Clinical trials: sponsored by Philogen S.p.A.
Prostate Cancer
A Phase I Study to Evaluate the Safety and Dosimetry of Imaging With 68Ga-OncoACP3 in Prostate Cancer
The aim of this study is to assess the safety and dosimetry of imaging with [68Ga]Ga-OncoACP3 in patients with prostate cancer.
- Trial name
- SWAP (NCT07600554)
- Testing
- [68Ga]Ga-OncoACP3
- Where
- 2 sites in Italy
- Volunteers
- 20 people
- Sponsor
- Philogen S.p.A.
FAP
A Study to Evaluate the Safety and Preliminary Signs of Efficacy of [177Lu]Lu-OncoFAP-23 Alone or in Combination With L19-IL2 as a Treatment of Metastatic FAP-positive Solid Tumors
The aim of this study is to assess the safety of [177Lu]Lu-OncoFAP-23 alone or in combination with L19-IL2 for the treatment of advanced/metastatic Fibroblast Activation Protein (FAP)-positive solid tumors and to establish a…
- Trial name
- TheraTri (NCT06640413)
- Testing
- [177Lu]Lu-OncoFAP-23, L19IL2
- Where
- 4 sites in Italy
- Volunteers
- 56 people
- Sponsor
- Philogen S.p.A.
Rheumatoid Arthritis (RA)
A Study of F8IL10 Intra-articular Treatment in Rheumatoid Arthritis
The aim of this study is to evaluate the safety of F8IL10 when administered by intra-articular injection and to determine the maximum tolerated dose (MTD) in order to establish the recommended dose (RD) in patients with Reumatoid…
- Trial name
- DekaJoint (NCT07245992)
- Testing
- F8IL10
- Where
- 2 sites in Italy
- Volunteers
- 54 people
- Sponsor
- Philogen S.p.A.
Advanced Solid Tumor, Metastatic Solid Tumor
Safety and Early Signs of Efficacy of IL12-L19L19.
The purpose of this study is to describe the safety, tolerability and early signs of efficacy of the antibody-cytokine fusion protein IL12-L19L19 in patients with advanced or metastatic solid carcinomas, after previous immune…
- Trial name
- DODEKA (NCT04471987)
- Testing
- IL12-L19L19
- Where
- 11 sites in Germany, Italy and 1 more
- Volunteers
- 80 people
- Sponsor
- Philogen S.p.A.
Melanoma Stage III, Melanoma Stage IV
Study of the Efficacy of Intratumoral L19IL2 or L19TNF or L19IL2/L19TNF, in Combination With Pembrolizumab, in Unresectable Melanoma Patients
The trial aims to evaluate the efficacy of single agent L19IL2, single agent L19TNF, and combination L19IL2+L19TNF given concurrently with anti-PD1 therapy compared to historical control of anti-PD-1 re-challenge alone for…
- Trial name
- INTACT/MeRCI (NCT06284590)
- Testing
- L19IL2, L19TNF, L19IL2/L19TNF
- Where
- 7 sites in United States, Germany and 1 more
- Volunteers
- 162 people
- Sponsor
- Philogen S.p.A.
Locally Advanced Basal Cell Carcinoma
L19IL2 or L19TNF or L19IL2/TNF in Patients With Basal Cell Carcinoma (BCC)
Open label, randomized study in patients with LaBCC not eligible or refusing surgery or radiation therapy according to the evaluation of a local interdisciplinary tumor board.
- Trial name
- NCT07227350
- Testing
- L19IL2, L19TNF, L19IL2/L19TNF
- Where
- 18 sites in United States, Germany and 3 more
- Volunteers
- 180 people
- Sponsor
- Philogen S.p.A.
Locally Advanced Cutaneous Squamous Cell Carcinoma
L19IL2/L19TNF in Patients With Cutaneous Squamous Cell Carcinoma
Open-label, single-arm, multicenter study in patients with locally advanced, histologically confirmed Cutaneous Squamous Cell Carcinoma (LacSCC) amenable to intratumoral injection, who have progressed on or are intolerant to…
- Trial name
- NCT07228442
- Testing
- L19IL2/L19TNF
- Where
- 19 sites in United States, Germany and 3 more
- Volunteers
- 92 people
- Sponsor
- Philogen S.p.A.
