Radiance Biopharma has dosed the first patient in China for a Phase 1 clinical trial of RB-164™ (SYS6005), a next-generation antibody-drug conjugate (ADC) targeting ROR-1. This trial, conducted in partnership with CSPC Pharmaceutical Group, follows successful preclinical and non-human primate studies. The study will evaluate RB-164™’s safety, efficacy, and pharmacokinetics in patients with ROR-1 positive hematologic cancers and solid tumors in China, the U.S., Australia, and Europe.
This advancement marks a critical step in potentially addressing unmet medical needs for patients with ROR-1 positive cancers like Diffuse Large B-Cell Lymphoma. The initiation of the trial in China expands the patient pool and accelerates the drug’s development timeline. Furthermore, positive results could validate Radiance’s ADC technology platform and pave the way for further development of their pipeline, including the preclinical HER2/TROP2 Bispecific ADC, RB-201™.
RB-164™ utilizes several innovative features, including an Fc-silenced monoclonal antibody, a unique conjugation method to minimize payload loss, and site-specific conjugation for improved drug delivery. The drug has received IND clearance from both the Chinese NMPA and the U.S. FDA. The trial design includes dose escalation, followed by optimization and expansion phases, allowing for a thorough evaluation of the drug’s therapeutic window.
This first dosing in China sets the stage for valuable clinical data readout. Positive results from this trial could propel RB-164™ towards later-stage clinical development, potentially offering a new treatment option for patients with difficult-to-treat cancers. It also strengthens Radiance Biopharma’s position in the competitive ADC 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.
