NCT04931654

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

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 Tumors.

• Status: Active Not Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 136 (actual)
• Sponsor: AstraZeneca · Industry
• Sex: All
• Age: 18 Years – 130 Years
• Healthy volunteers: Not accepted

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 tumors.

Detailed description

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

Conditions

• Carcinoma, Non-Small-Cell Lung
• Gastric Cancer
• Gastroesophageal Junction Cancer

Interventions

Type	Name	Description
DRUG	AZD7789	anti-PD-1 and anti-TIM-3 bispecific antibody

Timeline

• Start date: 2021-09-28
• Primary completion: 2024-12-04
• Completion: 2026-08-12
• First posted: 2021-06-18
• Last updated: 2025-10-09

Locations

21 sites across 10 countries: United States, Canada, China, France, Georgia, Japan, Moldova, Netherlands, Spain, Turkey (Türkiye)

Regulatory

• FDA-regulated drug study