Dr. Stephanie Lheureux
Inclusion Criteria:
- Written informed consent
- Females ≥18 years old at the time of signature of the consent form.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 within 28
days prior to enrollment.
- All patients must have histologically proven, locally advanced or metastatic
recurrent ovarian and uterine cancer. Patients will be eligible only if available
curative therapy does not exist.
- Ovarian and uterine cancer should be high-grade and TP53 abnormal by
immunohistochemistry or TP53 mutated by genomic profiling.
- Patients must be eligible for re-challenge carboplatin and paclitaxel.
- Patient must have archival tissue available for molecular profiling.
- Measurable disease as per Response Evaluation Criteria in Solid Tumours (RECIST)
v1.1 at the time of enrollment.
- Ability to comply with the protocol and study procedures.
- Acceptable study required organ function at screening
- Acceptable study required hematologic function at screening
- Negative pregnancy test (serum) for women of child-bearing potential (WOCBP) at
screening. WOCBP who are sexually active and their partners must agree to use a
highly effective form of contraception throughout their participation during the
study and for 6 months after the last dose of study treatment.
- Resolution of all toxicities of prior therapy or surgical procedures to baseline or
Grade 1 (except for neuropathy, hypothyroidism requiring medication, and alopecia,
which must have resolved to Grade ≤2).
- Any prior radiation must have been completed at least 7 days prior to the start of
study treatment, and patients must have recovered from any acute adverse effects
prior to the start of study treatment.
- Life expectancy ≥12 weeks after the start of the treatment according to the
Investigator's judgment.
Exclusion Criteria:
- Chemotherapy or small molecule antineoplastic agent given within 21 days or