RECRUITING

First in Human Study of AZD9592 in Solid Tumors

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2022-12-22
Study Completion:2025-12-24
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05647122

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Age ≥ 18 years
  2. * Eastern Cooperative Oncology Group (ECOG) Performance Status: 0-1
  3. * Life expectancy ≥ 12 weeks
  4. * Measurable disease per RECIST v1.1
  5. * Adequate organ and marrow function as defined in the protocol
  1. * 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.
  2. * Spinal cord compression or a history of leptomeningeal carcinomatosis.
  3. * Active infection including tuberculosis and HBV, HCV or HIV
  4. * 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.
  5. * Participants with cardiac comorbidities as defined in the study protocol

Contacts and Locations

Study Contact

AstraZeneca Clinical Study Information Center
CONTACT
1-877-240-9479
information.center@astrazeneca.com

Principal Investigator

Charu Aggarwal, MD, MPH
PRINCIPAL_INVESTIGATOR
University of Pennsylvania

Study Locations (Sites)

Research Site
Duarte, California, 91010
United States
Research Site
Irvine, California, 92618
United States
Research Site
North Haven, Connecticut, 06473
United States
Research Site
Washington, District of Columbia, 20016
United States
Research Site
Chicago, Illinois, 60637
United States
Research Site
Baltimore, Maryland, 21224
United States
Research Site
Baltimore, Maryland, 21231
United States
Research Site
Milford, Massachusetts, 01757
United States
Research Site
Mineola, New York, 11501
United States
Research Site
New York, New York, 10016
United States
Research Site
New York, New York, 10021
United States
Research Site
New York, New York, 10029
United States
Research Site
Philadelphia, Pennsylvania, 19104
United States
Research Site
Providence, Rhode Island, 02903
United States
Research Site
Houston, Texas, 77030
United States
Research Site
Fairfax, Virginia, 22031
United States

Collaborators and Investigators

Sponsor: AstraZeneca

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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-12-22
Study Completion Date2025-12-24

Study Record Updates

Study Start Date2022-12-22
Study Completion Date2025-12-24

Terms related to this study

Keywords Provided by Researchers

  • Cancer
  • First in Human
  • Antibody Drug Conjugate
  • Solid Tumour
  • Phase I

Additional Relevant MeSH Terms

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