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

Active:	No
Cancer Type:	Colon/Rectal Cancer Lung Cancer	NCT ID:	NCT05397171
Trial Phases:	Phase I Phase II	Protocol IDs:	D9450C00001 (primary) NCI-2022-04992 2021-005438-41
Eligibility:	18 - 130 Years, Male and Female	Study Type:	Treatment
Study Sponsor:	AstraZeneca Pharmaceuticals LP
NCI Full Details:	http://clinicaltrials.gov/show/NCT05397171

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.

Objectives

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.

Treatment Sites in Georgia

Winship Cancer Institute of Emory University
1365 Clifton Road NE
Building C
Atlanta, GA 30322
404-778-5180
winshipcancer.emory.edu

**Clinical trials are research studies that involve people. These studies test new ways to prevent, detect, diagnose, or treat diseases. People who take part in cancer clinical trials have an opportunity to contribute to scientists’ knowledge about cancer and to help in the development of improved cancer treatments. They also receive state-of-the-art care from cancer experts... Click here to learn more about clinical trials.