Locally Advanced Basal Cell Carcinoma
L19IL2/TNF in Patients With Basal Cell Carcinoma
Open-label, single-arm, multicentre study in patients with locally advanced BCC amenable to intratumoral injection, who have progressed on or are intolerant to systemic therapy as determined by a local multidisciplinary tumor…
- Trial name
- NCT07227870
- Testing
- L19IL2/L19TNF
- Where
- 18 sites in United States, Germany and 3 more
- Volunteers
- 92 people
- Sponsor
- Philogen S.p.A.
Renal Carcinoma Metastatic, Pancreatic Adenocarcinoma Metastatic
A Phase I Study to Evaluate the Safety and Efficacy of L19IL2 in Combination With Ruxolitinib in Patients With Advanced Solid Tumors
This trial aims to address unmet medical needs in advanced solid tumors, specifically metastatic clear cell renal carcinoma, locally advanced or metastatic pancreatic adenocarcinoma, and metastatic colorectal adenocarcinoma.
- Conditions
- Renal Carcinoma Metastatic, Pancreatic Adenocarcinoma Metastatic, Pancreatic Adenocarcinoma, Metastatic Colorectal Carcinoma (mCRC)
- Trial name
- NCT07566897
- Testing
- L19IL2, Ruxolitinib
- Where
- Italy
- Volunteers
- 96 people
- Sponsor
- Philogen S.p.A.
Glioblastoma
A Study With L19TNF in Combination With Lomustine in Patients With Glioblastoma at Progression or Recurrence
The trial aims to collect safety, efficacy, exposure, dose- response, pharmacokinetic and pharmacodynamic information of the combination of L19TNF and lomustine at different dose levels in patients with Glioblastoma at…
- Trial name
- GLIOSTELLA (NCT06336291)
- Testing
- L19TNF, Lomustine
- Where
- 9 sites in United States
- Volunteers
- 90 people
- Sponsor
- Philogen S.p.A.
Clear Cell Renal Cell Carcinoma (ccRCC)
A Study to Evaluate the Safety and Dosimetry of 68Ga-OncoCAIX in Patients With CAIX-positive Cancer
Phase I and multicenter study to evaluate the safety and dosimetry of 68Ga-OncoCAIX in patients with clear cell renal cell carcinoma.
- Trial name
- OncoCAIX (NCT06840548)
- Testing
- [68Ga]Ga-OncoCAIX
- Where
- 3 sites in Italy
- Volunteers
- 20 people
- Sponsor
- Philogen S.p.A.
Prostate Cancer, Prostate Cancer Metastatic Disease
A Study to Evaluate the Safety and Dosimetry of 68Ga-OncoACP3 in Patients With Prostate Cancer
The aim of this study is to assess the safety and dosimetry of [68Ga]Ga-OncoACP3 in patients with prostate cancer.
- Conditions
- Prostate Cancer, Prostate Cancer Metastatic Disease, PSA Level Greater Than 0.2
- Trial name
- OncoACP-3 (NCT06840535)
- Testing
- [68Ga]Ga-OncoACP3
- Where
- 3 sites in Italy
- Volunteers
- 20 people
- Sponsor
- Philogen S.p.A.
Melanoma Stage IIIB, Melanoma Stage IIIC
Efficacy of Daromun Neoadjuvant Intratumoral Treatment in Clinical Stage IIIB/C/D Melanoma Patients
The trial aims to evaluate the efficacy of Daromun neoadjuvant treatment followed by surgery and adjuvant therapy to improve in a statistically significant manner the recurrence-free survival (RFS) of Stage IIIB/C/D melanoma…
- Conditions
- Melanoma Stage IIIB, Melanoma Stage IIIC, Melanoma Stage IIID
- Trial name
- NeoDREAM (NCT03567889)
- Testing
- Daromun, Surgery, Adjuvant therapy
- Where
- 37 sites in United States, Spain and 1 more
- Volunteers
- 186 people
- Sponsor
- Philogen S.p.A.
