AZD5863 for Advanced Solid Cancers
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores a new treatment called AZD5863 to determine its safety and effectiveness for individuals with advanced solid tumors, specifically in the stomach, esophagus, or pancreas. The treatment uses a special antibody to help the immune system target cancer cells more effectively. Participants will receive the treatment either through injection under the skin or directly into a vein. This trial may suit those diagnosed with certain advanced cancers who have already tried at least one other treatment. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new therapy.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but it excludes participants on anticoagulation therapy and those requiring chronic immunosuppressive therapy. It's best to discuss your specific medications with the trial team.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research shows that AZD5863, a new treatment for advanced solid cancers, has potential for safety. AZD5863 is a bispecific antibody, targeting both Claudin 18.2 on tumor cells and CD3 on T cells (a type of immune cell). This dual-targeting approach aims to help the immune system fight cancer.
Studies have noted that AZD5863 binds less tightly to CD3. This might mean fewer side effects, as it could reduce the risk of the immune system overreacting, potentially improving the treatment's safety.
Both subcutaneous (under-the-skin) and intravenous (into-the-vein) forms of AZD5863 are being tested. Since this study is in its early stages, it focuses on ensuring the treatment's safety and assessing patient tolerance. While earlier studies suggest a promising safety profile, more research is needed to confirm this.12345Why do researchers think this study treatment might be promising?
Unlike the standard treatments for advanced solid cancers, which typically include chemotherapy and targeted therapies, AZD5863 introduces a unique approach by offering two distinct delivery methods: subcutaneous (SC) and intravenous (IV) administration. Researchers are excited about AZD5863 because it targets cancer cells with precision, potentially leading to fewer side effects compared to traditional treatments. Additionally, the flexible delivery options might provide patients with more comfort and convenience, making it an attractive option for diverse patient needs. This innovative approach has the potential to improve treatment efficacy and patient experience in managing advanced solid cancers.
What evidence suggests that AZD5863 might be an effective treatment for advanced solid cancers?
Research has shown that AZD5863, a special type of antibody, may help fight advanced solid tumors. It targets two proteins, Claudin 18.2 and CD3, to enable the immune system to attack cancer cells. Tests in labs and animals demonstrated that AZD5863 effectively kills cancer cells in mice and lab-grown cells. These early results are promising and suggest that AZD5863 might benefit people with advanced cancers. In this trial, participants will receive AZD5863 either as a subcutaneous (SC) or intravenous (IV) monotherapy. While more research with humans is needed, these findings offer a hopeful sign of its potential effectiveness.23467
Are You a Good Fit for This Trial?
Adults over 18 with advanced solid tumors like pancreatic, esophageal, or stomach cancer can join this trial if they've had at least one prior treatment for advanced cancer. They need a life expectancy of 12 weeks or more, measurable tumor lesions, and positive CLDN18.2 expression in their tumor cells. Good physical health is required (ECOG PS: 0-1), as well as proper organ and bone marrow function.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Dose Escalation
Participants receive AZD5863 monotherapy in a dose-escalation format to determine the maximum tolerated dose
Dose Expansion
Participants receive AZD5863 monotherapy at the determined dose to further evaluate safety and efficacy
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- AZD5863
Find a Clinic Near You
Who Is Running the Clinical Trial?
AstraZeneca
Lead Sponsor
Sir Pascal Soriot
AstraZeneca
Chief Executive Officer since 2012
Veterinary Medicine from École nationale vétérinaire d'Alfort, MBA from HEC Paris
Dr. Cristian Massacesi
AstraZeneca
Chief Medical Officer since 2021
MD from Marche Polytechnic University, Oncology training at Royal Marsden Hospital, Kaplan Comprehensive Cancer Center, and European Institute of Oncology
Pascal Soriot
AstraZeneca
Chief Executive Officer since 2012
Veterinary Medicine from École nationale vétérinaire d'Alfort, MBA from HEC Paris
Cristian Massacesi
AstraZeneca
Chief Medical Officer since 2021
MD from Marche Polytechnic University, Medical Oncology training at Royal Marsden Hospital, Kaplan Comprehensive Cancer Center, and European Institute of Oncology