Clinical outcomes of ethnically and racially diverse patients with gynecologic malignancies in phase I clinical trials at a single institution (2021–2024).

e17544 Background: Phase I clinical trials offer a treatment for patients with gynecologic malignancies that have progressed past standard of care treatments, yet there is limited current data on the clinical outcomes of patients enrolled in these trials. This retrospective study evaluates the survival, clinical benefit rate, and toxicity profile of patients with gynecologic malignancies enrolled in Phase I clinical trial drugs at a single institution from February 2021 to November 2024. Methods: A retrospective chart review was conducted on patients with pathologically confirmed gynecologic malignancy who enrolled in Phase I clinical trials at a single institution during the study period. Data collected included demographics, disease characteristics, overall survival (OS), progression-free survival (PFS), clinical benefit rate (CBR), and drug-related toxicities. OS and PFS were measured from the date of Phase I enrollment. CBR was defined as complete response, partial response, or stable disease based on the RECIST criteria. Toxicity was measured using NCI CTCAE, with dose-limiting toxicity defined as Grade 3 or 4. Results: The analysis included 22 patients, consisting of 15 with ovarian histology and 7 with endometrial/uterine histology. The study population was racially and ethnically diverse, with a majority of participants (59%) identifying as members of underrepresented groups, including 36% Black and 23% Hispanic individuals. The median age at the time of enrollment was 67. The median overall survival (OS) was 57 weeks range: 7.1 - 124 weeks, and the median progression-free survival (PFS) was 8 weeks range: 3.3 - 101 weeks. The clinical benefit rate was 40.9%, with 31.8% of all patients achieving stable disease ≥ 4 months. No patients met criteria for partial response or complete response. Grades 3 or 4 hematologic drug-related toxicities occurred in 9.1% of patients. Conclusions: The findings provide contemporary data on outcomes for patients with gynecologic malignancy enrolled in Phase I clinical trials at our institution. The results suggest these drugs could be an avenue for patients who have exhausted existing methods of management for their advanced or recurrent cancers. Further work should continue to monitor the outcomes of patients on Phase I trials for gynecologic malignancies, which will help inform patient counseling and highlight the ongoing necessity for novel and effective agents in this patient population.