogen S.p.A.
Patients With Intransit Stage III/IV Melanoma
Phase 1 Dose-finding Study of L19TNFα Plus Melphalan Using Isolated Inferior Limb Perfusion (ILP) in Subjects With Intransit Stage III/IV Melanoma
In this study the recombinant human fusion protein L19TNFα will be associated in ILP with the standard treatment with melphalan 10mg/l limb volume in subjects affected by stage III/IV limb melanoma.
- Trial name
- NCT01213732
- Testing
- Isolated inferior limb perfusion
- Where
- 2 sites in Italy
- Volunteers
- 19 people
- Sponsor
- Philogen S.p.A.
Solid Tumor, Breast Cancer
Combination Therapy of F16IL2 and Paclitaxel in Solid Tumour Patients
This Phase Ib/II study is an open label, multicenter study. The study is divided in two parts: Phase I: an open-label, dose escalation study of F16IL2 in combination with paclitaxel for patients with solid tumours, bladder…
- Conditions
- Solid Tumor, Breast Cancer, Metastatic Melanoma, Non-small Cell Lung Cancer (NSCLC)
- Trial name
- NCT01134250
- Testing
- F16IL2 in combination with paclitaxel
- Where
- 5 sites in Italy
- Volunteers
- 48 people
- Sponsor
- Philogen S.p.A.
Pancreatic Cancer Patients Diagnosed With Locally Advanced or Metastatic Pancreatic Cancer Not Amenable to Curative Surgical Resection
Combination Therapy of L19IL2 and Gemcitabine in Advanced Pancreatic Cancer Patients
Systemic treatment for advanced, non-resectable pancreatic cancer still having minimal impact on the survival of patients. Even with the application of more potent gemcitabine-based regimens, survival of more than 1 year is…
- Trial name
- NCT01198522
- Testing
- L19IL2 monoclonal antibody-cytokine fusion protein in combination with gemcitabine
- Where
- 5 sites in Germany, Italy
- Volunteers
- 28 people
- Sponsor
- Philogen S.p.A.
Metastatic Melanoma Stage IV
A Phase I/II Dose Escalation Study of the Tumor-targeting Human L19-IL2 Monoclonal Antibody-cytokine Fusion Protein in Combination With Dacarbazine for Patients With Metastatic Melanoma
A prospective, open-label, multi-center, Phase I/II study of L19IL2 in combination with Dacarbazine in patients with metastatic melanoma.
- Trial name
- NCT02076646
- Testing
- L19IL2 - Ph I, L19IL2 at RD - Ph II, DTIC
- Where
- 2 sites in Germany, Italy
- Volunteers
- 96 people
- Sponsor
- Philogen S.p.A.
Advanced Solid Tumors Amenable to Anthracycline Therapy, Sarcoma, Breast Cancer, Lung Carcinomas, and Gynecological Cancer Amenable to Anthracycline Therapy
L19TNFα in Combination With Doxorubicin in Patients With Advanced Solid Tumours
Prospective, open-label, non randomized, dose escalation study that will be conducted in sequential cohorts of patients.
- Trial name
- NCT02076620
- Testing
- L19TNFα, Doxorubicin
- Where
- 2 sites in Germany, Italy
- Volunteers
- 29 people
- Sponsor
- Philogen S.p.A.
Rheumatoid Arthritis
Combination Therapy of F8IL10 and Methotrexate in Rheumatoid Arthritis Patients
Phase I, multicenter, open-label, dose escalation study to test the efficacy and safety of F8IL10 and methotrexate when given as a combination in rheumatoid arthritis patients.
- Trial name
- NCT02076659
- Testing
- F8IL10, Methotrexate
- Where
- 5 sites in Italy
- Volunteers
- 36 people
- Sponsor
- Philogen S.p.A.
Merkel Cell Carcinoma
F16IL2 Plus Paclitaxel in Metastatic Merkel Cell Carcinoma
There is no standard treatment for Merkel cell carcinoma(MCC), as no randomized trials have been conducted to establish standard of care.
- Trial name
- NCT02054884
- Testing
- Arm A: F16IL2 in combination with paclitaxel, Arm B: Paclitaxel
- Where
- 8 sites in Austria, Denmark and 4 more
- Volunteers
- 13 people
- Sponsor
- Philogen S.p.A.
Malignant Melanoma, Skin
Intratumoral Administration of L19IL2/L19TNF
This Phase II study is an uncontrolled, multicenter, prospective study for patients with malignant melanoma of the skin in clinical stage III or stage IV M1a.
- Trial name
- NCT02076633
- Testing
- L19IL2+L19TNF
- Where
- 2 sites in Italy
- Volunteers
- 21 people
- Sponsor
- Philogen S.p.A.