A Study Investigating DNA-damage Response Agents in Molecularly Altered Advanced Cancer

Completed · Phase 2

Conditions studied: Advanced Solid Tumours

In brief

The study is investigating efficacy, safety and tolerability of DNA-damage Response Agents (or Combinations), in participants with advanced/metastatic solid malignancies whose tumours contain molecular alterations

Key facts

Study ID

NCT04564027

Run by

AstraZeneca

People needed

54

Starts

2020-12-01

Expected to finish

2025-02-18

Last updated by the study team

2025-08-29

Who can join

Age: 18 and older, up to 130. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Participants must have a histologically confirmed diagnosis of AST (excluding NSCLC) or mCRPC tumour.
• Participants must have a deleterious or suspected deleterious ATM mutation in tumour or blood (germline or ctDNA). Definitions of qualifying ATM mutations may include deleterious/suspected deleterious, pathogenic/likely pathogenic, disease- or cancer-associated variants, or equivalent wording. Variants of unknown significance, benign or likely benign alterations are not qualifying.
• Participant must have normal organ and bone marrow function measured within 28 days prior to the first dose of study intervention.
• Participants who have no curative treatment options and are deemed appropriate for an investigational study in the opinion of the investigator.
• Availability of archival or fresh tumour specimens for central testing of ATM protein loss using immunohistochemistry and for confirmation of ATM mutation using next generation sequencing.
• Previously received and progressed on at least one novel hormonal agent (eg, abiraterone acetate, apalutamide, and/or enzalutamide) for the treatment of prostate cancer
• Participants with histologically confirmed metastatic castrate resistant prostate cancer.
• Documented prostate cancer progression at study entry while on androgen deprivation or after bilateral orchiectomy as assessed by the investigator.
• Serum testosterone levels ≤ 50 ng/dL (≤ 1.75 nmol/L) within (≤) 28 days before enrolment.

You may not qualify if…

• Any of the following cardiac diseases currently or within the last 6 months:
• Unstable angina pectoris.
• Congestive heart failure > Class 2 as defined by the New York Heart Association
• Acute myocardial infarction.
• Significant ventricular or supraventricular arrhythmias.
• Mean resting corrected QT interval (QTc) > 470 msec obtained from three electrocardiograms (ECGs) in 24 hours using the Fredericia formula.
• Any factors that increase the risk of QTc prolongation or risk of arrhythmic events such as heart failure, hypokalaemia, congenital long QT syndrome, immediate family history of long QT syndrome or unexplained sudden death under 40 years of age.
• For Cohort B (mCRPC]), surgery or local prostatic intervention (excluding a prostatic biopsy) within 28 days of Cycle 1 Day 1.
• Participants with known active infections ((i.e., hepatitis B or C, tuberculosis, or COVID-19).
• Participants considered a poor medical risk due to a serious, uncontrolled medical disorder, non-malignant systemic disease or active, uncontrolled infection.
• Participants with symptomatic and/or uncontrolled brain metastases.
• Previous therapy with an telangiectasia and rad3 related protein inhibitor.
• Exposure to a small molecule investigational product within 14 days or 5 half-lives.
• Concomitant use of known strong CYP 3A inhibitors and inducers.

Where it is running

• Research Site — Duarte, California, United States
• Research Site — Los Angeles, California, United States
• Research Site — San Francisco, California, United States
• Research Site — Tampa, Florida, United States
• Research Site — Indianapolis, Indiana, United States
• Research Site — Baltimore, Maryland, United States
• Research Site — Ann Arbor, Michigan, United States
• Research Site — Las Vegas, Nevada, United States
• Research Site — New York, New York, United States
• Research Site — Ephrata, Pennsylvania, United States
• Research Site — Philadelphia, Pennsylvania, United States
• Research Site — Myrtle Beach, South Carolina, United States
• Research Site — Bordeaux, France
• Research Site — Dijon, France
• Research Site — Lyon, France
• Research Site — Vandœuvre-lès-Nancy, France
• Research Site — Barcelona, Spain
• Research Site — Madrid, Spain

Full record on ClinicalTrials.gov

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