Clinical Trials

A Phase 1/2 Trial of TC-510 In Patients With Advanced Mesothelin-Expressing Cancer

Primary Outcome Measures Phase 1 – Establish the recommended Phase 2 dose (RP2D) according to dose-limiting toxicity (DLT) of defined adverse events. [ Time Frame: DLTs within 28 days post-treatment ] Phase 1 -The number and percent of patients in the DLT evaluable set who experienced DLTs from the first administration of study drug[…]

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Niraparib Efficacy in Patient With Unresectable Mesothelioma (NERO)

Primary Outcome Measures Progression-free survival [ Time Frame: From date of randomisation until the date of the first documented progression or date of death from any cause, whichever came first, assessed up to 18 months ] Progression-free survival is the determined by modified RECIST (pleural disease), RECIST 1.1 (for non-pleural disease), investigator reported progression[…]

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Intraperitoneal Paclitaxel for Patients With Primary Malignant Peritoneal Mesothelioma (INTERACT MESO)

Primary Outcome Measures The maximum tolerable dose (MTD) [ Time Frame: After two completed cycles of therapy (each cycle is 1 week) ] The primary endpoint of the study is to determine the maximum tolerable dose (MTD) of intraperitoneal (IP) paclitaxel monotherapy, for patients with malignant peritoneal mesothelioma (MPM) who are not eligible to[…]

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Immunological Variables Associated to ICI Toxicity in Cancer Patients

Primary Outcome Measures Modification(s) in the immune blood markers of treated subjects on treatment. [ Time Frame: Assessment: between week 4 and 6 after the first dose of the treatment ] Modification(s) in the immune blood markers including cytokines, immune cells and serum autoantibody level of treated subjects. Modification(s) in the immune blood markers[…]

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OT-101 in Combination With Pembrolizumab in Subjects With Malignant Pleural Mesothelioma Failing to Respond to Checkpoint Inhibition

Primary Outcome Measures Determination of ORR for the combination of OT-101 and pembrolizumab in subjects [ Time Frame: approximately 24 months ] modified RECIST (mRECIST; v1.1) Secondary Outcome Measures PFS, DOR and 6-month and 12-month Overall Survival (OS) will be estimated in all subjects in the ITT population. [ Time Frame: approximately 18 months ] Progression-free Survival (PFS),[…]

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Study of Safety, Pharmacokinetic and Efficacy of APG-5918 in Advanced Solid Tumors or Lymphomas

Primary Outcome Measures Dose-limiting Toxicity (DLT) [ Time Frame: 28 days ] DLTs will be assessed via CTCAE version 5.0 Inclusion Criteria Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 in dose escalation, 0 to 2 in dose expansion Has a life expectancy of >3 months Has a malignancy:[…]

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Feasibility Trial of a Personalised Nutrition and Activity Programme for People With Lung Cancer Over 65 Years (CanBenefitII)

Primary Outcome Measures Recruitment Rate [ Time Frame: 24 weeks ] The Recruitment Rate will be assessed by the number of eligible patients approached vs the number of eligible patients consent for the study, providing a number of non-participations. This will be gathered as an aspect of feasibility. Retention Rate [ Time Frame: 24 weeks ] Retention rate[…]

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Phase I Evaluation of Immunotoxin LMB-100 Administered by Normothermic, Intrapleural Perfusion Following Cytoreductive Surgery in Participants With Pleural Mesotheliomas, or Pleural Effusions From Cancers Expressing Mesothelin

Primary Outcome Measures Identify maximum tolerated dose (MTD) and evaluate the toxicities of LMB-100 administered by 90-minute normothermic, intrapleural perfusion in participants with mesothelin-positive MPM, or MPE from cancers that express mesothelin [ Time Frame: 21 days ] List of adverse event frequency, type, and grade Safety data based on toxicity grades and types[…]

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— SMARTEST Trial—

Primary Outcome Measures CD8 TILs density / gross tumor volume (GTV) [ Time Frame: Up to five years ] The primary objective of the study is to demonstrate that low dose cyclophosphamide in combination with sub-ablative radiation can enhance the anti-tumoral immune response compared to sub-ablative radiation alone Secondary Outcome Measures Survival [ Time Frame: Up to[…]

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A Phase II Clinical Trial to Evaluate Safety and Efficacy of XmAb20717 in Advanced Rare Cancers

Primary Objective Efficacy of XmAb20717 as defined by objective response (defined as a complete response [CR] or partial response [PR] on two consecutive occasions ≥4 weeks apart) as determined by an independent radiologist according to RECIST v1.1 (modified RECIST for pleural mesothelioma) Secondary Objective Objective response as determined by an[…]

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