← Back to Search

Unknown

AZD9592 for Solid Tumors (EGRET Trial)

Phase 1

Recruiting

Led By Charu Aggarwal, MD, MPH

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 date of first dose of azd9592 up until the date of death due to any cause (approximately 2 years)

Awards & highlights

EGRET Trial Summary

This trial evaluates the safety and effectiveness of AZD9592 to treat advanced solid tumors. It looks at how it works, how it affects the body, and potential side effects.

Who is the study for?

Adults over 18 with advanced solid tumors, able to perform daily activities (ECOG 0-1), and expected to live at least 12 weeks can join. They must have measurable disease and good organ/marrow function. Those with active infections, brain metastases not treated/stable, certain heart issues, a history of lung inflammation needing steroids or current lung inflammation are excluded.Check my eligibility

What is being tested?

The trial is testing AZD9592's safety and effectiveness alone or with other cancer drugs in patients with advanced solid tumors. It will assess how the body processes AZD9592 and its impact on tumors through various study modules.See study design

What are the potential side effects?

Potential side effects include typical reactions to cancer medications such as nausea, fatigue, increased risk of infection due to lowered immunity from marrow suppression, possible liver or kidney function changes, and potential for allergic reactions.

EGRET Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from date of first dose of azd9592 up until the date of death due to any cause (approximately 2 years)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from date of first dose of azd9592 up until the date of death due to any cause (approximately 2 years)

This trial's timeline: 3 weeks for screening, Varies for treatment, and from date of first dose of azd9592 up until the date of death due to any cause (approximately 2 years) for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Incidence of Adverse Events (AEs)

Incidence of Serious Adverse Events (SAEs)

Incidence of baseline laboratory finding, ECG and vital signs changes

+2 more

Secondary outcome measures

Disease Control Rate (DCR) at 12 weeks

Duration of Response (DoR)

Immunogenicity of AZD9592: Anti-Drug Antibodies (ADA)

+9 more

EGRET Trial Design

3Treatment groups

Experimental Treatment

Group I: Module 3 AZD9592 Combination 5-FU, Bevacizumab, LeucovorinExperimental Treatment4 Interventions

Module 3 has two parts: Part A aims to determine the safety, tolerability and/or recommended phase 2 dose (RP2D) of AZD9592 in combination with 5-FU, Bevacizumab, Leucovorin in Colorectal Cancer (CRC) Part B aims to determine the safety, tolerability and evaluate anti-tumor activity of AZD9592 in combination with 5-FU, Bevacizumab, Leucovorin in Colorectal Cancer (CRC)

Group II: Module 2 AZD9592 Combination with OsimertinibExperimental Treatment2 Interventions

Module 2 has two parts: Part A aims to determine the safety, tolerability, maximum tolerated dose (MTD) and/or recommended phase 2 dose (RP2D) of AZD9592 in combination with Osimertinib. Part B aims to determine the safety, tolerability and evaluate anti-tumor activity of AZD9592 in combination with Osimertinib in NSCLC EGFRm

Group III: Module 1 AZD9592 MonotherapyExperimental Treatment1 Intervention

Module 1 has two parts: Part A aims to determine the safety, tolerability, maximum tolerated dose (MTD) and/or recommended phase 2 dose (RP2D) of AZD9592. Part B aims to determine the safety, tolerability and evaluate anti-tumor activity of AZD9592 as monotherapy in select solid tumors

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

5-Fluorouracil (5-FU)

2003

Completed Phase 3

~5560

Bevacizumab

2013

Completed Phase 4

~5280

Leucovorin

2005

Completed Phase 4

~5730

Osimertinib

2017

Completed Phase 4

~1010

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

AstraZenecaLead Sponsor

4,270 Previous Clinical Trials

288,612,948 Total Patients Enrolled

Charu Aggarwal, MD, MPHPrincipal InvestigatorUniversity of Pennsylvania

2 Previous Clinical Trials

498 Total Patients Enrolled

Media Library

AZD9592 (Unknown) Clinical Trial Eligibility Overview. Trial Name: NCT05647122 — Phase 1

Solid Tumors Research Study Groups: Module 3 AZD9592 Combination 5-FU, Bevacizumab, Leucovorin, Module 1 AZD9592 Monotherapy, Module 2 AZD9592 Combination with Osimertinib

Solid Tumors Clinical Trial 2023: AZD9592 Highlights & Side Effects. Trial Name: NCT05647122 — Phase 1

AZD9592 (Unknown) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05647122 — Phase 1

Frequently Asked Questions

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

Has the FDA granted approval for AZD9592 as a single-treatment option?

"We have rated Module 1 AZD9592 Monotherapy as a 1 on our safety scale due to the scarcity of clinical data backing both its efficacy and security."

Answered by AI

Is recruitment still active for this clinical trial?

"The published information on clinicaltrials.gov reveals that this specific medical study is no longer actively recruiting patients - the last time it was edited was December 2nd 2022. Nonetheless, there are 415 other trials currently searching for participants."

Answered by AI

Has the survey been conducted in multiple locations throughout this city?

"This ongoing clinical trial has locations in Houston, Fairfax and Providence along with 8 other cities. If you wish to join the study, it is advisable to select a site closest your residence for minimal travel requirements."

Answered by AI

What are the chief goals of this clinical investigation?

"The primary measure of success for this trial, monitored between the time a patient gives informed consent and 30 days after their last dose of AZD9592, is assessing the proportion of patients with radiological response (ORR). Secondary objectives encompass measuring peak plasma concentration levels (C-max), clearance rate from circulation, as well as objectively determining complete or partial responses based on RECIST v1.1 criteria in solid tumours (Objective Response Rate - ORR)."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

First in Human Study of AZD9592 in Solid Tumors

2022. "First in Human Study of AZD9592 in Solid Tumors". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05647122.

All > Colorectal Cancer San Diego > Bowel Cancer