First in Human Study of AZD9592 in Solid Tumors

Description

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.

Conditions

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

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Study Overview

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Study Details

Study overview

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.

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

First in Human Study of AZD9592 in Solid Tumors

Condition
Advanced Solid Tumours
Intervention / Treatment

-

Contacts and Locations

Duarte

Research Site, Duarte, California, United States, 91010

Irvine

Research Site, Irvine, California, United States, 92618

North Haven

Research Site, North Haven, Connecticut, United States, 06473

Washington

Research Site, Washington, District of Columbia, United States, 20016

Chicago

Research Site, Chicago, Illinois, United States, 60637

Baltimore

Research Site, Baltimore, Maryland, United States, 21224

Baltimore

Research Site, Baltimore, Maryland, United States, 21231

Milford

Research Site, Milford, Massachusetts, United States, 01757

Mineola

Research Site, Mineola, New York, United States, 11501

New York

Research Site, New York, New York, United States, 10016

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

AstraZeneca,

Charu Aggarwal, MD, MPH, PRINCIPAL_INVESTIGATOR, University of Pennsylvania

Study Record Dates

2025-12-24