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First in Human Study of AZD9592 in Solid Tumors

NCT ID: NCT05647122

Last Updated: 2025-11-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE1

Total Enrollment

403 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-12-22

Study Completion Date

2027-10-06

Brief Summary

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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.

Detailed Description

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Conditions

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Advanced Solid Tumours Carcinoma Non-small Cell Lung Head and Neck Neoplasms Colorectal Neoplasms

Keywords

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Cancer First in Human Antibody Drug Conjugate Solid Tumour Phase I

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Module 1 AZD9592 Monotherapy

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

Group Type EXPERIMENTAL

AZD9592

Intervention Type DRUG

Varying doses of AZD9592

Module 2 AZD9592 Combination with Osimertinib

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 Type EXPERIMENTAL

AZD9592

Intervention Type DRUG

Varying doses of AZD9592

Osimertinib

Intervention Type DRUG

tablets administered orally

Module 3 AZD9592 Combination 5-FU, Bevacizumab, Leucovorin

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 Type EXPERIMENTAL

AZD9592

Intervention Type DRUG

Varying doses of AZD9592

5-Fluorouracil (5-FU)

Intervention Type DRUG

IV infusion

Leucovorin

Intervention Type DRUG

IV infusion

Bevacizumab

Intervention Type DRUG

IV infusion

Interventions

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AZD9592

Varying doses of AZD9592

Intervention Type DRUG

Osimertinib

tablets administered orally

Intervention Type DRUG

5-Fluorouracil (5-FU)

IV infusion

Intervention Type DRUG

Leucovorin

IV infusion

Intervention Type DRUG

Bevacizumab

IV infusion

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Age ≥ 18 years
* Eastern Cooperative Oncology Group (ECOG) Performance Status: 0-1
* Life expectancy ≥ 12 weeks
* Measurable disease per RECIST v1.1
* Adequate organ and marrow function as defined in the protocol


• Histologically or cytologically confirmed metastatic or locally advanced EGFRmut., NSCLC; metastatic EGFRwt. NSCLC; recurrent or metastatic HNSCC of the oral cavity; metastatic CRC.


• Histologically or cytologically confirmed metastatic NSCLC EGFRmut.


• Histologically or cytologically confirmed metastatic CRC.

Exclusion Criteria

* History of (non-infectious) ILD/pneumonitis that required steroids, has current ILD/pneumonitis, or where suspected ILD/pneumonitis cannot be ruled out by imaging at screening.
* Spinal cord compression or a history of leptomeningeal carcinomatosis.
* Active infection including tuberculosis and HBV, HCV or HIV
* Brain metastases unless treated (prior treatment required only for Module 1), asymptomatic, stable, and not requiring continuous corticosteroids at a dose of \> 10 mg prednisone/day or equivalent for at least 4 weeks prior to start of study treatment.
* Participants with cardiac comorbidities as defined in the study protocol
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AstraZeneca

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Charu Aggarwal, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

University of Pennsylvania

Locations

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Research Site

Duarte, California, United States

Site Status RECRUITING

Research Site

Irvine, California, United States

Site Status WITHDRAWN

Research Site

North Haven, Connecticut, United States

Site Status RECRUITING

Research Site

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

Site Status RECRUITING

Research Site

Chicago, Illinois, United States

Site Status RECRUITING

Research Site

Baltimore, Maryland, United States

Site Status RECRUITING

Research Site

Baltimore, Maryland, United States

Site Status RECRUITING

Research Site

Milford, Massachusetts, United States

Site Status RECRUITING

Research Site

Mineola, New York, United States

Site Status RECRUITING

Research Site

New York, New York, United States

Site Status RECRUITING

Research Site

New York, New York, United States

Site Status RECRUITING

Research Site

New York, New York, United States

Site Status RECRUITING

Research Site

Philadelphia, Pennsylvania, United States

Site Status RECRUITING

Research Site

Providence, Rhode Island, United States

Site Status RECRUITING

Research Site

Houston, Texas, United States

Site Status RECRUITING

Research Site

Fairfax, Virginia, United States

Site Status RECRUITING

Research Site

Kogarah, , Australia

Site Status RECRUITING

Research Site

Melbourne, , Australia

Site Status RECRUITING

Research Site

Edmonton, Alberta, Canada

Site Status RECRUITING

Research Site

Toronto, Ontario, Canada

Site Status RECRUITING

Research Site

Beijing, , China

Site Status RECRUITING

Research Site

Beijing, , China

Site Status NOT_YET_RECRUITING

Research Site

Chongqing, , China

Site Status RECRUITING

Research Site

Guangzhou, , China

Site Status RECRUITING

Research Site

Harbin, , China

Site Status NOT_YET_RECRUITING

Research Site

Wuhan, , China

Site Status RECRUITING

Research Site

Marseille, , France

Site Status RECRUITING

Research Site

Rennes, , France

Site Status RECRUITING

Research Site

Villejuif, , France

Site Status RECRUITING

Research Site

Milan, , Italy

Site Status RECRUITING

Research Site

Orbassano, , Italy

Site Status RECRUITING

Research Site

Rozzano, , Italy

Site Status RECRUITING

Research Site

Verona, , Italy

Site Status RECRUITING

Research Site

Chūōku, , Japan

Site Status RECRUITING

Research Site

Kashiwa, , Japan

Site Status RECRUITING

Research Site

Kōtoku, , Japan

Site Status RECRUITING

Research Site

Osaka, , Japan

Site Status NOT_YET_RECRUITING

Research Site

Kuala Lumpur, , Malaysia

Site Status NOT_YET_RECRUITING

Research Site

Kuching, , Malaysia

Site Status RECRUITING

Research Site

Seoul, , South Korea

Site Status RECRUITING

Research Site

Seoul, , South Korea

Site Status RECRUITING

Research Site

Seoul, , South Korea

Site Status RECRUITING

Research Site

Seoul, , South Korea

Site Status RECRUITING

Research Site

Barcelona, , Spain

Site Status RECRUITING

Research Site

Madrid, , Spain

Site Status RECRUITING

Research Site

Seville, , Spain

Site Status RECRUITING

Research Site

Taichung, , Taiwan

Site Status RECRUITING

Research Site

Taipei, , Taiwan

Site Status RECRUITING

Research Site

Taipei, , Taiwan

Site Status RECRUITING

Research Site

Taoyuan District, , Taiwan

Site Status RECRUITING

Countries

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United States Australia Canada China France Italy Japan Malaysia South Korea Spain Taiwan

Central Contacts

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AstraZeneca Clinical Study Information Center

Role: CONTACT

Phone: 1-877-240-9479

Email: [email protected]

Other Identifiers

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2022-501570-18-00

Identifier Type: REGISTRY

Identifier Source: secondary_id

D9350C00001

Identifier Type: -

Identifier Source: org_study_id