403 Participants Needed

AZD9592 for Solid Tumors

(EGRET Trial)

Recruiting at 50 trial locations
AC
Overseen ByAstraZeneca Clinical Study Information Center
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called AZD9592 for individuals with advanced solid tumors. Researchers aim to assess the safety and effectiveness of this treatment, both alone and in combination with other cancer drugs. It is suitable for those with confirmed colorectal cancer, non-small cell lung cancer (NSCLC), or head and neck cancer. Participants should not have conditions such as lung inflammation or untreated brain metastases. The goal is to discover new ways to combat these challenging cancers and gain insights into how AZD9592 functions. As a Phase 1 trial, this research focuses on understanding the treatment's effects in people, offering participants the opportunity to be among the first to receive it.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that AZD9592 is being tested for safety in various combinations to treat solid tumors. In earlier lab studies, AZD9592 appeared safe and effective against tumors with certain proteins, such as EGFR and c-MET. However, this trial marks the first time AZD9592 is tested in humans, so its safety profile is still under evaluation.

When combined with 5-FU, Bevacizumab, and Leucovorin, studies suggest these drugs are generally well-tolerated for colorectal cancer. However, the effects of AZD9592 in this combination remain uncertain.

For the combination with Osimertinib, lab research showed positive results, but this is also its first test in humans. Osimertinib is a known treatment with an established safety record, but AZD9592 is still being evaluated.

This trial is in its early stages and primarily focuses on understanding the safety of AZD9592. Participants might experience unknown side effects, which is common in first-time human studies. As the study progresses, more safety information will become available.12345

Why are researchers excited about this trial's treatments?

Researchers are excited about AZD9592 because it offers a fresh approach to treating solid tumors. Unlike current therapies that often target tumors broadly, AZD9592 is designed to work in combination with other drugs or as a standalone treatment, potentially improving safety and effectiveness. This treatment works by targeting specific mechanisms within cancer cells, which might lead to better outcomes for patients with conditions like colorectal cancer and non-small cell lung cancer (NSCLC). By exploring its use both alone and in combination with existing drugs such as 5-FU, Bevacizumab, Leucovorin, and Osimertinib, AZD9592 could redefine how we approach these challenging cancers.

What evidence suggests that this trial's treatments could be effective for solid tumors?

Research suggests that AZD9592 shows promise in treating advanced solid tumors. In this trial, participants may receive AZD9592 as monotherapy or in combination with other drugs. Early studies have shown that AZD9592 can effectively target tumors with certain proteins, EGFR and c-MET, which help cancer cells grow. One treatment arm combines AZD9592 with 5-FU, Bevacizumab, and Leucovorin, a combination effective in treating colorectal cancer and improving survival times. Another arm combines AZD9592 with Osimertinib, a treatment for some lung cancers, which showed positive results in models with different genetic types of lung cancer, including those with EGFR mutations. Although these findings are still early, they offer hope for the treatment's potential effectiveness against various cancers.12367

Who Is on the Research Team?

CA

Charu Aggarwal

Principal Investigator

University of Pennsylvania

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

Life expectancy ≥ 12 weeks
Measurable disease per RECIST v1.1
I am fully active or can carry out light work.
See 1 more

Exclusion 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.
See 2 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive AZD9592 as monotherapy or in combination with anti-cancer agents to determine safety, tolerability, and anti-tumor activity

Approximately 2 years

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Open-label extension (optional)

Participants may opt into continuation of treatment long-term

Long-term

What Are the Treatments Tested in This Trial?

Interventions

  • AZD9592
Trial Overview 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.
How Is the Trial Designed?
3Treatment groups
Experimental Treatment
Group I: Module 3 AZD9592 Combination 5-FU, Bevacizumab, LeucovorinExperimental Treatment4 Interventions
Group II: Module 2 AZD9592 Combination with OsimertinibExperimental Treatment2 Interventions
Group III: Module 1 AZD9592 MonotherapyExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

AstraZeneca

Lead Sponsor

Trials
4,491
Recruited
290,540,000+

Sir Pascal Soriot

AstraZeneca

Chief Executive Officer since 2012

Veterinary Medicine from École nationale vétérinaire d'Alfort, MBA from HEC Paris

Dr. Cristian Massacesi

AstraZeneca

Chief Medical Officer since 2021

MD from Marche Polytechnic University, Oncology training at Royal Marsden Hospital, Kaplan Comprehensive Cancer Center, and European Institute of Oncology

Pascal Soriot

AstraZeneca

Chief Executive Officer since 2012

Veterinary Medicine from École nationale vétérinaire d'Alfort, MBA from HEC Paris

Cristian Massacesi

AstraZeneca

Chief Medical Officer since 2021

MD from Marche Polytechnic University, Medical Oncology training at Royal Marsden Hospital, Kaplan Comprehensive Cancer Center, and European Institute of Oncology

Citations

First in Human Study of AZD9592 in Solid TumorsThis is a first-in-human (FIH) Phase I, multi-center, open-label, study of AZD9592, in patients with advanced solid tumors. The study consists of several ...
2.pubmed.ncbi.nlm.nih.govpubmed.ncbi.nlm.nih.gov/23352604/
Efficacy and safety of bevacizumab-based combination ...The combination of bevacizumab and bolus 5-fluorouracil, leucovorin and irinotecan is highly effective in patients with metastatic colorectal cancer (mCRC).
First in Human Study of AZD9592 in solid tumors - EGRETThis is a first-in-human (FIH) Phase I, multi-center, open-label, study of AZD9592, in patients with advanced solid tumors.
First in Human Study of AZD9592 in Solid Tumors - Clinica...This is a first-in-human (FIH) Phase I, multi-center, open-label, study of AZD9592, in patients with advanced solid tumors.
5.pubmed.ncbi.nlm.nih.govpubmed.ncbi.nlm.nih.gov/15867200/
Combined analysis of efficacy: the addition of bevacizumab ...Results: The median duration of survival was 17.9 months in the FU/LV/bevacizumab group, compared with 14.6 months in the combined control group, corresponding ...
Current and emerging concepts for systemic treatment of ...AZD9592+5- FU/ leucovorin+ ... Reduction of Liver Metastasis Stiffness Improves. Response to Bevacizumab in Metastatic Colorectal Cancer.
Clinical Trials Appendix• Sub-study 5b: Datroway + 5-FU/leucovorin or Capecitabine. + ... • Arm 3: AZD9592 + 5FU + bevacizumab. • Primary endpoints (escalation): ...
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