Clinical Research Directory

A Study of IDE892 as Monotherapy and Combination in MTAP-deleted Advanced Solid Tumors

This is a multicenter clinical study to evaluate the safety, efficacy, and Pharmacokinetics (PK) of IDE892 as monotherapy and in combination with other agents including IDE397 in participants with methylthioadenosine phosphorylase (MTAP)-deleted advanced solid tumors within indications of interest.

Evaluation of Skin Tests in Biotherapy Allergies

Biotherapies are biological (extracted from an organism or living tissue) or biotechnological drugs used in the treatment of multiple conditions, such as autoimmune inflammatory diseases, cancers, and hematologic diseases. In recent years, these biotherapies have notably emerged in the treatment of cancers and hematologic disorders. As such, most patients with cancers or hematologic diseases will likely receive a biotherapy as part of their care pathway. These biotherapies are associated with various side effects, including hypersensitivity or allergic reactions, which are often poorly characterized in clinical trials. These reactions manifest as symptoms without specific dermatologic or allergologic semiology (such as itching, erythema, shortness of breath, sometimes digestive issues, or discomfort, and in some cases, an anaphylactic reaction). Unlike other treatments, such as antibiotics and neuromuscular blockers, there are currently no guidelines on the concentrations to use in skin tests for biotherapies. We propose conducting prospective clinical research to scientifically establish the concentrations to be used when investigating hypersensitivity to a biotherapy, in line with best practice recommendations for drug skin testing.

INTEGRATIVE "MULTI-OMICS" AND FUNCTIONAL PLATFORM FOR THE COMPLETE DIAGNOSTIC CHARACTERIZATION OF TUMORS: THE ITALIAN TUMOR CHEMOGENOMIC PROFILER (IT-TCP)

This is a multicenter, experimental preclinical study conducted on primary samples from patients diagnosed with hematological or solid neoplasms defined as high risk. The study will be prospective, based on the consecutive enrollment of eligible patients at each participating institution.

Induction Chemo+Immunotherapy in Resectable Epithelioid and Biphasic Pleural Mesothelioma (CHIMERA Study)

This is a prospective, open-label, multi-site Phase II trial of pembrolizumab in combination with pemetrexed and cisplatin or carboplatin as neo-adjuvant therapy followed by surgery and adjuvant pembrolizumab in patients affected by resectable stage I-IIIa chemonaïve epithelioid/biphasic pleural mesothelioma.

A Study of Oral 7HP349 (Alintegimod) in Combination With Ipilimumab Followed by Nivolumab Monotherapy

This study is an open-label Phase Ib (Part A) dose escalation followed by a blinded, randomized, multi cohort Phase 2a (Part B) comparison of combination vs. reference regimens. Currently study will only be enrolling the Phase 1b and the Phase 2a protocol requirements will be added to the study near completion of the Phase 1b

TTFields in General Routine Clinical Care in Patients With Pleural Mesothelioma Study

The purpose of this post-authorisation medical device study is to obtain real life data on the use of Tumor Treating Fields (TTFields) in patients with pleural mesothelioma in routine clinical care. Patients with pleural mesothelioma and clinical indication for TTFields treatment will be enrolled in the study after signing Informed consent to use their data and process it centrally for research purposes. The clinical indication for TTFields is one of the inclusion criteria and is defined prior to inclusion by the treating physician.

A Beta-only IL-2 ImmunoTherapY Study

This is a Phase 1/2, multi-center, open-label, dose-escalation and expansion study to evaluate safety and tolerability, PK, pharmacodynamic, and early signal of anti-tumor activity of MDNA11 alone or in combination with a checkpoint inhibitor in patients with advanced solid tumors.

The Diagnostic Accuracy and Clinical Value of FAPI PET in Pleural Mesothelioma

Seventy (N=70) patients with suspected pleural mesothelioma (PM) lesions referred to pleural biopsy will be recruited, and undergo an additional FAPI PET/CT at primary staging. The FAPI PET/CT results will be compared to conventional imaging (including FDG PET/CT). The diagnostic accuracy will be determined with histopathology as reference standard. For patients undergoing anticancer treatment (chemotherapy, immunotherapy, other treatment), an additional FAPI PET/CT and an additional FDG PET/CT will be conducted after the study subjects have completed 2-3 series of anticancer treatment. The feasabilitiy of FAPI PET/CT in response evaluation will be investigated. All study specific analyzes will be blinded and will not influence the patient management / treatment.

