Recruiting

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.

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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.

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NM32-2668 in Adult Patients With Selected Advanced Solid Tumors

This is a first-in-human, open-label, multi-center, Phase 1, dose-escalation study with expansion cohorts to evaluate NM32-2668 for safety and immunogenicity, to determine the maximal tolerated dose and recommended Phase 2 dose, define the pharmacokinetics, to explore the pharmacodynamics, and to obtain preliminary evidence of the clinical activity in adult patients with selected advanced solid tumors.

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Treatment Pleural Carcinosis of Pressurized IntraThoracic Hyperthermic Aerosol Cisplatin Administration (PITHAC)

Within the context of pleural carcinosis, the present study is a dose escalation with determination of the maximum tolerated doses (MTD) of pressurized cisplatin administration associated to moderate hyperthermia in the pleura. This will be followed by an expansion phase at the recommended dose (RD).

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A Safety and Efficacy Study Evaluating CTX131 in Adult Subjects With Relapsed or Refractory Solid Tumors

Primary Outcome Measures Phase 1 (Dose Escalation): Incidence of adverse events [ Time Frame: From CTX131 infusion up to 28 days post-infusion ] Defined as dose-limiting toxicities Phase 2 (Cohort Expansion): Objective response rate (ORR) [ Time Frame: From CTX131 infusion up to 60 months post-infusion ] ORR based on Independent Review Committee (IRC) assessment, defined as the[…]

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First in Human Phase 1 Study of AG01 Anti-Progranulin/GP88 Antibody in Advanced Solid Tumor Malignancies

Primary Outcome Measures Maximum Tolerated Dose (MTD) and/or Maximum Administered Dose (MAD) [ Time Frame: 28 days during 1st cycle ] Determine the MTD and/or MAD of anti GP88 monoclonal antibody (AG-01) in subjects with advanced/refractory solid tumor malignancies for which no effective therapies exist. Antitumor Activity of AG-01 by Overall Response Rate (ORR)[…]

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Oral AMXT 1501 Dicaprate in Combination With IV DFMO

Primary Outcome Measures Determine DLTs and RP2Ds in AMXT 1501 in combination with IV DFMO [ Time Frame: 1 year ] Indicate Number of patients with DLTs in AMXT1501 in combination with IV DFMO in patients with advanced cancer to determine the RP2D within the duration of the dose escalation period of the study[…]

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Effect of HITHOC After Pleurectomy Decortication for Treatment of Malignant Pleural Mesothelioma

Primary Outcome Measures disease free survival or time to recurrence [ Time Frame: Through out the whole study with maximum of 2 years ] time from clearance of disease till onset of recurrence of same disease overall survival [ Time Frame: till mortality of the case or 2 years maximum ] survival of the cases till mortality Secondary[…]

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