What side effects are associated with this type of intervention?

Common treatments for solid tumors, such as tyrosine kinase inhibitors, immune checkpoint inhibitors, and chemotherapeutic agents, often have a range of side effects. Tyrosine kinase inhibitors can cause hypertension, hypothyroidism, diarrhea, and fatigue. Immune checkpoint inhibitors may lead to immune-related adverse events like colitis, pneumonitis, and dermatitis. Chemotherapeutic agents frequently result in myelosuppression, leading to neutropenia, anemia, and thrombocytopenia, as well as gastrointestinal symptoms like nausea and vomiting. These side effects are generally manageable but require careful monitoring and supportive care.

What prior FDA approvals exist?

The FDA has approved several drugs targeting tumor growth and progression in solid tumors. Notable examples include pembrolizumab and nivolumab, which are immune checkpoint inhibitors targeting PD-1, and atezolizumab, targeting PD-L1. These drugs have shown efficacy in various solid tumors, including non-small cell lung cancer, renal cell carcinoma, and melanoma. Additionally, bevacizumab, an anti-VEGF antibody, has been approved for use in multiple solid tumors, including colorectal cancer and non-small cell lung cancer, due to its ability to inhibit angiogenesis. These treatments share a common goal with AZD9592 in targeting mechanisms that promote tumor growth and survival.

What other types of research exist?

Promising novel alternatives to AZD9592 for solid tumor patients include: 1) Cabozantinib, which has shown efficacy in various solid tumors including renal cell carcinoma and osteosarcoma. 2) Regorafenib, which has demonstrated efficacy in metastatic osteosarcoma. 3) AZD0156, an ATM inhibitor that potentiates the effects of irradiation and olaparib in preclinical studies. 4) AZD4877, an Eg5 inhibitor with an acceptable tolerability profile in solid tumors. 5) AZD4635, an adenosine A2A receptor antagonist, which has shown objective responses in combination with durvalumab in solid tumors.

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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)

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

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 more

Secondary study objectives

Disease Control Rate (DCR) at 12 weeks

Duration of Response (DoR)

Immunogenicity of AZD9592: Anti-Drug Antibodies (ADA)

+9 more

Awards & 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

~1120

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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.