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 first dose until study end (1 year)

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new drug called AZD8853 to see if it is safe and effective for patients with advanced lung, colorectal, and bladder cancers. Researchers are studying how the drug interacts with the body and whether it can help control or shrink tumors.

Eligible Conditions

Bladder Cancer
Non-Small Cell Lung Cancer
Colorectal Cancer

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ first dose until study end (1 year)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~first dose until study end (1 year)

This trial's timeline: 3 weeks for screening, Varies for treatment, and first dose until study end (1 year) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Number of Participants With Dose Limiting Toxicity (DLT)

Number of Participants With Treatment-emergent Adverse Events (TEAEs)

Secondary study objectives

Area Under the Plasma Concentration-time Curve From Zero to Infinity (AUCinf) of AZD8853

Area Under the Plasma Concentration-time Curve From Zero to the Last Quantifiable Concentration (AUClast) of AZD8853

Disease Control Rate (DCR) at 15 Weeks

+10 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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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