First in Human Study of AZD9592 in Solid Tumors

NCT05647122 · tracked via the Priya Life Science USA tracker

Sponsor

AstraZeneca

Phase

Phase 1

Started

2022-12-21

Last updated

2026-06-11

Condition(s) studied

Advanced Solid TumoursCarcinoma Non-small Cell LungHead and Neck NeoplasmsColorectal Neoplasms

Investigational drug(s) / intervention(s)

AZD9592Osimertinib5-Fluorouracil (5-FU)LeucovorinBevacizumab

AZD9592: Varying doses of AZD9592

Osimertinib: tablets administered orally

5-Fluorouracil (5-FU): IV infusion

Leucovorin: IV infusion

Bevacizumab: IV infusion

Study 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

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

Key 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 Additional Inclusion Criteria for Module 1: • Histologically or cytologically confirmed metastatic or locally advanced EGFRmut., NSCLC; metastatic EGFRwt. NSCLC; recurrent or metastatic HNSCC of the oral cavity; metastatic CRC. Additional Inclusion Criteria for Module 2: • Histologically or cytologically confirmed metastatic NSCLC EGFRmut. Additional Inclusion Criteria for Module 3: • Histologically or cytologically confirmed metastatic CRC. Key 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 2 weeks prior to start of study treatment. * Participants with cardiac comorbidities as defined in the study protocol

Primary outcome measure(s)

Incidence of Adverse Events (AEs) — From time of Informed Consent to 30 days post last dose of AZD9592
Number of patients with adverse events by system organ class and preferred term
Incidence of Serious Adverse Events (SAEs) — From time of Informed Consent to 30 days post last dose of AZD9592
Number of patients with serious adverse events by system organ class and preferred term
Incidence of dose-limiting toxicities (DLT) as defined in the protocol — From time of first dose of AZD9592 to end of DLT period (approximately 21 days)
Number of patients with at least 1 dose-limiting toxicity (DLT), which is any toxicity defined as a DLT in the Clinical Study Protocol
Incidence of baseline laboratory finding, ECG and vital signs changes — From time of Informed Consent to 30 days post last dose of AZD9592
measured by laboratory and vital sign variables over time including change from baseline
Proportion of patients with radiological response (ORR) — From date of first dose of AZD9592 up until progression, or the last evaluable assessment in the absence of progression (approximately 2 years)
Assessed by overall response rate (ORR) defined as the proportion of patients who have a confirmed complete or partial radiological response by the Investigator according to RECIST v1.1 (for patients in the dose expansion cohorts, only)

Trial sites (46)

Facility	City	Region
Research Site	Duarte	California
Research Site	North Haven	Connecticut
Research Site	Washington D.C.	District of Columbia
Research Site	Chicago	Illinois
Research Site	Baltimore	Maryland
Research Site	Baltimore	Maryland
Research Site	Milford	Massachusetts
Research Site	Mineola	New York
Research Site	New York	New York
Research Site	New York	New York
Research Site	New York	New York
Research Site	Philadelphia	Pennsylvania
Research Site	Providence	Rhode Island
Research Site	Houston	Texas
Research Site	Fairfax	Virginia
Research Site	Kogarah	Australia
Research Site	Melbourne	Australia
Research Site	Edmonton	Alberta
Research Site	Toronto	Ontario
Research Site	Beijing	China
Research Site	Chongqing	China
Research Site	Guangzhou	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	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

+ 6 more sites — see the full list on the official registry below.

On this site

📄 Tagrisso (osimertinib) drug profile → 📄 Avastin (bevacizumab) drug profile →

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05647122 on ClinicalTrials.gov ↗ ← All trials in the USA