Clinical Trials
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 will be examined via the…
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 of toxicity will be reported…
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 five years ] Demonstrate the safety…
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 independent radiologist according to immune-modified…
Primary Outcome Measures Incidence of Adverse Events (AEs) [ Time Frame: Up to 6 Months ] Time to onset of serious adverse events (SAEs) [ Time Frame: Up to 6 Months ] Time to onset of AEs [ Time Frame: Up to 6 Months ] Time to resolution of AEs [ Time Frame: Up to 6 Months ] Time to resolution of SAEs [ Time Frame: Up to 6 Months ] Incidence of physician seriousness…
Primary Outcome Measures Progression Free Survival assessed locally [ Time Frame: time from first dose of combination Nivolumab-Ipilimumab to first documentation of disease progression or to death from any cause evaluated through the total duration of the study (up to 48 months) ] Progression free survival as assessed by the investigator, defined as the time from first dose of…
Primary Outcome Measures Number of participant who are alive and have completed (neo)adjuvant DCT (5 administrations) and surgery at week 15 (+4 weeks) without extended treatment-related delay, persisting grade 3-4 treatment side-effects or evidence of progression [Feasibility] [ Time Frame: 2 years ] To determine the feasibility of DCT with Mesopher performed before and after eP/D in patients with…
Primary Outcome Measures Dose-limiting Toxicity [ Time Frame: First 21 days of treatment. ] The incidence of DLTs during the DLT assessment period. Frequency and Severity of Adverse Events (AE) [ Time Frame: Screening to 90 days from last dose. ] The incidences and percentages of patients experiencing AEs summarized by NCI CTCAE version 5.0 grade and by causality. Dose Finding [ Time Frame: Screening to…
Primary Outcome Measures Phase 1: [ Time Frame: 28 days ] To determine the MTD and dosing schedule of TNG908 Phase 2: [ Time Frame: 16 weeks ] To assess anti-neoplastic activity of TNG908 in patients with MTAP-deleted advanced solid tumors by RECIST v1.1 Secondary outcome Measures Phase 1: [ Time Frame: 16 weeks ] To assess preliminary evidence of anti-neoplastic activity of TNG908 in patients with…
Primary Outcome Measures Safety and tolerability of IK-930 [ Time Frame: Through study completion, an average of 36 months ] The frequency and severity, incidence of treatment-emergent and treatment-related adverse events using NCI-CTCAE v5.0 Occurrence of Dose Limiting Toxicity during first treatment cycle [ Time Frame: Approximately 1 year ] RP2D and/or MTD of IK-930 [ Time Frame: Approximately 1 year ] Define the recommended phase 2…
