Ligachem Biosciences Announces First Patient Enrollment in Phase 1b Trial of CS5001 (ROR1-ADC, LCB71)
Ligachem Biosciences announced on November 20 that the first patient has been enrolled in the Phase 1b clinical trial of CS5001 (ROR1-ADC, LCB71), a drug licensed to CStone Pharmaceuticals.
During the Phase 1a dose-escalation study, CS5001 demonstrated excellent tolerability across ten dose levels, with no dose-limiting toxicities observed. The study included patients with B-cell lymphoma and solid tumors, showcasing its promising safety profile.
At the recommended Phase 2 dose of DL8 (125 μg/kg), CS5001 achieved a 76.9% objective response rate (ORR) in advanced B-cell lymphoma patients, including four cases of complete remission (CR) and six cases of partial remission (PR). Among Hodgkin lymphoma patients, the drug achieved a 100% ORR, with two CRs and one PR. Additionally, CS5001 demonstrated efficacy in advanced solid tumors such as non-small cell lung cancer (NSCLC) and pancreatic cancer.
A Ligachem representative stated, "The Phase 1b trial focuses on dose optimization and expansion. It will provide crucial data to support a pivotal Phase 2 trial targeting relapsed and refractory diffuse large B-cell lymphoma patients."
CS5001 is emerging as a potential breakthrough in the field of Antibody-Drug Conjugates with applications across various hematologic malignancies and solid tumors. The ongoing Phase 1b trial is expected to solidify its potential for regulatory approval and commercialization.