A First-in-human Study to Evaluate the Safety and Tolerability of AZD8853 in Participants with Selec
Research type
Research Study
Full title
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
IRAS ID
1005813
Contact name
Eleonor Bystedt
Contact email
Sponsor organisation
AstraZeneca
Eudract number
2021-005438-41
Clinicaltrials.gov Identifier
Research summary
The investigational study medication AZD8853 is a type of cancer treatment that works with the immune system to find and attack cancer. The aim of the study is to see how safe and tolerable AZD8853 is in treating advanced/metastatic solid tumours, and whether it can prevent the cancer from worsening or spreading to new places.
The study will include about 165 participants with advanced/metastatic solid tumours across several countries globally.
AZD8853 will be given in 21-day (3 weeks) treatment cycles on the first day of each cycle, through a vein (intravenously), and infusion will take around 1 hour.
The participants will be in the study for about 6 months, but this can be shorter or longer depending on how well their cancer responds to the study treatment. The study may have several sub-studies, depending on the data.
The current sub-study, Substudy 1, will be include the following parts:
Part A: Participants with non-small-cell lung cancer (NSCLC), microsatellite stable-colorectal cancer (MSS-CRC), or urothelial carcinoma (UC) will receive AZD8853 which will be tested as a single treatment (not in combination with other medications) at different dose levels find the highest safe dose.
Part B: Participants with NSCLC or MSS-CRC will receive AZD8853 which will be tested as a single treatment at the highest safe dose or at a lower safe dose to further look at safety and how the drug works with participants’ cancer.
Part C: Participants with NSCLC or MSS-CRC will receive AZD8853 which will be tested as a single treatment at dose levels found to be safe in Part B to look how well participants’ cancer responds to study treatment.
The Sponsor of the study is AstraZeneca AB.REC name
North East - York Research Ethics Committee
REC reference
22/NE/0179
Date of REC Opinion
25 Nov 2022
REC opinion
Further Information Favourable Opinion