A Study to Assess the Safety and Efficacy of AZD7789 in Participants With Advanced or Metastatic Solid Cancer

Official Title

A Phase I/IIa Open-label Dose Escalation and Expansion Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Efficacy of AZD7789, an Anti-PD-1 and Anti-TIM-3 Bispecific Antibody, in Participants With Advanced or Metastatic Solid Tumours

Summary:

This is a Phase I/IIa study designed to evaluate if experimental anti-PD-1 and anti-TIM-3 bispecific antibody, AZD7789 is safe, tolerable and efficacious in participants with advanced solid tumours.

Trial Description

Primary Outcome:

• Number of participants with adverse events (AE), serious adverse events (SAE) and immune-mediated AEs (imAE)
• Number of participants with dose-limiting toxicity (DLT), as defined in the protoocol
• Preliminary anti-tumour activity of AZD7789

Secondary Outcome:

• Objective response rate
• Disease control rate
• Duration of response
• Progression-free survival
• Overall survival
• Pharmacokinetics of AZD7789: Maximum plasma concentration of the study drug (Cmax)
• Immunogenicity of AZD7789
• Pharmacokinetics of AZD7789: Area Under the concentration-time curve (AUC)
• Pharmacokinetics of AZD7789: Clearance
• Pharmacokinetics of AZD7789: Terminal elimination half-life (t 1/2)

This first time in patients, open-label, multi-centre study will have AZD7789 administered intravenously (IV) to participants with advanced solid tumours. This study will have 2 parts: Part A which will have dose escalation cohorts and Part B which will have the dose expansion cohorts.

View this trial on ClinicalTrials.gov