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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 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

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Who is running the clinical trial?

AstraZenecaLead Sponsor
4,287 Previous Clinical Trials
288,620,120 Total Patients Enrolled
ImaginAb, Inc.Industry Sponsor
12 Previous Clinical Trials
284 Total Patients Enrolled
~5 spots leftby May 2025
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