Study of AZD5863 in Adult Participants With Advanced or Metastatic Solid Tumors
Condition(s) studied
Investigational drug(s) / intervention(s)
AZD5863: T cell-engaging bi-specific antibody that targets CLDN18.2 (Claudin18.2) on tumor cells and CD3 on T cells
AZD2936: Rilvegostomig is a bi-specific antibody targeting the immunosuppressive PD-1 and TIGIT pathways.
Study summary
This research is designed to determine if experimental treatment with AZD5863, a T cell-engaging bispecific antibody that targets Claudin 18.2 (CLDN18.2) and CD3, is safe, tolerable and has anti-cancer activity in patients with advanced solid tumors.
Eligibility
Primary outcome measure(s)
- The number of patients with adverse events — From first dose of study drug up to 90 days post last dose and prior to start of subsequent anticancer therapy
Number of patients with adverse events by system organ class and preferred term - The number of patients with adverse events of special interest — From first dose of study drug up to 90 days post last dose and prior to start of subsequent anticancer therapy
Number of patients with adverse events of special interest by system organ class and preferred term - The number of patients with dose-limiting toxicity (DLT), as defined in the protocol. — From first dose of study drug until the end of Cycle 1
A DLT is a toxicity as defined in the protocol that occurs from the first dose of study drug up to and including the planned end of Cycle 1 (the DLT assessment period) that is assessed as unrelated to the disease or disease-related processes under investigation. - The number of patients with serious adverse events — From first dose of study drug up to 90 days post last dose and prior to start of subsequent anticancer therapy
Number of patients with serious adverse events by system organ class and preferred term - Objective Response Rate (ORR) — From first dose of study drug to progressive disease or death in the absence of disease progression (approx. 2 years)
The percentage of patients with a confirmed investigator assessed complete or partial response according to response criteria in solid tumours (RECIST 1.1). Dose expansion only.
Trial sites (25)
| Facility | City | Region | Status |
|---|---|---|---|
| Research Site | Jacksonville | Florida | Recruiting |
| Research Site | Rochester | Minnesota | Recruiting |
| Research Site | New York | New York | Withdrawn |
| Research Site | Beijing | China | Recruiting |
| Research Site | Beijing | China | Recruiting |
| Research Site | Shandong | China | Recruiting |
| Research Site | Toulouse | France | Recruiting |
| Research Site | Villejuif | France | Recruiting |
| Research Site | Chūōku | Japan | Recruiting |
| Research Site | Kashiwa | Japan | Recruiting |
| Research Site | Kōtoku | Japan | Recruiting |
| Research Site | Amsterdam | Netherlands | Recruiting |
| Research Site | Groningen | Netherlands | Recruiting |
| Research Site | Rotterdam | Netherlands | Recruiting |
| Research Site | Seoul | South Korea | Recruiting |
| Research Site | Seoul | South Korea | Recruiting |
| Research Site | Seoul | South Korea | Recruiting |
| Research Site | Seoul | South Korea | Recruiting |
| Research Site | Kaohsiung City | Taiwan | Recruiting |
| Research Site | Tainan | Taiwan | Recruiting |
| Research Site | Taoyuan | Taiwan | Recruiting |
| Research Site | Dundee | United Kingdom | Recruiting |
| Research Site | London | United Kingdom | Recruiting |
| Research Site | Metropolitan Borough of Wirral | United Kingdom | Recruiting |
| Research Site | Oxford | United Kingdom | Recruiting |
More AstraZeneca trials in the Netherlands
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT06005493 on ClinicalTrials.gov ↗ ← All trials in the Netherlands