TRAcking Thoracic Cancer Evolution Through Therapy (Rx) EVO

TRACERx EVO is a programme of work using a prospective observational cohort study of participants with early- and late-stage non-small cell lung cancer (NSCLC), small cell lung cancer (SCLC) and pleural mesothelioma.

A Study of MT027 in Patients with Pleural Malignant Tumors

This is a phase I open label, single-arm, dose-escalation study to evaluate the feasibility, safety, tolerability, PK/PD, and to determine RP2D of MT027 via an locoregional delivery in subjects with pleural malignant tumors, who have previously received standard of care therapy.. Subjects meeting the study entry criteria including having tumor antigen B7H3 overexpression via immunohistochemistry (IHC ) will be enrolled and assigned to cohorts sequentially to receive study treatments, assessments, as well as post-treatment safety follow-ups in the study.

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.

Evaluation of Response by FLT PET in Mesothelioma

Pleural mesothelioma (MPM) is an aggressive tumor that affects the pleura and originates from mesothelial cells. If untreated, median survival is 4-12 months following diagnosis. Asbestos exposure is a risk factor associated with 80% of cases. After the 1980s, regulations controlling the use of asbestos ensured that cases were limited. Approximately 3,000 new cases are diagnosed each year in the United States. In general, a minority of patients are candidates for surgery at the time of presentation, so the mainstay of treatment is systemic chemotherapy. For patients who are surgical candidates, surgery is usually part of a multimodal treatment process that also includes chemotherapy and/or radiotherapy. Early and accurate diagnosis has a critical impact on the management of the disease due to limited response to multimodal treatments. Patients are often diagnosed at an advanced stage, leading to poor overall survival. Thorax and upper abdomen CT imaging are standard initial imaging modalities for clinical staging of MPM. Although CT identifies the general extent of the primary tumor, it may not definitively identify some areas of tumor invasion. There may be difficulties especially in the evaluation of chest wall and diaphragm invasion. 18F-FDG PET/CT has been widely used for cancer diagnosis, staging, treatment response and prognostic information for many years with high accuracy rates. 18F-FDG PET/CT provides valuable information on differentiating benign and malignant pleural abnormalities, evaluating the possibility of malignant involvement of mediastinal and hilar lymph nodes, and detecting distant metastases. 18F-FDG PET/CT identifies metastatic disease undetected on CT in approximately 10% of patients. At the same time, the degree of involvement (SUV) in FDG PET plays a role in predicting disease prognosis. 18F-FDG PET/CT can also be used to evaluate the treatment response in patients receiving chemotherapy, but due to chemotherapy-related inflammatory changes, it is necessary to wait at least 2 weeks to evaluate the treatment response. 18F-Fluorothymidine (FLT) is a thymidine kinase 1-specific substrate that is increased in proliferating cells and is associated with the Ki-67 index, a proliferation marker. It allows noninvasive evaluation of cell proliferation, especially the early evaluation of the response to cytotoxic chemotherapy. 18F-FLT PET/CT imaging has shown success in early evaluation of response to systemic endocrine, chemotherapy, radiotherapy and combined chemotherapy in multiple tumor types. The prognostic value of a decrease in 18F-FLT uptake after initiation of treatment has also been reported. In this study, it is aimed to evaluate the success of 18F-FLT PET/CT in the early evaluation of the response after the first cycle of chemotherapy in patients diagnosed with mesothelioma and receiving systemic chemotherapy. It is also aimed to evaluate the prognostic value of response evaluation made with this method. It is planned to prospectively include 25 patients with MPM who scheduled for chemotherapy in the study. Included patients will undergo 18F-FDG PET/CT before chemotherapy followed by 18F-FLT PET/CT imaging within two weeks. 18F-FLT PET/CT will be performed on the 4th day after the 1st cycle of chemotherapy. After chemotherapy is completed, treatment response will be evaluated with 18F-FDG PET/CT. Patients will then be followed by their clinicians for relapse and progressive disease. Thus, the success of early 18F-FLT PET/CT in predicting end of treatment response will be evaluated.

Study of Cadonilimab Combined With Bevacizumab and Standard Chemotherapy as First Line Therapy in Unresectable Pleural Mesothelioma

Cadonilimab, a tetravalent bispecific antibody targeting PD-1 and CTLA-4, is designed to retain the efficacy benefit of combination of PD-1 and CTLA-4 and improve on the safety profile of the combination therapy. The aim of this study is to evaluate the efficacy and safety of cadonilimab in combination with bevacizumab and standard chemotherapy as first Line therapy in unresectable pleural mesothelioma.