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Monoclonal Antibodies

AZD5863 for Advanced Solid Cancers

Phase 1 & 2

Recruiting

Research Sponsored by AstraZeneca

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from the start of study treatment/date of randomization to death (to be followed-up for approx. 2 years)

Awards & highlights

Study Summary

This trial tests if a new drug can safely and effectively treat advanced solid tumors. #CancerResearch

Who is the study for?

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.Check my eligibility

What is being tested?

The study tests AZD5863, an experimental drug that targets specific proteins on T cells and cancer cells to fight the tumor. It's given to see if it's safe and effective against certain types of solid tumors that have spread or cannot be removed by surgery.See study design

What are the potential side effects?

Potential side effects may include reactions related to the immune system such as cytokine release syndrome (CRS) which can cause fever and fatigue; neurotoxicity; inflammation-related symptoms affecting different organs; infection risks due to immune response changes; plus common drug-related adverse events.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from the start of study treatment/date of randomization to death (to be followed-up for approx. 2 years)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from the start of study treatment/date of randomization to death (to be followed-up for approx. 2 years)

This trial's timeline: 3 weeks for screening, Varies for treatment, and from the start of study treatment/date of randomization to death (to be followed-up for approx. 2 years) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

The number of patients with adverse events

The number of patients with adverse events of special interest

The number of patients with dose-limiting toxicity (DLT), as defined in the protocol.

+1 more

Secondary outcome measures

Disease Control Rate (DCR)

Duration of response (DoR)

Immunogenicity of AZD5863

+8 more

Trial Design

2Treatment groups

Experimental Treatment

Group I: Module 2: AZD5863 Monotherapy Subcutaneous (SC)Experimental Treatment1 Intervention

Module 2: AZD5863 Subcutaneous (SC) Monotherapy

Group II: Module 1: AZD5863 Monotherapy Intravenous (IV)Experimental Treatment1 Intervention

Module 1: AZD5863 Intravenous (IV) Monotherapy

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

AstraZenecaLead Sponsor

4,272 Previous Clinical Trials

288,612,475 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the research still recruiting volunteers?

"Affirmative. Clinicaltrials.gov records show that this research trial, which was initially posted on July 11th 2023, is still looking for participants to join. A total of 200 patients are needed from 19 distinct sites."

Answered by AI

How much patient participation is required for this experiment?

"Correct. Clinicaltrials.gov clearly states that this research, which was posted on July 11th 2023, is currently looking for participants. 200 people need to be recruited from 19 sites nationwide."

Answered by AI

How extensive is the trial’s presence in terms of clinical research centers?

"This study is presently enrolling patients and has 19 sites located across the globe, including cities such as Rochester, Beijing, and many others. If you choose to join this trial it may be beneficial for you to select a site nearby in order to reduce any travelling costs associated with participation."

Answered by AI

What goals is the clinical trial hoping to accomplish?

"The primary goal of this clinical trial is assessing the occurrence of adverse events, with secondary objectives such as Disease Control Rate (DCR), Duration of Response (DoR) and Progression Free Survival (PFS). This experiment will take place over a period spanning from first dose up to 90 days post last dose."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Study of AZD5863 in Adult Participants With Advanced or Metastatic Solid Tumors

2023. "Study of AZD5863 in Adult Participants With Advanced or Metastatic Solid Tumors". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06005493.