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.
Participants must have a histologically confirmed diagnosis of AST (excluding NSCLC) or mCRPC tumor.
Participants must have a deleterious ATM mutation in tumor 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. Testing must be performed in a locally accredited laboratory using a validated test in line with local regulations (eg, CAP/CLIA laboratory where available). Submission of a copy of local test result is mandatory for eligibility.
Participants must submit a FFPE sample for central confirmation of ATM IHC and NGS status.
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 tumor 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 enrollment.
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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