Actively Recruiting

Phase 1
Phase 2
Age: 18Years - 130Years
All Genders
NCT05417594

Study of AZD9574 as Monotherapy and in Combination With Anti-cancer Agents in Participants With Advanced Solid Malignancies

Led by AstraZeneca · Updated on 2026-05-05

695

Participants Needed

32

Research Sites

276 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

This study will assess the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary efficacy of AZD9574 individually and in combination with anti-cancer agents in participants with advanced cancer that has recurred/progressed.

CONDITIONS

Official Title

Study of AZD9574 as Monotherapy and in Combination With Anti-cancer Agents in Participants With Advanced Solid Malignancies

Who Can Participate

Age: 18Years - 130Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Eastern Cooperative Oncology Group performance status (ECOG PS) with no worsening in the past 2 weeks
  • Progressive cancer at enrollment
  • Adequate organ and marrow function
  • Specific gene mutation in BRCA1, BRCA2, PALB2, RAD51C, or RAD51D depending on module
  • Evaluable disease measurable by imaging
  • Suitable for treatment with PARP inhibitors or temozolomide as applicable
  • Ability to eat high fat meal and follow fasting restrictions
  • Female participants of childbearing potential must have negative pregnancy tests and use effective contraception
  • Male participants must use condoms with spermicide and avoid fathering a child during and for months after treatment
  • Provided tumor samples for testing as required
  • ECOG performance status of 0 or 1
  • Consent to tumor biopsies for pharmacodynamics evaluation if applicable
Not Eligible

You will not qualify if you...

  • Major surgery within 4 weeks before first treatment dose
  • Recent radiotherapy within 2 to 4 weeks before treatment
  • Unresolved toxicities from prior therapy above grade 1 except alopecia
  • Severe or uncontrolled systemic diseases including infections with hepatitis B, C, or HIV
  • Uncontrolled seizures or history of severe brain injury or stroke
  • Myelodysplastic syndrome or acute myeloid leukemia
  • Significant gastrointestinal conditions affecting drug absorption
  • Allergy to study drugs or excipients
  • Contraindications to MRI or unstable corticosteroid use before baseline MRI
  • Concurrent anti-cancer therapies or prohibited medications
  • Previous extensive therapy with PARP inhibitors or alkylating chemotherapy as specified per module
  • Certain blood clotting or neurological conditions
  • BMI over 30 kg/m2 or body weight over 100 kg for PET sub-study
  • Use of immunosuppressive medication or corticosteroids above certain doses before treatment
  • History of other primary malignancies or severe lung diseases
  • Pregnant or breastfeeding participants or those planning pregnancy

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 32 locations

1

Research Site

La Jolla, California, United States, 92093

Withdrawn

2

Research Site

Los Angeles, California, United States, 90095

Actively Recruiting

3

Research Site

San Francisco, California, United States, 94143

Actively Recruiting

4

Research Site

Chicago, Illinois, United States, 60611

Actively Recruiting

5

Research Site

Boston, Massachusetts, United States, 02215

Actively Recruiting

6

Research Site

New York, New York, United States, 10040

Actively Recruiting

7

Research Site

New York, New York, United States, 10065

Actively Recruiting

8

Research Site

Portland, Oregon, United States, 97239

Completed

9

Research Site

Houston, Texas, United States, 77030

Actively Recruiting

10

Research Site

San Antonio, Texas, United States, 78229

Not Yet Recruiting

11

Research Site

Richmond, Virginia, United States, 23298

Withdrawn

12

Research Site

Darlinghurst, Australia, 2010

Actively Recruiting

13

Research Site

Melbourne, Australia, 3000

Actively Recruiting

14

Research Site

Randwick, Australia, 2031

Actively Recruiting

15

Research Site

Bayern, Germany, 80337

Withdrawn

16

Research Site

Berlin, Germany, 13353

Withdrawn

17

Research Site

Heidelberg, Germany, 69120

Withdrawn

18

Research Site

Mainz, Germany, 55131

Withdrawn

19

Research Site

Seoul, South Korea, 03080

Actively Recruiting

20

Research Site

Seoul, South Korea, 03722

Actively Recruiting

21

Research Site

Seoul, South Korea, 06351

Actively Recruiting

22

Research Site

A Coruña, Spain, 15006

Actively Recruiting

23

Research Site

Barcelona, Spain, 8035

Actively Recruiting

24

Research Site

Málaga, Spain, 29010

Actively Recruiting

25

Research Site

Pozuelo de Alarcón, Spain, 28223

Actively Recruiting

26

Research Site

Sant Cugat del Vallès, Spain, 08195

Actively Recruiting

27

Research Site

Seville, Spain, 41013

Actively Recruiting

28

Research Site

Lund, Sweden, 22185

Actively Recruiting

29

Research Site

Stockholm, Sweden, 118 83

Actively Recruiting

30

Research Site

Glasgow, Scotland, United Kingdom, G12 0YN

Actively Recruiting

31

Research Site

London, United Kingdom, EC1M 6BQ

Actively Recruiting

32

Research Site

Newcastle upon Tyne, United Kingdom, NE7 7DN

Actively Recruiting

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Research Team

A

AstraZeneca Clinical Study Information Center

CONTACT

A

AstraZeneca Breast Cancer Study Locator Service

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

SEQUENTIAL

Primary Purpose

TREATMENT

Number of Arms

9

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