Loading...
Incidence of dose limiting toxicities for patients in the dose escalation phase
Safety and tolerability will be evaluated by incidence of DLTs
Safety and tolerability will be evaluated by laboratory measurements
Safety and tolerability will be evaluated by dose interruption, modification, and discontinuation due to adverse events (AEs) according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE)
Maximum tolerated dose will be determined by the sponsor based on the Safety Review Committee's recommendation considering the totality of the available clinical safety, clinical efficacy, pharmacokinetics (PK), and pharmacodynamic data
The RDE will be determined by the sponsor based on the Safety Review Committee's recommendation considering the totality of the available clinical safety, clinical efficacy, pharmacokinetics (PK), and pharmacodynamic data
Best overall response of either complete response (CR) or partial response (PR), as assessed by the investigator per RECIST v1.1
Pharmacokinetics will be calculated including the maximum observed plasma concentration
Pharmacokinetics will be calculated including the area under the plasma concentration versus time curve (AUC)
Pharmacokinetic parameters will be calculated using standard non-compartmental techniques
The pharmacodynamic effect of PRT7732 demonstrating target engagement by assessment of SMARCA2 protein in peripheral blood mononuclear cells and tumor tissue as assessed by reduction in protein levels of SMARCA2 in peripheral blood mononuclear cells and/or tumor tissue