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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
- Histologically or cytologically confirmed locally advanced, unresectable or metastatic NSCLC, MSS-CRC, or UC.
- Documented progression from previous therapy
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
No Placebo-Only Group

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

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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You have been diagnosed with advanced lung cancer, colorectal cancer, or urinary bladder cancer that has spread and cannot be surgically removed.
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Your previous treatment did not work and your condition has gotten worse.
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You have received at least one type of treatment for your advanced or metastatic condition.
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You have previously been treated with a specific type of medication called anti-PD-1/anti-PD-L1, either on its own or along with chemotherapy.
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You have advanced or metastatic colorectal cancer and have already tried at least two different types of treatment for it.

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

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

Find a Location

Who is running the clinical trial?

AstraZenecaLead Sponsor
4,217 Previous Clinical Trials
289,739,756 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
~6 spots leftby Feb 2025