2024 World Conference on Lung Cancer (WCLC) - Posters-P2.14B.03 A Phase II Parallel Arm Study of Sacituzumab Govitecan-Hziy in Patients with Advanced Thymoma and Thymic Carcinoma

P2.14B.03 A Phase II Parallel Arm Study of Sacituzumab Govitecan-Hziy in Patients with Advanced Thymoma and Thymic Carcinoma

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This study investigates the efficacy and safety of sacituzumab govitecan-hziy, a Trop-2-directed antibody-drug conjugate, in patients with advanced thymoma and thymic carcinoma. Thymic epithelial tumors (TETs), including thymoma and thymic carcinoma, are rare cancers for which treatment options are limited after initial platinum-based chemotherapy. Trop-2 is often overexpressed in these tumors, making sacituzumab govitecan-hziy a potentially effective treatment due to its success in other cancers, such as breast and urothelial carcinoma.<br /><br />The study is a Phase II, open-label, multicenter clinical trial featuring parallel cohorts. It targets patients with advanced thymoma (Cohort A) or thymic carcinoma (Cohort B) who have undergone at least one previous systemic therapy. Initial enrollment requires adequate performance status, measurable disease, and sufficient organ function, employing a Simon optimal two-stage design. Each cohort will initially enroll 9 patients. If at least one patient shows a positive response, it will expand to a total of 17 participants.<br /><br />Patients receive sacituzumab govitecan-hziy at 10 mg/kg on Days 1 and 8 of every 21-day cycle until disease progression or unacceptable toxicity occurs. Tumor response is assessed using the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1, with imaging every two cycles for the first three months and every three cycles thereafter. Secondary endpoints include the evaluation of adverse events, median and six-month progression-free survival, duration of response, and overall survival.<br /><br />This study is crucial as it addresses the lack of a standard treatment for TETs after first-line therapy fails, potentially offering a new therapeutic avenue for patients with advanced thymoma and thymic carcinoma.

Asset Subtitle

Jennifer Marks

Meta Tag

Speaker Jennifer Marks

Topic Mesothelioma, Thymoma & Other Thoracic Tumors

Keywords

sacituzumab govitecan-hziy

Trop-2-directed antibody-drug conjugate

advanced thymoma

thymic carcinoma

thymic epithelial tumors

Phase II clinical trial

Simon optimal two-stage design

RECIST v1.1

progression-free survival

treatment options