Primary Outcome Measures The analysis of the primary efficacy endpoint will be conducted in all eligible patients, based on the disease control rate (DCR) at 12 weeks according to mRECIST 1.1 for mesothelioma, which was defined as the proportion of patients with compete response (CR), partial response (PR) or stable[…]
Status
The Diagnostic Accuracy and Clinical Value of FAPI PET in Pleural Mesothelioma (FAPI-PM)
Primary Outcome Measures The diagnostic performance (sensitivity, specificity, positive predicative value, negative predicative value, and overall diagnostic accuracy – all parameters in %). in of FAPI PET compared to routine imaging modalities, including FDG PET/CT, in suspected PM lesions. Secondary Outcome Measures Calculate the proportion of patients where the location[…]
The Diagnostic Accuracy and Clinical Value of FAPI PET in Pleural Mesothelioma (FAPI-PM)
Primary Outcome Measures Calculate the proportion of patients where the location of the intended pleural biopsy is altered due to FAPI PET/CT replacing FDG PET/CT. Secondary Outcome Measures Compare the cancer stage (IASCL 9th edition TNM-classification) as determined by FAPI PET/CT compared to conventional imaging (including FDG PET/CT) at primary[…]
Study of ISM6331 in Participants With Advanced/Metastatic Malignant Mesothelioma or Other Solid Tumors
This is a Phase 1, open-label, multicenter, FIH study to evaluate the safety, tolerability, recommended Phase 2 dose (RP2D), PK/PD, and preliminary anti-tumor activity of ISM6331 in participants with advanced or metastatic malignant mesothelioma or other solid tumors. The study consists of two parts, a dose escalation part (Part 1) and a dose selection optimization part (Part 2).
Sintilimab, Bevacizumab, Pemetrexed, and Cisplatin for Unresectable MPeM
To explore the efficacy and safety of sintilimab, bevacizumab combined with pemetrexed and cisplatin in the treatment of malignant peritoneal mesothelioma, and to explore the biomarkers related to efficacy or safety.
New Preclinical and Clinical Approaches to Mesothelioma
This study protocol involves the coordination between UO1 (IRCCS San Raffaele Hospital) and UO2 (Istituto Nazionale Tumori di Napoli – IRCCS G. Pascale) to explore the role of HMGB1 and CXCR4 in cancer treatment and metastasis. UO1 focuses on the role of HMGB1 in inflammation, mesothelioma progression, and tissue repair, as well as developing, in future, possible HMGB1 inhibitors for cancer therapy. UO2 specializes in CXCR4’s role in cancer, developing CXCR4 antagonists, and tracking CXCR4-dependent metastasis. The hypothesis is that targeting HMGB1 and CXCR4 pathways will inhibit tumor progression and metastasis, enhancing anti-tumor immunity and improving therapeutic outcomes in cancer.
A Phase 1 Study to Investigate 14C-bemcentinib Following Single Oral Administration in Healthy Male Subjects (8479217)
The aims of this Study are to determine:
How much of the Study Drug (bemcentinib) ends up in urine and faeces
How much of the Study Drug and its breakdown products get into the bloodstream
The breakdown products (metabolites) of the Study Drug
The safety of the Study Drug and any side effects that might be associated with it.
Ga-68 FAPI PET Before Immunotherapy (FAPBI)
It is aimed to evaluate FAP expression and its success in predicting treatment response before immunotherapy used in the treatment of malignant mesothelioma with Ga68 FAPI PET/CT imaging, which allows in vivo evaluation of FAP expression, which is thought to be associated with immunosuppression and resistance to immunotherapy.
A Study of VET3-TGI in Patients With Solid Tumors (STEALTH-001)
VET3-TGI is an oncolytic immunotherapy designed to treat advanced cancers. VET3-TGI has not been given to human patients yet, and the current study is designed to find a safe and effective dose of VET3-TGI when administered by direct injection into tumor(s) (called an intratumoral injection) or when given intravenously (into the vein) both alone and in combination with pembrolizumab in patients with solid tumors (STEALTH-001).
Study of Cadonilimab Combined With Chemotherapy in Recurrent / Refractory Pleural Mesothelioma
This is a multicenter, single-arm, phase II clinical study to evaluate the safety and efficacy of Cadonilimab combined with gemcitabine, or vinorelbine, or pemetrexed in the treatment of patients with recurrent / refractory pleural mesothelioma.
