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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
No Placebo-Only Group
Summary
This trial is testing a new drug called AZD9592 in patients with advanced solid tumors. The goal is to see if AZD9592 can help treat these cancers, either on its own or with other treatments. Researchers are looking at how safe the drug is, how well patients tolerate it, and if it can shrink or stop the growth of tumors.
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.
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.
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.
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)
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Incidence of Adverse Events (AEs)
Incidence of Serious Adverse Events (SAEs)
Incidence of baseline laboratory finding, ECG and vital signs changes
+2 moreSecondary study objectives
Disease Control Rate (DCR) at 12 weeks
Duration of Response (DoR)
Immunogenicity of AZD9592: Anti-Drug Antibodies (ADA)
+9 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
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
Leucovorin
2005
Completed Phase 4
~6010
Bevacizumab
2013
Completed Phase 4
~5540
Osimertinib
2017
Completed Phase 4
~1100
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for solid tumors include chemotherapy, targeted therapy, and immunotherapy. Chemotherapy kills rapidly dividing cells, including cancer cells, but can also affect normal cells.
Targeted therapies, such as tyrosine kinase inhibitors, specifically target molecular pathways crucial for tumor growth and survival, minimizing damage to normal cells. Immunotherapy, like checkpoint inhibitors, enhances the body's immune response against cancer cells.
These mechanisms are crucial for selecting the most appropriate treatment based on the tumor's characteristics and the patient's health.
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Who is running the clinical trial?
AstraZenecaLead Sponsor
4,388 Previous Clinical Trials
289,109,580 Total Patients Enrolled
Charu Aggarwal, MD, MPHPrincipal InvestigatorUniversity of Pennsylvania
2 Previous Clinical Trials
415 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have had spinal cord compression or cancer spread to the lining of my brain.I have heart conditions as outlined in the study details.I have or had lung inflammation treated with steroids, or it's suspected but not confirmed by scans.I am fully active or can carry out light work.I have brain metastases that are treated, stable, and I'm not on high-dose steroids.My organs and bone marrow are working well.I do not have active infections like TB, hepatitis B or C, or HIV.I am 18 years old or older.
Research Study Groups:
This trial has the following groups:- Group 1: Module 3 AZD9592 Combination 5-FU, Bevacizumab, Leucovorin
- Group 2: Module 1 AZD9592 Monotherapy
- Group 3: Module 2 AZD9592 Combination with Osimertinib
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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