Primary Outcome Measures Number of participants with adverse events (AEs) [ Time Frame: Through 30 days after the last study treatment; approximately 7 months ] Any untoward medical occurrence in a clinical investigational participant administered a medicinal product and which does not necessarily have a causal relationship with this treatment. Number of participants with[…]
Clinical Trials
SynKIR-110 for Mesothelin Expressing Ovarian Cancer, Cholangiocarcinoma or Mesothelioma
Primary Outcome Measures Safety and feasibility of SynKIR-110 [ Time Frame: Date of enrollment through date of last patient visit, up to 36 months. ] • The incidence, frequency, and severity of TEAEs, incidence of AEs related to native mesothelin-expressing tissues, • Incidence of CRS and/or neurologic toxicity Secondary Outcome Measures Define the MTD[…]
A Phase 1 Study of PRT3645 in Participants With Select Advanced or Metastatic Solid Tumors
Primary Outcome Measures Dose limiting toxicity (DLT) of PRT3645 [ Time Frame: Baseline through Day 28 ] Dose limiting toxicity will be evaluated over the 28-day observation period Safety and tolerability of PRT3645: AEs, CTCAE Assessments [ Time Frame: Baseline through approximately 2 years ] Safety and tolerability will be evaluated by incidence of DLTs, laboratory measurements, severity[…]
TTFields in General Routine Clinical Care in Patients With Pleural Mesothelioma Study (TIGER Meso)
Primary Outcome Measures Time from diagnosis of pleural mesothelioma to death of any cause as median overall survival time. [ Time Frame: 54 Months ] Secondary Outcome Measures Number of TTFields treatment-related SAEs, as assessed by the CEC, within total observation period, standardized to average annual incidences. [ Time Frame: 3 years + 18 months follow up ][…]
AMT-151 in Patients With Selected Advanced Solid Tumours
Primary Outcome Measures Recommended Phase 2 Dose (RP2D) [ Time Frame: Up to 24 months ] The RP2D will be determined using dose limiting toxicities (DLTs) and all other available study data Maximum Tolerated Dose (MTD) [ Time Frame: Up to 24 months ] The MTD will be determined using DLTs Incidence of Adverse Events [ Time Frame: Up to 24[…]
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[…]
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[…]
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[…]
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[…]
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[…]
