AZD9592 for Solid Tumors

(EGRET Trial)

Recruiting at37 trial locations

Overseen by Charu Aggarwal

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Recruiting

Sponsor: AstraZeneca

Must not be taking: Corticosteroids

Disqualifiers: ILD/pneumonitis, Spinal cord compression, Active infection, Brain metastases, Cardiac comorbidities, others

No Placebo Group

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?

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.

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.

Research Team

Charu Aggarwal

Principal Investigator

University of Pennsylvania

Eligibility Criteria

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.

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.

Trial Timeline

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

Treatment Details

Interventions

• AZD9592 (Unknown)

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.

Participant Groups

Group I: Module 3 AZD9592 Combination 5-FU, Bevacizumab, Leucovorin Experimental Treatment 4 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 Osimertinib Experimental Treatment 2 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 Monotherapy Experimental Treatment 1 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

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