NCT04995523

A Study of AZD2936 Anti-TIGIT/Anti-PD-1 Bispecific Antibody in Participants With Advanced or Metastatic NSCLC

Phase I/II, Open-label, Dose Escalation and Dose Expansion Study to Evaluate Safety, Pharmacokinetics, Pharmacodynamics and Efficacy of AZD2936 Anti-TIGIT/Anti-PD-1 Bispecific Antibody in Participants With Advanced or Metastatic NSCLC

• Status: Active Not Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 212 (actual)
• Sponsor: AstraZeneca · Industry
• Sex: All
• Age: 18 Years – 130 Years
• Healthy volunteers: Not accepted

Summary

This is a Phase I/II study designed to evaluate if experimental anti-TIGIT/anti-PD-1 bispecific antibody rilvegostomig (AZD2936) is safe, tolerable and efficacious in participants with Advanced or Metastatic Non-small Cell Lung Cancer.

Detailed description

This is a first-time-in-human (FTIH), open-label, multicenter, multi-part, dose-escalation and dose-expansion study to evaluate the safety, pharmacokinetics (PK), pharmacodynamics, and efficacy of rilvegostomig (AZD2936) in adult participants with stage III unresectable or stage IV NSCLC. The study includes 4 parts: Part A (dose escalation) and Parts B-E (dose expansion).

Conditions

• Non-Small-Cell Lung Carcinoma

Interventions

Type	Name	Description
DRUG	AZD2936	Anti-TIGIT/Anti-PD-1 Bispecific Antibody

Timeline

• Start date: 2021-09-14
• Primary completion: 2026-08-28
• Completion: 2028-06-01
• First posted: 2021-08-09
• Last updated: 2026-03-24

Locations

40 sites across 16 countries: United States, Australia, Belgium, Brazil, China, Denmark, France, Georgia, Japan, Malaysia, Moldova, Netherlands, South Korea, Spain, Taiwan, Thailand

Regulatory

• FDA-regulated drug study