RecruitingPhase 1Phase 2NCT05417594

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

A Modular Phase I/IIa, Open-label, Multi-centre Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Preliminary Efficacy of Ascending Doses of AZD9574 as Monotherapy and in Combination With Anti-cancer Agents in Patients With Advanced Solid Malignancies (CERTIS1)

Sponsor

AstraZeneca

Enrollment

695 participants

Start Date

Jun 24, 2022

Study Type

INTERVENTIONAL

Conditions

Advanced Solid Malignancies

Summary

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.

Eligibility

Min Age: 18 YearsMax Age: 130 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new drug called AZD9574, which is a type of PARP inhibitor — a class of drugs that blocks a protein cancer cells use to repair their DNA. It is being tested alone and in combination with other cancer treatments in people with advanced solid tumors, with a focus on brain cancers and cancers with certain DNA repair gene mutations. **You may be eligible if...** - You have an advanced cancer that is still progressing despite prior treatment - You are in reasonably good physical condition (able to perform self-care and light activity) - Your organs (kidneys, liver, blood) are functioning adequately - You may have a cancer with a BRCA mutation or other DNA repair defect, or a brain tumor like glioblastoma **You may NOT be eligible if...** - You have had certain prior treatments that overlap with this study's drugs - You have uncontrolled brain metastases - You have significant heart problems or active infections - You are pregnant or breastfeeding - You have had a recent major surgery or stroke Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGAZD9574

Participants will receive AZD9574 orally.

DRUGTemozolomide (TMZ)

Participants will receive temozolomide orally.

DRUG[11C]AZ1419 3391

Participants will receive \[11C\]AZ1419 3391 intravenously.

DRUGTrastuzumab Deruxtecan (T-DXd)

Participants will receive T-DXd intravenously.

DRUGDatopotamab Deruxtecan (Dato-DXd)

Participants will receive Dato-DXd intravenously.

Locations(33)

Research Site

La Jolla, California, United States

Research Site

Los Angeles, California, United States

Research Site

San Francisco, California, United States

Research Site

Chicago, Illinois, United States

Research Site

Boston, Massachusetts, United States

Research Site

New York, New York, United States

Research Site

New York, New York, United States

Research Site

Portland, Oregon, United States

Research Site

Houston, Texas, United States

Research Site

San Antonio, Texas, United States

Research Site

Richmond, Virginia, United States

Research Site

Camperdown, Australia

Research Site

Darlinghurst, Australia

Research Site

Melbourne, Australia

Research Site

Randwick, Australia

Research Site

Bayern, Germany

Research Site

Berlin, Germany

Research Site

Heidelberg, Germany

Research Site

Mainz, Germany

Research Site

Seoul, South Korea

Research Site

Seoul, South Korea

Research Site

Seoul, South Korea

Research Site

A Coruña, Spain

Research Site

Barcelona, Spain

Research Site

Málaga, Spain

Research Site

Pozuelo de Alarcón, Spain

Research Site

Sant Cugat del Vallès, Spain

Research Site

Seville, Spain

Research Site

Lund, Sweden

Research Site

Stockholm, Sweden

Research Site

Glasgow, Scotland, United Kingdom

Research Site

London, United Kingdom

Research Site

Newcastle upon Tyne, United Kingdom

View Full Details on ClinicalTrials.gov

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NCT05417594

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