NCT05397171

A First-in-human Study to Evaluate the Safety and Tolerability of AZD8853 in Participants With Selected Advanced/Metastatic Solid Tumours

A Phase I/IIa First-in-human, Open-label Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy of AZD8853 in Participants With Selected Advanced/Metastatic Solid Tumours

• Status: Terminated
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 17 (actual)
• Sponsor: AstraZeneca · Industry
• Sex: All
• Age: 18 Years – 130 Years
• Healthy volunteers: Not accepted

Summary

A Phase I/IIa First-in-human, Open-label Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy of AZD8853 in Participants with Selected Advanced/Metastatic Solid Tumours.

Detailed description

This study is evaluating the safety, pharmacokinetics, pharmacodynamics, and preliminary efficacy of AZD8853 in participants with advanced, unresectable or metastatic Non-Small Cell Lung Cancer (NSCLC), Microsatellite Stable Colorectal Cancer (MSS-CRC), Urothelial Carcinoma (UC). This is a modular study, that includes a master protocol and Substudies. Substudy 1 will be conducted in 3 parts - Part A: Dose escalation, Part B: Safety expansion and exploratory CD8+ T cell radiopharmaceutical tracer with PET imaging, and Part C: Efficacy expansion.

Conditions

• Urinary Bladder Neoplasms
• Colorectal Cancer
• Carcinoma, Non-Small-Cell Lung

Interventions

Type	Name	Description
DRUG	AZD8853	Monotherapy given until progressive disease or upon meeting other discontinuation criteria.
DRUG	Zirconium-89 crefmirlimab berdoxam	CD8+ T cell tracer for positron emission tomography (PET) at two time points in addition to monotherapy AZD8853

Timeline

• Start date: 2022-06-07
• Primary completion: 2023-06-06
• Completion: 2023-06-06
• First posted: 2022-05-31
• Last updated: 2024-10-01
• Results posted: 2024-10-01

Locations

6 sites across 2 countries: United States, Canada

Regulatory

• FDA-regulated drug study