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First in Human Study of AZD9592 in Solid Tumors
First in Human Study of AZD9592 in Solid Tumors

NCT05647122

Active Not RecruitingPhase 1

Sponsor: AstraZeneca

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

Interventions: AZD9592, Osimertinib, 5-Fluorouracil (5-FU), Leucovorin, Bevacizumab

Countries: United States, Australia, Canada, China, France, Italy, Japan, Malaysia

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 overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria
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
Locations (46)
  • Duarte, California, United States
  • North Haven, Connecticut, United States
  • Washington D.C., District of Columbia, United States
  • Chicago, Illinois, United States
  • Baltimore, Maryland, United States
  • Baltimore, Maryland, United States
  • Milford, Massachusetts, United States
  • Mineola, New York, United States
  • New York, New York, United States
  • New York, New York, United States
  • New York, New York, United States
  • Philadelphia, Pennsylvania, United States
  • Providence, Rhode Island, United States
  • Houston, Texas, United States
  • Fairfax, Virginia, United States
  • Kogarah, Australia
  • Melbourne, Australia
  • Edmonton, Alberta, Canada
  • Toronto, Ontario, Canada
  • Beijing, China
  • Chongqing, China
  • Guangzhou, China
  • Wuhan, China
  • Marseille, France
  • Rennes, France
  • Villejuif, France
  • Milan, Italy
  • Orbassano, Italy
  • Rozzano, Italy
  • Verona, Italy
  • + 16 more on CT.gov