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Clinical trials
catalyst calendar across sponsors →Studies where PHIL.MI is the lead sponsor, as filed with ClinicalTrials.gov. Completion dates are the sponsor's own projected windows and are revised as a study runs. Active studies first, then completed and stopped — newest readout first within each.
49 interventional
government filings 180d: none disclosed
| Study | Phase | Status | Interventions | Conditions | Enrollment | Primary completion | Readout in | Updated |
|---|---|---|---|---|---|---|---|---|
| L19IL2 or L19TNF or L19IL2/TNF in Patients With Basal Cell Carcinoma (BCC)NCT07227350Best Overall Response RateRandomized · Open-label · Treatment | Phase 2 | Recruiting | Drug: L19IL2, L19TNF, L19IL2/L19TNF | Locally Advanced Basal Cell Carcinoma | 180 | Feb 2031 | ≤ 1,653 d | 2026-07-31 |
| L19IL2/TNF in Patients With Basal Cell CarcinomaNCT07227870Best Overall Response Rate (BORR)Open-label · Treatment | Phase 2 | Recruiting | Drug: L19IL2/L19TNF | Locally Advanced Basal Cell Carcinoma | 92 | Feb 2031 | ≤ 1,653 d | 2026-07-21 |
| L19IL2/L19TNF in Patients With Cutaneous Squamous Cell CarcinomaNCT07228442Overall Response Rate (BORR)Open-label · Treatment | Phase 2 | Recruiting | Drug: L19IL2/L19TNF | Locally Advanced Cutaneous Squamous Cell Carcinoma | 92 | Feb 2031 | ≤ 1,653 d | 2026-07-24 |
| A Phase I Study to Evaluate the Safety and Efficacy of L19IL2 in Combination With Ruxolitinib in Patients With Advanced Solid TumorsNCT07566897STEP A and STEP B: DLTNon-randomized · Open-label · Treatment | Phase 1 | Not yet recruiting | Drug: L19IL2, Ruxolitinib | Renal Carcinoma Metastatic, Pancreatic Adenocarcinoma Metastatic, Pancreatic Adenocarcinoma, Metastatic Colorectal Carcinoma (mCRC) | 96 | Dec 2029 | ≤ 1,229 d | 2026-05-05 |
| A Study to Evaluate the Safety and Efficacy of L19TNF With Alkylating Chemotherapy for Patients With Recurrent IDH-mutant Astrocytoma or OligodendrogliomaNCT07120984Progression-free survival (PFS)Non-randomized · Open-label · Treatment | Phase 2 | Not yet recruiting | Biological: L19TNF, L19TNF and TMZ, L19TNF and CCNU, L19TNF monotherapy, L19TNF and TMZ in recurrent astrocytoma, L19TNF and CCNU in recurrent astrocytoma, L19TNF monothery in recurrent oligodendroglioma | Glioma | 52 | 2029-01-30 | in 894 d | 2025-08-13 |
| A Study of F8IL10 Intra-articular Treatment in Rheumatoid ArthritisNCT07245992DLTOpen-label · Treatment | Phase 1 | Recruiting | Drug: F8IL10 | Rheumatoid Arthritis (RA) | 42 | 2028-09-30 | in 772 d | 2026-08-11 |
| Study of the Efficacy of Intratumoral L19IL2 or L19TNF or L19IL2/L19TNF, in Combination with Pembrolizumab, in Unresectable Melanoma PatientsNCT06284590Confirmed Objective Response Rate (ORR)Randomized · Open-label · Treatment | Phase 2 | Recruiting | Drug: L19IL2, L19TNF, L19IL2/L19TNF, KEYTRUDA® | Melanoma Stage III, Melanoma Stage IV | 162 | Jul 2028 | ≤ 711 d | 2024-10-26 |
| 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 TumorsNCT06640413Dose Limiting ToxicityNon-randomized · Open-label · Treatment | Phase 1 | Recruiting | Drug: [177Lu]Lu-OncoFAP-23, L19IL2 | FAP | 56 | 2028-05-31 | in 650 d | 2026-01-14 |
| Efficacy of Daromun Neoadjuvant Intratumoral Treatment in Clinical Stage IIIB/C/D Melanoma PatientsNCT03567889Recurrence Free Survival (RFS)Randomized · Open-label · Treatment | Phase 3 | Recruiting | Drug: Daromun, Adjuvant therapy · Procedure: Surgery | Melanoma Stage IIIB, Melanoma Stage IIIC, Melanoma Stage IIID | 186 | Dec 2027 | ≤ 498 d | 2025-12-17 |
