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AZD8853 for Bladder Cancer

Phase 1 & 2

Waitlist Available

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 first documented response to disease progression or other end of study criteria are met (approximately 1 year)

Awards & highlights

Study Summary

This trial is testing a new drug, AZD8853, to see if it is safe and effective in treating advanced solid tumors.

Eligible Conditions

Bladder Cancer
Colorectal Cancer
Non-Small Cell Lung Cancer

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from first documented response to disease progression or other end of study criteria are met (approximately 1 year)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from first documented response to disease progression or other end of study criteria are met (approximately 1 year)

This trial's timeline: 3 weeks for screening, Varies for treatment, and from first documented response to disease progression or other end of study criteria are met (approximately 1 year) for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

All Substudies-Dose Escalation Parts Only: Number of Dose Limiting Toxicities (DLTs)

All Substudies: Incidence of AEs leading to discontinuation of AZD8853

All Substudies: Number of participants with adverse events (AEs)

+1 more

Secondary outcome measures

All Substudies: Area Under the Curve (AUC) of AZD8853

All Substudies: Change in ctDNA from baseline through post-treatment

All Substudies: Disease control rate (DCR) per RECIST 1.1

+9 more

Trial Design

2Treatment groups

Experimental Treatment

Group I: Substudy 1 - Parts B1 and B2 with CD8+ PETExperimental Treatment1 Intervention

Sub-set of participants from Parts B1 and B2 will also receive investigational CD8+ T cell targeted radioactive tracer, Zirconium-89 crefmirlimab berdoxam with PET scans

Group II: Substudy 1 - Parts A, B, and CExperimental Treatment1 Intervention

Part A: AZD8853 monotherapy dose escalation Part B1 and Part B2: AZD8853 monotherapy safety expansion at dose levels and indications determined to be safe in Part A Part C1 and Part C2: AZD8853 monotherapy safety and preliminary efficacy expansion at dose levels and indications determined to be safe in Parts A and B

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

AstraZenecaLead Sponsor

4,259 Previous Clinical Trials

288,593,886 Total Patients Enrolled

ImaginAb, Inc.Industry Sponsor

12 Previous Clinical Trials

284 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 this research trial open to participants aged 45 and older?

"The criteria for enrollment in this trial state that the minimum age is 18 and the maximum age is 130."

Answered by AI

How many subjects are participating in this investigation?

"Yes, this trial is still searching for participants. Clinicaltrials.gov has the most up-to-date information regarding its posting on 6/7/2022 and last update on 11/10/2022. A total of 165 individuals are needed from 8 different medical centres to complete the study."

Answered by AI

Can I participate in this clinical investigation?

"This medical trial is recruiting 165 individuals with carcinoma, non-small-cell lung aged between 18 and 130. Applicants must meet a range of criteria including: having 4 prior lines of systemic therapy for metastatic cases; having 1 measurable target lesions per RECIST 1.1.; being in an Eastern Cooperative Group (ECOG) score from 0 to 1; possessing a life expectancy of ≥ 12 weeks; meeting organ/marrow function conditions as outlined by the protocol; providing archival tissue or unstained slides if applicable; agreeing to mandatory biopsies at screening and on study for Part B participants; and lastly, those enrolled"

Answered by AI

At what geographical sites is this research endeavor taking place?

"Currently, 8 different centres are enrolling participants in this trial. These sites can be found in cities such as Atlanta, Providence and Detroit alongside 5 other locations. Choosing the closest centre will reduce any travel requirements should you choose to participate."

Answered by AI

Does this research venture currently have the capacity to admit participants?

"Clinicaltrials.gov data verifies that this medical trial, first advertised on June 7th 2022, is still recruiting participants. The information was last amended on November 10th 2022."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A First-in-human Study to Evaluate the Safety and Tolerability of AZD8853 in Participants With Selected Advanced/Metastatic Solid Tumours

2022. "A First-in-human Study to Evaluate the Safety and Tolerability of AZD8853 in Participants With Selected Advanced/Metastatic Solid Tumours". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05397171.