Phase 1 study of AB521 in renal cell carcinoma and other solid tumours
Research type
Research Study
Full title
A Phase 1, open-label, dose escalation and dose expansion study, to investigate the safety, tolerability, and pharmacokinetic profile of AB521 monotherapy and combination therapies in participants with clear cell renal cell carcinoma and other solid tumors
IRAS ID
1010822
Contact name
Manish Monga
Contact email
Sponsor organisation
Arcus Biosciences, Inc.
Clinicaltrials.gov Identifier
Research summary
Renal cell carcinoma (RCC) accounts for 90% of all kidney cancers, with clear cell renal cell carcinoma (ccRCC) making up 83% to 88% of RCC subtypes. Beyond the current standard of care for ccRCC, subsequent treatment options are limited. The purpose of the study is to test the safety and side effects of the study drug, AB521, when given alone or as a combination therapy with cabozantinib (an approved medication) to participants with clear cell renal carcinoma and other solid tumours. This study drug is investigational because it is not approved by the UK Medicines and Healthcare Products Regulatory Authority (MHRA) or any other agencies like the MHRA to treat this type of cancer.
There are two stages in this study, a dose escalation stage and a dose expansion stage.
The dose escalation stage will test different doses of the study drug to see which dose is safer for people. The first 3-6 people may get the lowest dose and subsequent doses may be either reduced or raised in the next 3-6 people, depending on the development of any side effects. Participants will be told what dose they are taking. If the study drug does not cause serious side effects then there may be up to 6 dose groups, with 15 to 62 people will taking part. The study doctor will monitor each group carefully.
The dose expansion stage will continue to determine the safety of the study drug on its own and in combination with cabozantinib. Participants will be told how much of the study drug (and cabozantininb if applicable) they will be taking. Doses identified from the first stage of the study with manageable side effects will be given up to approximately 240 people. This will help doctors better understand the side effects that may happen with this study drug.
Patients will be remain on the study until they experience serious side effects, their cancer gets worse, they withdraw their consent, the study doctor tells them to stop, or the Sponsor closes the study, whichever occurs first.REC name
South Central - Oxford A Research Ethics Committee
REC reference
24/SC/0361
Date of REC Opinion
9 Jan 2025
REC opinion
Further Information Favourable Opinion