Rheumatoid Arthritis
Safety and Preliminary Signs of Efficacy of F8IL10 for Intra-articular Treatment
This multicenter, prospective Phase I study is aimed at testing the safety of F8IL10 via i.a. administration once every 4 weeks over 8 weeks in patients with RA who, despite treatment with stable doses (at least 3 months) of…
- Trial name
- DekaJoint (NCT05622175)
- Testing
- F8IL10
- Sponsor
- Philogen S.p.A.
Glioma
A Study to Evaluate the Safety and Efficacy of L19TNF With Alkylating Chemotherapy for Patients With Recurrent IDH-mutant Astrocytoma or Oligodendroglioma
The purpose of this study is to explore the safety and efficacy of the antibody-cytokine fusion protein L19TNF alone or in combination with alkylating chemotherapy in patients with recurrent IDH mutant glioma.
- Trial name
- IMAGLIO (NCT07120984)
- Testing
- L19TNF, L19TNF and TMZ, L19TNF and CCNU
- Volunteers
- 52 people
- Sponsor
- Philogen S.p.A.
Soft Tissue Sarcoma
Efficacy and Safety of L19TNF in Previously Treated Patients with Advanced Stage or Metastatic Soft-tissue Sarcoma
Open label, randomized, controlled phase II study preceded by a safety run-in part in subjects with advanced or metastatic soft-tissue sarcoma.
- Trial name
- FLASH (NCT04733183)
- Testing
- Dacarbazine, onfekafusp alfa
- Where
- 23 sites in France, Germany and 3 more
- Volunteers
- 98 people
- Sponsor
- Philogen S.p.A.
Breast Cancer, Colorectal Cancer
A Study to Evaluate the Safety and Dosimetry of 68Ga-labelled OncoFAP Derivatives in Solid Tumors
The primary objectives of this trial are to evaluate the safety and dosimetry of [68Ga]Ga-OncoFAP for detection/imaging of solid tumors.
- Conditions
- Breast Cancer, Colorectal Cancer, Oesophageal Cancer, Pancreas Adenocarcinoma
- Trial name
- FAPrimo (NCT05784597)
- Testing
- [68Ga]Ga-OncoFAP administration
- Where
- 5 sites in Italy
- Volunteers
- 18 people
- Sponsor
- Philogen S.p.A.
Malignant Melanoma
Neoadjuvant L19IL2/L19TNF- Pivotal Study
Phase III, open-label, randomized, controlled multi-center study of the efficacy of L19IL2/L19TNF neoadjuvant intratumoral treatment in Stage III B/C melanoma patients.
- Trial name
- Pivotal (NCT02938299)
- Testing
- L19IL2 + L19TNF, Surgery
- Where
- 22 sites in France, Germany and 2 more
- Volunteers
- 214 people
- Sponsor
- Philogen S.p.A.
Glioblastoma
Safety and Efficacy of Different Administration Sequences of L19TNF With Lomustine in Glioblastoma at First Progression
Open label phase I study in subjects with glioblastoma at first progression to explore two different administration schedules of lomustine for the combination with L19TNF (ARM 1 and ARM 2).
- Trial name
- GLIOASTRA (NCT05304663)
- Testing
- Onfekafusp alfa, Lomustine
- Sponsor
- Philogen S.p.A.
Glioblastoma
A Study to Evaluate Safety and Efficacy of L19TNF Plus Lomustine in Patients With Glioblastoma at First Progression
Glioblastomas are the most common and most aggressive primary brain tumors in adults. The prognosis is poor despite multimodal therapy with surgery, radiotherapy and chemotherapy. Therefore, novel treatments are urgently needed.
- Trial name
- GLIOSTAR (NCT04573192)
- Testing
- L19TNF, Lomustine
- Where
- 15 sites in France, Germany and 2 more
- Volunteers
- 142 people
- Sponsor
- Philogen S.p.A.