RT023 / Shanghai Ruotuo Biotechnology - LARVOL DELTA

A Study of RT023 in Patients With Advanced Solid Tumors (clinicaltrials.gov) - P1/2 | N=318 | Not yet recruiting | Sponsor: Shanghai Ruotuo Biosciences Co., Ltd.

New P1/2 trial • Oncology • Solid Tumor

Acquisition of a gene cluster in Clostridioides difficile PCR ribotype 023 strains enables xylitol utilization. (PubMed, mSphere) - "Recently, there has been an increase in infections caused by PCR ribotype 023 (RT023) strains in Europe...This xylitol utilization ability confers a fitness benefit in competition against other C. difficile ribotypes, as well as in a fecal community in vitro. Research investigating the underlying genetic factors driving the physiology of C. difficile will improve our understanding of colonization and hypervirulence."

Journal • Infectious Disease

RT023, a first-in-class CEACAM5/EGFR targeted bispecific antibody drug conjugate (ADC) in colorectal cancer (CRC) (AACR 2026) - "EGFR antibodies like cetuximab are standard first-line therapy for colorectal cancer (CRC) patients with wild-type KRAS, but are less effective in those with KRAS mutations, creating an unmet clinical need. ADCs targeting CEACAM5 or EGFR, such as M9140 and MRG003, are under clinical development for CRC; however, single-target ADCs have shown limited efficacy, likely due to variable antigen expression among patients... RT023, with its unique bispecific design and differentiated features in affinity, linker-payload, has shown promising potential as a first-in-class ADC candidate for CRC treatment. Preclinical discovery studies have revealed favorable efficacy and toxicity profiles, supporting advancing RT023 into first-in-human studies."

ADC • Bispecific • First-in-human • Colorectal Cancer • Oncology • Solid Tumor • CEACAM5 • KRAS