Actively Recruiting

Phase 1
Age: 18Years +
All Genders
NCT05647122

First in Human Study of AZD9592 in Solid Tumors

Led by AstraZeneca · Updated on 2026-05-11

403

Participants Needed

51

Research Sites

293 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

First in Human Study of AZD9592 in Solid Tumors

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 years or older
  • ECOG Performance Status of 0 or 1
  • Life expectancy of at least 12 weeks
  • Measurable disease according to RECIST v1.1
  • Adequate organ and bone marrow function as defined in the study protocol
  • For Module 1: Confirmed metastatic or locally advanced EGFR mutant or wild-type non-small cell lung cancer, recurrent or metastatic head and neck squamous cell carcinoma of the oral cavity, or metastatic colorectal cancer
  • For Module 2: Confirmed metastatic EGFR mutant non-small cell lung cancer
  • For Module 3: Confirmed metastatic colorectal cancer
Not Eligible

You will not qualify if you...

  • History of non-infectious interstitial lung disease or pneumonitis requiring steroids, current interstitial lung disease or pneumonitis, or suspected cases not ruled out by imaging
  • Spinal cord compression or history of leptomeningeal carcinomatosis
  • Active infections including tuberculosis, hepatitis B, hepatitis C, or HIV
  • Brain metastases unless treated (prior treatment required for Module 1), asymptomatic, stable, and not needing continuous corticosteroids above 10 mg prednisone daily or equivalent for at least 4 weeks before treatment
  • Cardiac conditions as defined in the study protocol

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 51 locations

1

Research Site

Duarte, California, United States, 91010

Actively Recruiting

2

Research Site

Irvine, California, United States, 92618

Withdrawn

3

Research Site

North Haven, Connecticut, United States, 06473

Actively Recruiting

4

Research Site

Washington D.C., District of Columbia, United States, 20016

Actively Recruiting

5

Research Site

Coral Gables, Florida, United States, 33146

Not Yet Recruiting

6

Research Site

Chicago, Illinois, United States, 60637

Actively Recruiting

7

Research Site

Baltimore, Maryland, United States, 21224

Actively Recruiting

8

Research Site

Baltimore, Maryland, United States, 21231

Actively Recruiting

9

Research Site

Milford, Massachusetts, United States, 01757

Actively Recruiting

10

Research Site

Mineola, New York, United States, 11501

Actively Recruiting

11

Research Site

New York, New York, United States, 10016

Actively Recruiting

12

Research Site

New York, New York, United States, 10021

Actively Recruiting

13

Research Site

New York, New York, United States, 10029

Actively Recruiting

14

Research Site

Philadelphia, Pennsylvania, United States, 19104

Actively Recruiting

15

Research Site

Providence, Rhode Island, United States, 02903

Actively Recruiting

16

Research Site

Houston, Texas, United States, 77030

Actively Recruiting

17

Research Site

Fairfax, Virginia, United States, 22031

Actively Recruiting

18

Research Site

Kogarah, Australia, 2217

Actively Recruiting

19

Research Site

Melbourne, Australia, 3000

Actively Recruiting

20

Research Site

Edmonton, Alberta, Canada, T6G 1Z2

Actively Recruiting

21

Research Site

Toronto, Ontario, Canada, M5G 1X6

Actively Recruiting

22

Research Site

Beijing, China, 100142

Actively Recruiting

23

Research Site

Beijing, China, 100142

Not Yet Recruiting

24

Research Site

Chongqing, China, 400030

Actively Recruiting

25

Research Site

Guangzhou, China, 510100

Actively Recruiting

26

Research Site

Harbin, China, 150049

Not Yet Recruiting

27

Research Site

Wuhan, China, 430022

Actively Recruiting

28

Research Site

Marseille, France, 13385

Actively Recruiting

29

Research Site

Rennes, France, 35000

Actively Recruiting

30

Research Site

Villejuif, France, 94805

Actively Recruiting

31

Research Site

Milan, Italy, 20162

Actively Recruiting

32

Research Site

Orbassano, Italy, 10043

Actively Recruiting

33

Research Site

Rozzano, Italy, 20089

Actively Recruiting

34

Research Site

Verona, Italy, 37134

Actively Recruiting

35

Research Site

Chūōku, Japan, 104-0045

Actively Recruiting

36

Research Site

Kashiwa, Japan, 277-8577

Actively Recruiting

37

Research Site

Kōtoku, Japan, 135-8550

Actively Recruiting

38

Research Site

Osaka, Japan, 541-8567

Actively Recruiting

39

Research Site

Kuala Lumpur, Malaysia, 59100

Actively Recruiting

40

Research Site

Kuching, Malaysia, 93586

Actively Recruiting

41

Research Site

Seoul, South Korea, 03080

Actively Recruiting

42

Research Site

Seoul, South Korea, 03722

Actively Recruiting

43

Research Site

Seoul, South Korea, 05505

Actively Recruiting

44

Research Site

Seoul, South Korea, 06351

Actively Recruiting

45

Research Site

Barcelona, Spain, 8035

Actively Recruiting

46

Research Site

Madrid, Spain, 28040

Actively Recruiting

47

Research Site

Seville, Spain, 41013

Actively Recruiting

48

Research Site

Taichung, Taiwan, 40705

Actively Recruiting

49

Research Site

Taipei, Taiwan, 10002

Actively Recruiting

50

Research Site

Taipei, Taiwan, 11217

Actively Recruiting

51

Research Site

Taoyuan, Taiwan, 333

Actively Recruiting

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Research Team

A

AstraZeneca Clinical Study Information Center

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

3

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