| A Phase I Study to Evaluate the Safety and Dosimetry of Imaging With 68Ga-OncoACP3 in Prostate CancerNCT07600554Adverse events (AEs) and Serious Adverse Events (SAEs)Non-randomized · Open-label · Diagnostic | Phase 1 | Recruiting | Drug: [68Ga]Ga-OncoACP3 | Prostate Cancer | 20 | Dec 2027 | ≤ 498 d | 2026-06-10 |
| Safety and Early Signs of Efficacy of IL12-L19L19.NCT04471987For Part I: DLTOpen-label · Treatment | Phase 1 | Recruiting | Drug: IL12-L19L19, IL12-L19L19 | Advanced Solid Tumor, Metastatic Solid Tumor | 80 | Dec 2026 | ≤ 133 d | 2026-01-14 |
| Safety and Efficacy of L19TNF Plus Temozolomide Chemoradiotherapy in Patients With Newly Diagnosed GlioblastomaNCT04443010For Phase 1: DLTNon-randomized · Open-label · Treatment | Phase 1/2 | Recruiting | Drug: Onfekafusp alfa, Temozolomide | Glioblastoma | 226 | Oct 2026 | ≤ 72 d | 2023-10-10 |
| A Study With L19TNF in Combination With Lomustine in Patients With Glioblastoma at Progression or RecurrenceNCT06336291Adverse EventsRandomized · Open-label · Treatment | Phase 2 | Active, not recruiting | Drug: L19TNF, L19TNF, L19TNF, Lomustine, Lomustine | Glioblastoma | 90 | Jun 2026 | — | 2026-04-21 |
| Efficacy and Safety of L19TNF in Previously Treated Patients with Advanced Stage or Metastatic Soft-tissue SarcomaNCT04733183Progression-free survival (PFS)Randomized · Open-label · Treatment | Phase 2 | Active, not recruiting | Drug: Dacarbazine, onfekafusp alfa | Soft Tissue Sarcoma | 98 | Dec 2025 | — | 2025-01-27 |
| Neoadjuvant L19IL2/L19TNF- Pivotal StudyNCT02938299Recurrence-free survival (RFS) rateRandomized · Open-label · Treatment | Phase 3 | Active, not recruiting | Drug: L19IL2 + L19TNF · Procedure: Surgery | Malignant Melanoma | 214 | Oct 2024 | — | 2024-09-19 |
| A Study Comparing the Efficacy of L19TNF+Doxorubicin vs Doxorubicin Alone as First-line Therapy in Patients With Advanced or Metastatic Soft Tissue SarcomaNCT04650984Median Progression free survival (mPFS)Randomized · Open-label · Treatment | Phase 3 | Unknown status | Drug: Onfekafusp alfa, Doxorubicin | Soft Tissue Sarcoma | 102 | 2025-12-31 | — | 2024-04-08 |
| Safety and Preliminary Signs of Efficacy of F8IL10 for Intra-articular TreatmentNCT05622175MTDOpen-label · Treatment | Phase 1 | Withdrawnsponsor's stated reason: Study redesigned and registered under NCT07245992 (Protocol n° PH-F8IL10INTRA-03/24) | Drug: F8IL10 | Rheumatoid Arthritis | 0 | 2025-12-31 | — | 2025-12-02 |
| A Study to Evaluate the Safety and Dosimetry of 68Ga-OncoCAIX in Patients With CAIX-positive CancerNCT06840548Cohort A: Dosimetry - Effective dose equivalent (mSv)Non-randomized · Open-label · Diagnostic | Phase 1 | Completed | Drug: [68Ga]Ga-OncoCAIX | Clear Cell Renal Cell Carcinoma (ccRCC) | 20 | 2025-11-28actual | — | 2026-01-13 |
| A Study to Evaluate the Safety and Dosimetry of 68Ga-OncoACP3 in Patients With Prostate CancerNCT06840535Cohort A: Dosimetry - Effective dose equivalent (mSv)Non-randomized · Open-label · Diagnostic | Phase 1 | Completed | Drug: [68Ga]Ga-OncoACP3 | Prostate Cancer, Prostate Cancer Metastatic Disease, PSA Level Greater Than 0.2 | 20 | 2025-10-03actual | — | 2026-01-06 |
| A Study to Evaluate Safety and Efficacy of L19TNF Plus Lomustine in Patients With Glioblastoma at First ProgressionNCT04573192For Phase 1: DLTRandomized · Open-label · Treatment | Phase 1/2 | Unknown status | Drug: L19TNF, Lomustine | Glioblastoma | 142 | Mar 2025 | — | 2024-04-08 |
| Treatment of Metastatic Soft Tissue Sarcoma (STS) Patients (FIBROSARC USA)NCT03420014Progression free survival (PFS)Randomized · Open-label · Treatment | Phase 2 | Unknown status | Drug: Doxorubicin · Combination product: L19TNF plus doxorubicin | Leiomyosarcoma | 114 | Dec 2024 | — | 2023-10-10 |
