RecruitingPhase 1NCT05647122

First in Human Study of AZD9592 in Solid Tumors

A Phase I, Multicenter, Open-label, First-in-Human, Dose Escalation and Expansion Study of AZD9592 as Monotherapy and in Combination With Anti-cancer Agents in Patients With Advanced Solid Tumors

Sponsor

AstraZeneca

Enrollment

403 participants

Start Date

Dec 21, 2022

Study Type

INTERVENTIONAL

Conditions

Advanced Solid Tumours

Summary

This 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 study modules, each evaluating the safety, tolerability, preliminary efficacy, pharmacokinetics (PK), pharmacodynamics, anti-tumor activity, and immunogenicity of AZD9592, as monotherapy or in combination with anti-cancer agents.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This is a first-in-human study testing a new cancer drug called AZD9592, which targets two proteins (EGFR and MET) found on certain solid tumors. The goal is to find a safe dose and see early signs of whether the drug works. **You may be eligible if...** - You are 18 or older with a solid tumor cancer (such as lung cancer with EGFR or MET mutations) - You have tried prior standard treatments without success - You are in reasonably good health with adequate organ function - Your cancer is measurable on scans **You may NOT be eligible if...** - You have certain brain metastases (unless stable) - You have had recent major surgery or certain prior treatments - You have significant heart, liver, or kidney problems Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGAZD9592

Varying doses of AZD9592

DRUGOsimertinib

tablets administered orally

DRUG5-Fluorouracil (5-FU)

IV infusion

DRUGLeucovorin

IV infusion

DRUGBevacizumab

IV infusion

Locations(50)

Research Site

Duarte, California, United States

Research Site

Irvine, California, United States

Research Site

North Haven, Connecticut, United States

Research Site

Washington D.C., District of Columbia, United States

Research Site

Chicago, Illinois, United States

Research Site

Baltimore, Maryland, United States

Research Site

Baltimore, Maryland, United States

Research Site

Milford, Massachusetts, United States

Research Site

Mineola, New York, United States

Research Site

New York, New York, United States

Research Site

New York, New York, United States

Research Site

New York, New York, United States

Research Site

Philadelphia, Pennsylvania, United States

Research Site

Providence, Rhode Island, United States

Research Site

Houston, Texas, United States

Research Site

Fairfax, Virginia, United States

Research Site

Kogarah, Australia

Research Site

Melbourne, Australia

Research Site

Edmonton, Alberta, Canada

Research Site

Toronto, Ontario, Canada

Research Site

Beijing, China

Research Site

Beijing, China

Research Site

Chongqing, China

Research Site

Guangzhou, China

Research Site

Harbin, China

Research Site

Wuhan, China

Research Site

Marseille, France

Research Site

Rennes, France

Research Site

Villejuif, France

Research Site

Milan, Italy

Research Site

Orbassano, Italy

Research Site

Rozzano, Italy

Research Site

Verona, Italy

Research Site

Chūōku, Japan

Research Site

Kashiwa, Japan

Research Site

Kōtoku, Japan

Research Site

Osaka, Japan

Research Site

Kuala Lumpur, Malaysia

Research Site

Kuching, Malaysia

Research Site

Seoul, South Korea

Research Site

Seoul, South Korea

Research Site

Seoul, South Korea

Research Site

Seoul, South Korea

Research Site

Barcelona, Spain

Research Site

Madrid, Spain

Research Site

Seville, Spain

Research Site

Taichung, Taiwan

Research Site

Taipei, Taiwan

Research Site

Taipei, Taiwan

Research Site

Taoyuan, Taiwan

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NCT05647122

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