공시 • Jun 02
NextCure, Inc. Presents Positive SIM0505 Phase 1 Dose Escalation Data In Patients With Gynecologic Cancers At ASCO
NextCure presented positive Phase 1 dose escalation data for SIM0505 at the American Society for Clinical Oncology (ASCO 2026) in Chicago, IL (poster #246). SIM0505 is an investigational antibody drug conjugate (ADC) targeting Cadherin-6 (CDH6) with a proprietary topoisomerase 1 inhibitor (TOPOi) payload. Platinum-resistant ovarian cancer (PROC) and uterine serous carcinoma (USC) represent two of the most challenging gynecologic malignancies. The Phase 1 dose escalation study (NCT06792552) evaluated SIM0505 in 59 heavily pre-treated cancer patients, with a data cutoff of April 07, 2026. Patients in the U.S. (n=25) and China (n=34) received SIM0505 at doses ranging from 1.6 mg/kg to 9.6 mg/kg, regardless of CDH6 expression. Positive efficacy data were observed, with an objective response rate (ORR) of: 55% (11/20) for gynecologic cancers (ovarian cancer and USC), 52.9% (9/17) for ovarian cancer, 66.7% (2/3) for USC. Responses were observed across a range of CDH6 expression. ORRs, above, are reported for patients within therapeutic dose cohorts of 4.8 – 8.0 mg/kg who had a minimum 12 weeks of follow-up at the data cut-off, and were determined by best response according to RECIST 1.1 criteria. Of the nine (9) ovarian patients with partial response (PR), there was one unconfirmed PR and one PR pending confirmation at next follow-up scan. ASCO Poster Overview: “Phase 1, multicenter, first-in-human (FIH) global study of SIM0505, an anti-CDH6 (CDH6) antibody-drug-conjugate (ADC) in patients with advanced solid tumors”. Table 1: Study Subject Overview: Baseline Characteristics: All Patients (n=59), Age, years: median (range) 58 (42-78), Sex, %: Male/Female 3.4%/96.6%, Race, n (%): Asian 34 (57.6%), Black or African American 3 (5.1%), White 20 (33.9%), Other 2 (3.4%), Tumor Type, n (%): Ovarian 46 (78.0%), USC/other endometrial 10 (16.9%), Renal cell carcinoma (RCC) 3 (5.1%), ECOG performance status, n (%): 0 16 (27.1%), 1 43 (72.9%), Prior systemic anti-cancer regimen: median (range) 5 (1-12). Table 2: Efficacy Overview: Patient Group ORR All gynecologic patients (n=20) 55% (11/20), Ovarian cancer (n=17) 52.9% (9/17), USC (n=3) 66.7% (2/3). Reported for patients within therapeutic SIM0505 dose cohorts of 4.8 – 8.0 mg/kg who had a minimum 12 weeks of follow-up at the April 7, 2026 data cut-off, and were determined by best response according to RECIST 1.1 criteria. Of the nine (9) ovarian patients with PR, there was one unconfirmed PR and one PR pending confirmation at next follow-up scan. Overall safety: Favorable overall data, potentially manageable in routine practice setting (n=59): Grade 1 and 2 treatment emergent adverse events (TEAEs) predominantly hematological, nausea and vomiting. Grade 3 and 4 TEAEs predominantly hematological and manageable without primary prophylaxis for hematological toxicities. Treatment related adverse events (TRAEs) requiring dose discontinuation: n=3. A full copy of the poster will be available on the NextCure website under the Investor Relations “Events & Presentations” tab following the presentation. SIM0505 is a novel ADC directed to CDH6, featuring a proprietary TOPOi payload. The ADC is designed for broad anti-tumor activity, fast systemic clearance and an improved potential therapeutic window. SIM0505 is being evaluated in an open-label, Phase 1 study (NCT06792552) for the potential treatment of advanced solid tumors, including ovarian cancer, with an emphasis on PROC. The U.S. Food and Drug Administration granted Fast Track Designation to SIM0505 for the treatment of PROC. NextCure holds exclusive global rights for SIM0505, excluding China, Hong Kong, Macau, and Taiwan which are retained by Simcere Zaiming. SIM0505 is being evaluated in a global Phase 1 open-label, multicenter study (NCT06792552) with sites in the U.S. and China. The Phase 1 dose escalation segment has evaluated SIM0505, at dose levels from 1.6 mg/kg to 9.6 mg/kg, in heavily pre-treated cancer patients with solid tumors including gynecologic cancers and renal cell carcinoma. As of the April 7, 2026 data cutoff, 59 patients were enrolled without preselection for CDH6 expression. Follow-up is ongoing. In May 2026, NextCure initiated a Phase 1 dose optimization segment in gynecologic cancers, initially focusing on patients with PR OC. The global study is expected to enroll up to 120 patients, with initial doses of 5.6, 6.4 and 7.2 mg/kg, at sites in the U.S., Canada, the EU and China.