| Dose Finding Study of L19TNF and Doxorubicin in Patients With STSNCT04032964Number and type of Adverse events (AE)Open-label · Treatment | Phase 1 | Unknown status | Drug: L19TNF, DOXORUBICIN | Soft Tissue Sarcoma | 2 | Dec 2024 | — | 2024-04-08 |
| Safety and Efficacy of Different Administration Sequences of L19TNF With Lomustine in Glioblastoma at First ProgressionNCT05304663Safety of L19TNF plus lomustine with different administration sequencesNon-randomized · Open-label · Treatment | Phase 1 | Withdrawnsponsor's stated reason: The Sponsor had no further plan for the study in object | Drug: Onfekafusp alfa, Lomustine | Glioblastoma | 0 | 2024-12-31 | — | 2024-04-08 |
| A Study to Evaluate the Safety and Dosimetry of 68Ga-labelled OncoFAP Derivatives in Solid TumorsNCT05784597Safety (AE)Non-randomized · Open-label · Diagnostic | Phase 1 | Completed | Drug: [68Ga]Ga-OncoFAP administration | Breast Cancer, Colorectal Cancer, Oesophageal Cancer, Pancreas Adenocarcinoma | 18 | 2024-10-21actual | — | 2024-11-15 |
| Intratumoral Administration of Daromun in Non-melanoma Skin Cancer PatientsNCT04362722Efficacy of L19IL2/L19TNF in CROpen-label · Treatment | Phase 2 | Unknown status | Drug: L19IL2 +L19TNF | Carcinoma, Basal Cell, Carcinoma, Cutaneous Squamous Cell | 40 | Sep 2024 | — | 2023-10-10 |
| L19IL2/L19TNF in Skin Cancer PatientsNCT05329792Confirmed best overall response rate (BORR)Open-label · Treatment | Phase 2 | Unknown status | Drug: L19IL2/L19TNF | BCC - Basal Cell Carcinoma, SCC - Squamous Cell Carcinoma, Merkel Cell Carcinoma, Keratoacanthoma of Skin, Malignant Adnexal Tumors of the Skin (MATS), Tumors From Cutaneous T-cell Lymphoma (CTCL), Kaposi Sarcoma | 70 | Jun 2024 | — | 2023-10-06 |
| 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)NCT02957019Number of patients with adverse events that are related to treatment and classified as DLTs for each administered dosage - phase I studyOpen-label · Treatment | Phase 1/2 | Terminatedsponsor's stated reason: Slow progression due to difficulties in finding eligible patients. Competitive clinical trials with innovative agents and new approved products leaddefinitive stop. | Drug: L19-IL2 - Ph I, L19-IL2 at RD - Ph II, Rituximab | Diffuse Large B-cell Lymphoma (DLBCL) | 6 | Sep 2023actual | — | 2023-10-10 |
| 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 TransplantationNCT02957032Dose limiting toxicity (DLT)Open-label · Treatment | Phase 1 | Terminatedsponsor's stated reason: New agents for the same indication impacted on patients' recruitment | Drug: F16IL2, cytarabine | Acute Myeloid Leukemia, Relapsed, Adult | 30 | 2023-09-29actual | — | 2023-10-10 |
| Safety and Efficacy of L19TNF in Patients With Isocitrate Dehydrogenase (IDH) Wildtype WHO Grade III / IV Glioma at First RelapseNCT03779230Occurrence of Dose Limiting Toxicity (DLT)Open-label · Treatment | Phase 1/2 | Completed | Drug: L19TNF | Glioma of Brain | 20 | 2023-06-27actual | — | 2023-06-29 |
| F16IL2 in Combination With Nivolumab in Patients With Non-small Cell Lung CancerNCT05468294Number of patients with adverse events that are related to treatment and classified as DLTs for each administered dosage - phase I studyOpen-label · Treatment | Phase 1/2 | Unknown status | Drug: F16IL2, Nivolumab, fixed dose | Non-small Cell Lung Cancer (NSCLC) | 3 | 2021-12-31actual | — | 2022-07-21 |
| Trial to Find and Investigate a Safe Dose of F16IL2 and BI 836858 in Patients With AML Relapse After Allogeneic Hematopoietic Stem Cell TransplantationNCT03207191Number of patients with adverse events that are related to treatment and classified as DLTs for each administered dosageOpen-label · Treatment | Phase 1 | Completed | Drug: F16IL2, BI 836858 | Acute Myeloid Leukemia (AML) Relapse | 15 | 2020-03-26actual | — | 2022-04-20 |
