Corbus Commences U.S. Phase 1 Trial with First Patient Dosed for Next-Gen Nectin-4 ADC CRB-701

Corbus Pharmaceuticals, a precision oncology firm, has initiated a Phase 1 clinical trial in the U.S. for CRB-701 (SYS6002), an innovative antibody-drug conjugate (ADC) that targets Nectin-4, a protein overexpressed in certain cancers. The trial is designed to assess the safety, efficacy, and pharmacokinetics of CRB-701 in patients with advanced solid tumors characterized by high Nectin-4 expression. The study will begin with dose escalation, proceed to dose optimization, and culminate in dose expansion to establish the dosage for Phase 2 trials.
The trial's commencement follows positive preliminary data from a Phase 1 study conducted by CSPC Pharmaceutical Group in China, suggesting that CRB-701 may offer a distinct pharmacokinetic and safety profile compared to PADCEV® (enfortumab vedotin-ejfv), a currently approved Nectin-4 ADC for metastatic urothelial cancer. The potential benefits of CRB-701 are particularly relevant for patients with metastatic urothelial cancer and other Nectin-4 positive tumors.
CRB-701 is equipped with a site-specific, cleavable linker and a uniform drug-to-antibody ratio of 2, utilizing monomethyl auristatin E (MMAE) as its cytotoxic payload. Nectin-4 is a well-established tumor-associated antigen in urothelial cancer, and PADCEV® has recently been expanded for use in combination with KEYTRUDA® for patients who are not candidates for cisplatin-based chemotherapy.
Corbus Pharmaceuticals, headquartered in Norwood, Massachusetts, is dedicated to advancing innovative scientific methods to combat serious illnesses through a diverse portfolio. Their pipeline includes CRB-701, CRB-601, an anti-integrin monoclonal antibody targeting TGFβ on cancer cells, and CRB-913, a CB1 inverse agonist for obesity treatment.

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