A Modular Phase 2a Multicentre Open-Label Study to Investigate DNA-damage Response Agents (or Combinations) in Patients With Advanced Cancer Whose Tumours Contain Molecular Alterations (PLANETTE)
The study is investigating efficacy, safety and tolerability of DNA-damage Response Agents (or Combinations), in participants with advanced/metastatic solid malignancies whose tumour contain molecular alterations.
1. To obtain a preliminary assessment of the efficacy of study intervention as
assessed by response rate. 2. To obtain a preliminary assessment of
further efficacy endpoints with study intervention. 3. To assess the safety and tolerability profile of study intervention.
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 uncontrolled brain metastases.
Previous therapy with 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.
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