To observe the efficacy and safety of IMMU-132 in patients with advanced or recurrent ovarian cancer with high TROP-2 expression in tumor tissue, who have failed standard therapy or are unable to receive standard treatment.
Trophoblast cell surface antigen-2 (TROP-2) is overexpressed in a variety of epithelial-derived tumor tissues and represents a promising antitumor therapeutic target. Novel antibody-drug conjugates (ADCs) targeting TROP-2, such as IMMU-132 (SG), Datopotamab Deruxtecan (Dato-DXd), and Sacituzumab Tirumotecan (MK-2870), are under active development. In ovarian cancer, efficacy data for TROP-2 ADCs mainly derive from pan-solid tumor clinical studies. TROP-2 expression exhibits intratumoral heterogeneity. Currently, there is no standardized or internationally accepted guideline for evaluating TROP-2 expression. TROP-2 expression status can be assessed using the H-score scoring system: 0-100 as low expression, 100-200 as moderate expression, and \>200 as high expression. An exploratory analysis of the ASCENT study in triple-negative breast cancer, which categorized TROP-2 expression as high, moderate, or low based on H-score, found that patients with high expression had double the efficacy compared to those with moderate expression (44% vs 22%). Therefore, subsequent studies are warranted to explore effective screening criteria for TROP-2 ADC drugs to achieve more precise diagnosis and treatment. Our center has observed that among 3 patients with heavily pretreated recurrent ovarian cancer and high TROP-2 expression in tumor tissue, 1 achieved a complete response (CR) and 2 achieved partial responses (PR) following SG monotherapy. Safety was favorable, with main side effects being grade 1-2 gastrointestinal reactions and no grade 3-5 adverse reactions. Accordingly, this study will prospectively observe the efficacy of IMMU-132 monotherapy in patients with advanced or recurrent ovarian cancer characterized by high TROP-2 expression in tumor tissue.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
19
Sacituzumab govitecan monotherapy at a dose of 10 mg/kg administered intravenously on Days 1 and 8 of each 21-day cycle.
Zhongshan Hospital Fudan University
Shanghai, Shanghai Municipality, China
Objective response rate
The proportion of patients with complete response (CR) and partial response (PR) assessed by the investigator in accordance with the RECIST 1.1 criteria
Time frame: 12 months
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