CRB-701 (SYS6002) is an investigational antibody-drug conjugate (ADC) targeting Nectin-4, a protein overexpressed in various cancers, including prostate cancer. CRB-701 is designed to deliver a cytotoxic payload directly to Nectin-4-expressing tumor cells, aiming to enhance efficacy while minimizing off-target effects.

The ongoing Phase 1/2 clinical trial (NCT06265727) is evaluating the safety, pharmacokinetics, and efficacy of CRB-701 in patients with advanced solid tumors known to express high levels of Nectin-4. The trial consists of three parts:

Preliminary results have been promising. At doses of 2.7 mg/kg or higher, CRB-701 demonstrated an overall response rate of 40% across various tumor types, with a disease control rate of 73%. Specifically, in metastatic urothelial cancer patients, the response rate was 44%, while in cervical cancer patients, it was 43%. The treatment was generally well-tolerated, with primarily grade 1/2 adverse effects and no grade 4/5 events reported.

In recognition of its potential, the U.S. Food and Drug Administration granted Fast Track designation to CRB-701 in December 2024 for the treatment of relapsed or refractory metastatic cervical cancer. This designation is intended to expedite the development and review of drugs addressing unmet medical needs.

Further data from the ongoing study is anticipated to be presented at the 2025 American Society of Clinical Oncology Genitourinary Cancers Symposium in February 2025. These developments underscore CRB-701’s potential as a targeted therapy for Nectin-4-positive cancers, offering hope for improved treatment options in this patient population.

Clinical trial.