Primary Outcome Measures Occurrence of Dose Limiting Toxicity [ Time Frame: over the first 21 days of dosing ] Incidence of Adverse and Serious Adverse Events Occurrence of General Toxicity [ Time Frame: through study completion, an average of 30 months ] Incidence of Adverse and Serious Adverse Events, Discontinuations due to Adverse Events and general safety Evaluations[…]
Primary Outcome Measures safety of PB103 [ Time Frame: one year ] assessment of adverse events Secondary Outcome Measures efficacy of PB103 [ Time Frame: one year ] assessment of Progression Free Survival, PFS Inclusion Criteria Recipient: Recipients (Subjects) are between 20-70 years of age. Related donor: 6/6 matched at HLA-A, -B and -DRb1 or haploidentical donor ≥[…]
This study will test the safety of MSLN-targeted CAR-T cells at different doses to find the safest dose to give to people with MPM. The researchers want to see what effects, if any, the study treatment has on people with this type of cancer. This study is the first time that an MSLN-targeted CAR-T cell treatment with an anti-PD1 component is being given to people.
A Two-part Study to Characterize Drug-Drug Interaction Effects on Steady-State Pharmacokinetics of Oral Tazemetostat
This is a phase I, multi-center, open-label, multi-dose, two-part PK and safety study to characterize the DDI potential of oral Tazemetostat.
Primary Outcome Measures The probability of rejecting the investigational treatment is at least 81%, if the DLT rate is greater than 33% and the probability of accepting the treatment is at least 71% if the DLT rate is less than a safe level of 17%. [ Time Frame: up to 27 days ] Safety[…]
In this study, researchers will give olaparib (a drug) to mesothelioma patients who have specific changes in their DNA (known as gene mutations). Researchers will give this drug to each patient on the study to find out if it will help the patient’s tumor shrink or stop growing.
Primary Outcome Measures Dose-limiting toxicity （DLT） [ Time Frame: After 28 days of single infusion ] Safety Secondary Outcome Measures Maximum tolerated dose (MTD) [ Time Frame: After 28 days of single infusion ] Tolerability Objective response rate (ORR) [ Time Frame: Month 12 ] Clinical response will be assessed by RECIST 1.1. Progression-free survival (PFS) [ Time Frame: Month 12 ] PFS of patients receiving[…]
Primary Outcome Measures Feasibility and acceptability as measured by participant rates of enrollment [ Time Frame: 6 months ] Feasibility assessed by % of patients that agree to participate. Project feasible if >30% of the patients approached agree to participate Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE Version 5.0 [ Time Frame: Time[…]
Primary Outcome Measures Primary endpoint for cohort 1: Objective response rate (ORR) according to RECIST 1.1 [ Time Frame: At the date of tumor assessment according to RECIST 1.1, assessed up to 2 years after registration ] ORR according to RECIST 1.1 is defined as the proportion of patients, whose best overall response is[…]
Efficacy of a Maintenance Treatment With TALAzoparib Following First Line Platinum-based Chemotherapy in Malignant MESOthelioma (TALAMESO)
Primary Outcome Measures Non-progression proportion [ Time Frame: 6 month after starting talazoparib ] The non-progression proportion is defined as the proportion of patients free of progression 6 months after talazoparib start. Disease progression will be based on (i) tumor assessment made by the investigators according to the RECIST 1.1 criteria and/or, ii) non-equivocal[…]