Safety and Efficacy of IMCnyeso in Advanced NY-ESO-1 and/or LAGE-1A Positive Cancers

Official Title

A Phase I/II Study of IMCnyeso, HLA- A*0201-Restricted, NY-ESO-1- and LAGE-1A-specific Soluble T Cell Receptor and Anti-CD3 Bispecific Molecule, in HLA-A*0201 Positive Patients With Advanced NY-ESO-1 and/or LAGE - 1A Positive Cancer

Summary:

IMCnyeso is a new biological therapy designed for the treatment of cancers which express NY-ESO-1 and/or LAGE-1A. This is a first-in-human trial designed to evaluate the safety and efficacy of IMCnyeso in adult patients who have the appropriate HLA-A2 tissue marker and whose cancer is positive for NY-ESO-1 and/or LAGE-A1.

Trial Description

Primary Outcome:

• Phase I: Incidence of dose-limiting toxicities (DLT)
• Phase I: incidence and severity of adverse events (AE)
• Phase I: changes in laboratory parameters
• Phase I: changes in body temperature
• Phase I: changes in pulse
• Phase I: changes in respiratory rate
• Phase I: changes in blood pressure
• Phase I: changes in electrocardiogram parameters
• Phase I: dose interruptions, reductions, and discontinuations
• Phase II: Best overall response (BOR)

Secondary Outcome:

• Phase II: incidence and severity of adverse events (AE)
• Phase II: changes in laboratory parameters
• Phase II: changes in body temperature
• Phase II: changes in pulse
• Phase II: changes in respiratory rate
• Phase II: changes in blood pressure
• Phase II: changes in electrocardiogram parameters
• Phase II: dose interruptions, reductions, and discontinuations
• Phase I: Best overall response (BOR)
• Progression-free survival
• Duration of response
• Overall survival
• Pharmacokinetics Area under the plasma concentration-time curve (AUC)
• Pharmacokinetics The maximum observed plasma drug concentration after single dose administration (Cmax)
• Pharmacokinetics The time to reach maximum plasma concentration (Tmax)
• Pharmacokinetics The elimination half-life (t1/2)
• Immunogenicity the incidence of anti-IMCnyeso antibody formation Immunogenicity the incidence of anti-IMCnyeso antibody formation

This is a multi-centre, open label, dose finding Phase 1/2 study of single agent IMCnyeso administered in patients with NY-ESO-1 and/or LAGE-A1 positive tumours. The primary objective of the dose escalation phase (Arm 1) is to determine the maximum tolerated dose (MTD) and/or recommended Phase II dose (RP2D) of IMCnyeso in patients with advanced solid tumours. Preliminary efficacy will be evaluated in Arm 2.

View this trial on ClinicalTrials.gov