| A Randomized, Placebo-controlled Phase II Clinical Trial to Evaluate the Safety and Efficacy of F8IL10 (Dekavil) in Patients With Active RA Receiving MTXNCT02270632Change from baseline in DAS28-CRPscoreRandomized · Triple-masked · Treatment | Phase 2 | Terminatedsponsor's stated reason: Approvals of new agents for the same indication have significantly slowed down the recruitment in this trial making the prosecution of the present investigation extremely difficult. | Drug: F8IL10, MTX, Placebo | Rheumatoid Arthritis | 27 | Apr 2019actual | — | 2023-06-12 |
| L19TNFα in Combination With Doxorubicin in Patients With Advanced Solid TumoursNCT02076620Dose limiting toxicity (DLT)Open-label · Treatment | Phase 1 | Completed | Drug: L19TNFα, Doxorubicin | Advanced Solid Tumors Amenable to Anthracycline Therapy, Sarcoma, Breast Cancer, Lung Carcinomas, and Gynecological Cancer Amenable to Anthracycline Therapy | 29 | 2018-01-25actual | — | 2022-04-04 |
| Combination Therapy of F8IL10 and Methotrexate in Rheumatoid Arthritis PatientsNCT02076659Number of patients with adverse events that are related to treatment and classified as DLTs for each administered dosageOpen-label · Treatment | Phase 1 | Completed | Drug: F8IL10, Methotrexate | Rheumatoid Arthritis | 36 | Apr 2017actual | — | 2018-05-18 |
| F16IL2 Plus Paclitaxel in Metastatic Merkel Cell CarcinomaNCT02054884Efficacy of F16IL2 in combination with paclitaxel vs. paclitaxel monotherapy (RECIST v1.1, irRC)Randomized · Open-label · Treatment | Phase 2 | Terminatedsponsor's stated reason: Lack of enrollment | Drug: Arm A: F16IL2 in combination with paclitaxel, Arm B: Paclitaxel | Merkel Cell Carcinoma | 13 | 2016-12-31actual | — | 2018-05-18 |
| 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 MelanomaNCT02076646Phase I: maximum tolerated dose (MTD) and recommended dose (RD) of L19IL2Randomized · Open-label · Treatment | Phase 1/2 | Unknown status | Drug: L19IL2 - Ph I, L19IL2 at RD - Ph II, DTIC | Metastatic Melanoma Stage IV | 96 | 2016-05-17actual | — | 2022-04-14 |
| Intratumoral Administration of L19IL2/L19TNFNCT02076633Rate of patients with complete response (CR) of L19IL2 treated Index/Non-Index lesions at week 12.Open-label · Treatment | Phase 2 | Completed | Drug: L19IL2+L19TNF | Malignant Melanoma, Skin | 21 | May 2015actual | — | 2015-05-27 |
| Combination Therapy of L19IL2 and Gemcitabine in Advanced Pancreatic Cancer PatientsNCT01198522Maximum tolerated dose and the preliminary tolerability profile.Non-randomized · Open-label · Treatment | Phase 1 | Terminatedsponsor's stated reason: lack of recruitment | Drug: L19IL2 monoclonal antibody-cytokine fusion protein in combination with gemcitabine | Pancreatic Cancer Patients Diagnosed With Locally Advanced or Metastatic Pancreatic Cancer Not Amenable to Curative Surgical Resection | 28 | Nov 2014actual | — | 2022-04-15 |
| Combination Therapy of F16IL2 and Paclitaxel in Solid Tumour PatientsNCT01134250To establish the maximum tolerated dose (MTD) and the recommended dose (RD) of F16IL2 when administered in combination with paclitaxel (Phase I).Open-label · Treatment | Phase 1/2 | Completed | Drug: F16IL2 in combination with paclitaxel | Solid Tumor, Breast Cancer, Metastatic Melanoma, Non-small Cell Lung Cancer (NSCLC) | 48 | 2014-04-07actual | — | 2022-04-15 |
| Intratumoral Application of L19IL2 in Patients With Malignant MelanomaNCT01253096Rate of patients with complete response (CR) of L19IL2 treated Index/Non-Index lesions at week 12 .Open-label · Treatment | Phase 2 | Completed | Drug: Intratumoral injections of L19IL2 | Malignant Melanoma | 25 | Sep 2013actual | — | 2014-11-20 |
