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Checkpoint Inhibitor

MEDI9253 + Durvalumab for Solid Cancers

Phase 1
Waitlist Available
Research Sponsored by AstraZeneca
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Body weight > 35 kg at screening
Participant must be at least 18 years old at signing of informed consent
Timeline
Screening 3 weeks
Treatment Varies
Follow Up informed consent through 90-post last dose, estimated to be 6 months
Awards & highlights

Study Summary

This trial is testing a new drug, MEDI9253, in combination with durvalumab to see if it is safe and effective in treating adults with certain types of advanced solid tumors.

Who is the study for?
This trial is for adults over 18 with a body weight above 35 kg who have certain advanced or metastatic solid tumors. It's not for those with primary brain tumors, untreated or uncontrolled brain metastases, leptomeningeal disease, spinal cord compression, or those needing steroids to control brain disease.Check my eligibility
What is being tested?
The study tests MEDI9253 combined with Durvalumab in people with specific solid tumors. It's the first time this combo is being tried on humans (Phase 1). The goal is to find out how safe it is and how bodies handle it (dose escalation/expansion).See study design
What are the potential side effects?
While the exact side effects aren't listed here, typical ones from drugs like MEDI9253 and Durvalumab include immune-related reactions affecting organs, infusion reactions similar to allergic responses, fatigue, nausea, and increased risk of infections.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My body weight is over 35 kg.
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I am 18 years old or older.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~informed consent through 90-post last dose, estimated to be 6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and informed consent through 90-post last dose, estimated to be 6 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of participants experiencing adverse events (AEs) /serious adverse events (SAEs)
Number of participants experiencing adverse events (AEs) leading to discontinuation
Number of participants with Dose Limiting Toxicities (DLTs) of the MEDI9253 during the dose escalation phase
Secondary outcome measures
Duration of Response ( DoR)
Evaluate Disease Control Rate (DCR)
IL-12 plasma concentrations
+7 more

Trial Design

3Treatment groups
Experimental Treatment
Group I: Single dose MEDI9253, sequential DurvalumabExperimental Treatment2 Interventions
Various dose level cohorts for single dose MEDI9253 with sequential Durvalumab dosing
Group II: Multiple dose MEDI9253, sequential DurvalumabExperimental Treatment2 Interventions
Various dose level cohorts for multiple dose MEDI9253 with sequential Durvalumab dosing;
Group III: Multiple dose MEDI9253, concurrent DurvalumabExperimental Treatment2 Interventions
Various dose level cohorts for multiple dose MEDI9253 with concurrent Durvalumab dosing.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Durvalumab
2017
Completed Phase 2
~3870

Find a Location

Who is running the clinical trial?

AstraZenecaLead Sponsor
4,257 Previous Clinical Trials
288,593,749 Total Patients Enrolled

Media Library

Durvalumab (Checkpoint Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT04613492 — Phase 1
Solid Tumors Research Study Groups: Single dose MEDI9253, sequential Durvalumab, Multiple dose MEDI9253, sequential Durvalumab, Multiple dose MEDI9253, concurrent Durvalumab
Solid Tumors Clinical Trial 2023: Durvalumab Highlights & Side Effects. Trial Name: NCT04613492 — Phase 1
Durvalumab (Checkpoint Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04613492 — Phase 1

Frequently Asked Questions

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

Are elderly participants being considered for this experiment?

"This clinical trial has a wide eligibility window and is recruiting individuals aged 18 to 101."

Answered by AI

Are there any available opportunities for participants to join this research endeavor?

"Confirmed. According to the clinicaltrials.gov database, this research initiative was first advertised on December 2nd 2020 and is currently accepting participants. A total of 86 individuals from 15 trial sites are needed for completion."

Answered by AI

To what extent has MEDI9253 been assessed in previous clinical experiments?

"Currently, 333 MEDI9253 studies are underway with 52 of those in Phase 3. Cordoba, Texas is a base for many trials, but there are 12961 other sites that host research on this medication."

Answered by AI

What afflictions is MEDI9253 typically utilized to treat?

"MEDI9253 is generally prescribed to patients with non-small cell lung cancer in stage III who are not eligible for surgery. This pharmacological agent can also be utilized on those with metastatic urothelial carcinoma and advanced directives."

Answered by AI

Has the FDA authorized MEDI9253 for public consumption?

"Our team of experts at Power gives MEDI9253 a score of 1 since this is only in its first phase, and thus there is limited evidence for both safety and efficacy."

Answered by AI

How many individuals are taking part in this exploration?

"Affirmative. According to the available clinical trials data, this medical study is currently recruiting participants. This trial was initially posted on December 2nd 2020 and has since then been updated a few times with its most recent update being November 18th 2022. The research endeavour aims to recruit 86 patients from 15 distinct locations."

Answered by AI

How widespread is the implementation of this clinical trial?

"Patients are currently being recruited at 15 different sites, which include Huntersville, Providence and La Jolla among many others. Choosing the closest location is advised to reduce travel needs for potential participants."

Answered by AI

What goals is this trial striving to achieve?

"This clinical trial's primary purpose is to measure the number of participants experiencing adverse events (AEs) or serious adverse events (SAEs). Secondary objectives are Overall Survival, Disease Control Rate and Overall Response Rate, which will be calculated based on RECIST v1.1 criteria over single dose cohorts for 14 days or multiple dose cohorts for 28 days."

Answered by AI

Does this research endeavor offer me the opportunity to volunteer?

"The protocol for this trial necessitates that applicants have cancer and are between 18 to 101 years old. A total of 86 individuals will be admitted into the study."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
A Study of MEDI9253 in Combination With Durvalumab in Select Solid Tumors
2020. "A Study of MEDI9253 in Combination With Durvalumab in Select Solid Tumors". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04613492.
~6 spots leftby Nov 2024
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