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Clinical Trials in France / NCT05647122
Active, not recruiting Phase 1

First in Human Study of AZD9592 in Solid Tumors

NCT05647122 · tracked via the Priya Life Science France tracker
Sponsor
AstraZeneca
Phase
Phase 1
Started
2022-12-21
Last updated
2026-09-25

Condition(s) studied

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

Investigational drug(s) / intervention(s)

AZD9592 →Osimertinib →5-Fluorouracil (5-FU) →Leucovorin →Bevacizumab →

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
No
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)

FacilityCityRegionStatus
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 →

More AstraZeneca trials in France

Savolitinib vs. Sunitinib in MET-driven PRCC. Active, not recruiting
A Study to Evaluate Effect of AZD6234 in Adult Participants With Obesity or Overweight With Weight-related Comorbidity Without Type 2 Diabetes Mellitus Recruiting
PRostate Olaparib Real World Evidence Study Active, not recruiting
A Study of T-DXd for the Treatment of Solid Tumors Harboring HER2 Activating Mutations Active, not recruiting
Study of MEDI4736 (Durvalumab) With or Without Tremelimumab Versus Standard of Care Chemotherapy in Urothelial Cancer Active, not recruiting

Other trials for the same condition

Study of Pembrolizumab Given Prior to Surgery and in Combination With Radiotherapy Given Post-surgery for Advanced Head and Neck Squamous Cell Carcinoma (MK-3475-689) Active, not recruiting
Basket Study of Entrectinib (RXDX-101) for the Treatment of Patients With Solid Tumors Harboring NTRK 1/2/3 (Trk A/B/C), ROS1, or ALK Gene Rearrangements (Fusions) Active, not recruiting
A Study of Tucatinib With Trastuzumab and mFOLFOX6 Versus Standard of Care Treatment in First-line HER2+ Metastatic Colorectal Cancer Recruiting
A Study of SGN-CEACAM5C in Adults With Advanced Solid Tumors Recruiting
Liquid Biopsy in Early Colorectal Lesions Starting soon
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 France