| Clinical Study Phase II of L19IL2 in Combination With Dacarbazine in Patients With Metastatic MelanomaNCT01055522To establish the recommended dose (RD) of L19IL2 when administered in combination with a fixed dose of DacarbazineRandomized · Open-label · Treatment | Phase 2 | Terminated | Drug: Arm 1: L19IL2 + Dacarbazine, Arm 3: Dacarbazine, ARM 2: L19IL2 + Dacarbazine | Metastatic Melanoma | 102 | Feb 2013actual | — | 2014-02-25 |
| 131I-L19SIP Radioimmunotherapy (RIT) in Combination With External Beam Radiation in Patients With Multiple Brain Metastases From Solid TumorsNCT01125085Uptake of 131I-L19SIP or 124I-L19SIPNon-randomized · Open-label · Treatment | Phase 2 | Completed | Radiation: 131I-L19SIP Radioimmunotherapy (RIT) in Combination With Whole Brain Radiation Therapy (WBRT) | Brain Metastases From Solid Tumors | 32 | Oct 2012actual | — | 2014-02-25 |
| Combination Therapy of F16IL2 and Doxorubicin in Solid Tumour PatientsNCT01131364Maximum tolerated and recommended dose (MTD) (RD)Open-label · Treatment | Phase 1/2 | Terminated | Drug: F16IL2 in combination with doxorubicin | Advanced Solid Tumor, Breast Cancer | 29 | Mar 2012actual | — | 2014-02-25 |
| A Dose Finding and Efficacy Study of the Tumour Targeting Human 131I-F16SIP Monoclonal Antibody in Patients With CancerNCT01240720Phase I: Maximum tolerated DoseNon-randomized · Open-label · Treatment | Phase 1/2 | Completed | Drug: 131I-F16SIP Radioimmunotherapy (RIT) | Cancer | 65 | Nov 2011actual | — | 2014-02-25 |
| 131I-L19SIP Radioimmunotherapy Combined With Radiochemotherapy in Patients With Locally-advanced Non Small Cell Lung Cancer (NSCLC)NCT01124812Uptake of 131I-L19SIP or 124I-L19SIPNon-randomized · Open-label · Treatment | Phase 1 | Terminated | Other: 131I-L19SIP Radioimmunotherapy (RIT) in Combination With External Beam Radiotherapy (EBRT) and Concurrent Chemotherapy | Non Small Cell Lung Cancer | 3 | Aug 2011actual | — | 2012-10-26 |
| L19TNFα in Patients With Advanced Solid TumorsNCT01253837Phase I: Determination of the Maximum Tolerated Dose (MTD) and Recommended Dose (RD)Open-label · Treatment | Phase 1/2 | Completed | Drug: L19TNFa | Solid Tumors, Colorectal Cancer | 34 | May 2011actual | — | 2011-09-23 |
| Phase 1 Dose-finding Study of L19TNFα Plus Melphalan Using Isolated Inferior Limb Perfusion (ILP) in Subjects With Intransit Stage III/IV MelanomaNCT01213732Safety and TolerabilityNon-randomized · Open-label · Treatment | Phase 1 | Completed | Other: Isolated inferior limb perfusion | Patients With Intransit Stage III/IV Melanoma | 19 | Mar 2011actual | — | 2022-04-15 |
| Radioimmunotherapy With 131I-L19SIP in Patients With CancerNCT01242943Phase I: Maximum tolerated dose (MTD)Non-randomized · Open-label · Treatment | Phase 1/2 | Terminatedsponsor's stated reason: With the determination of the RD and a well established understanding of the safety and tolerability profile, the main endpoints of the study have been met. | Drug: 131I-L19SIP Radioimmunotherapy (RIT) | Patients With Cancer | 34 | Feb 2011actual | — | 2011-11-22 |
| A Dose Finding Pharmacokinetic Study of the Tumour-targeting Human L19IL2 Monoclonal Antibody-Cytokine Fusion Protein in Patients With Advanced Solid TumoursNCT01058538To determine the maximum tolerated dose (MTD) and recommended dose (RD) of the human L19IL2 fusion-cytokine.Open-label · Treatment | Phase 1/2 | Completed | Drug: L19IL2 | Advanced Solid Tumours | 33 | Apr 2008actual | — | 2014-02-25 |
Primary completion is the date the sponsor filed with the registry — their own projection, revised whenever they revise it, unless the row is marked actual.
Source: ClinicalTrials.gov, retrieved 2026-08-19