Phase 1 Study of RP-6306 With Carboplatin and Paclitaxel in TP53 Ovarian and Uterine Cancer

This is a phase 1 study to evaluate investigational drug RP-6306 in combination with carboplatin and paclitaxel in patients with TP53 mutated ovarian or uterine cancer. The dose escalation part of the study will determine the maximum tolerated dose (MTD) and recommended Phase 2 Dose (RP2D) and schedule of RP-6306 in combination with carboplatin and paclitaxel and the dose expansion will further assess the safety and tolerability as well as determine the preliminary efficacy of RP-6306 in combination with carboplatin and paclitaxel.

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 \