Clinical TrialJun 1, 2026, 08:01 AM
NextCure SIM0505 Phase 1 shows 55% ORR in gynecologic cancers
AI Summary
NextCure, Inc. and Simcere Zaiming Pharmaceutical Co., Ltd. announced positive Phase 1 dose escalation data for SIM0505, an investigational antibody drug conjugate (ADC), at ASCO 2026. The study demonstrated a 55% objective response rate (ORR) in gynecologic cancers, including 52.9% in ovarian cancer and 66.7% in uterine serous carcinoma (USC), with a favorable safety profile. These results support the ongoing Phase 1 dose-optimization study, and NextCure plans to host a virtual KOL Event on June 2, 2026, to review the data.
Key Highlights
- SIM0505 Phase 1 data showed 55% objective response rate (ORR) in gynecologic cancers.
- ORR was 52.9% in ovarian cancer patients (9/17) and 66.7% in USC patients (2/3).
- Responses were observed within the therapeutic dose range (4.8 \u2013 8.0 mg/kg) at 12 weeks.
- The study demonstrated a favorable safety and tolerability profile in 59 heavily pretreated patients.
- NextCure will host a virtual Key Opinion Leader (KOL) Event on June 2, 2026, at 8 AM ET.
- SIM0505 has received USFDA Fast Track Designation for platinum-resistant ovarian cancer (PROC).