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First in Human Study of AZD9592 in Solid Tumors

NCT05647122 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 403

Last updated 2026-05-11

No results posted yet for this 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.

Conditions

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

Interventions

DRUG

AZD9592

Varying doses of AZD9592

DRUG

Osimertinib

tablets administered orally

DRUG

5-Fluorouracil (5-FU)

IV infusion

DRUG

Leucovorin

IV infusion

DRUG

Bevacizumab

IV infusion

Sponsors & Collaborators

Principal Investigators

  • Charu Aggarwal, MD, MPH · University of Pennsylvania

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-12-21
Primary Completion
2028-08-02
Completion
2028-08-02
FDA Drug
Yes

Countries

  • United States
  • Australia
  • Canada
  • China
  • France
  • Italy
  • Japan
  • Malaysia
  • South Korea
  • Spain
  • Taiwan

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05647122 on ClinicalTrials.gov