Corbus Pharmaceuticals announced that an abstract for its first-in-human dose-escalation clinical study of CRB-701 (SYS6002) for advanced solid tumors has been released. The study, conducted in the US and Europe, evaluates the safety, pharmacokinetics, and efficacy of CRB-701 in patients with high Nectin-4 expression. Updated data from 38 patients will be presented at the 2025 American Society of Clinical Oncology Genitourinary Cancers Symposium (ASCO GU).
The upcoming data presentation at ASCO GU offers a crucial glimpse into the early clinical progress of CRB-701, a next-generation antibody-drug conjugate (ADC). This is particularly relevant for the oncology field, specifically for urothelial and other solid tumors expressing Nectin-4. Positive safety and efficacy signals at this stage could significantly de-risk further development and attract potential partnerships or investments. For patients, it represents potential progress toward new treatment options for these difficult-to-treat cancers.
The Phase 1 study is divided into three parts: dose escalation, dose optimization, and dose expansion. The initial dose escalation evaluated four dosages (1.8 mg/kg, 2.7 mg/kg, 3.6 mg/kg, and 4.5 mg/kg every three weeks). CRB-701 targets Nectin-4, a validated tumor-associated antigen in urothelial cancer, delivering a cytotoxic payload via a cleavable linker and a drug-antibody ratio of 2 using MMAE.
The data presented at ASCO GU will be critical in shaping the future development trajectory of CRB-701. Positive results could accelerate the progression into later-phase clinical trials, potentially leading to an accelerated approval pathway. This news highlights the potential of CRB-701 as a viable treatment option, offering hope for patients and marking a potential advancement in the oncology landscape.
Jon Napitupulu is Director of Media Relations at The Clinical Trial Vanguard. Jon, a computer data scientist, focuses on the latest clinical trial industry news and trends.