Coherent Biopharma completed phase I clinical trial of CBP-1018, the world’s first dual-ligand conjugate drug targeting PSMA and FRα, in China

CBP-1018 is the first dual-ligand conjugate drug targeting PSMA and FRα developed on Coherent Biopharma (CBP)’s Bi-XDC technology platform. Recently, CBP announced that the company has successfully achieved its goals of CBP-1018 Phase I clinical trial in China.

PSMA is a highly promising anti-tumor drug target, with many diagnostic and therapeutic drugs targeting this target currently under development. Nearly half of them are still in Phase I clinical trials, with PSMA theragnostics being the most common type and advancing at the fastest pace.

Preclinical study results of CBP-1018 have shown good anti-tumor effects on various solid tumors such as prostate cancer, renal cell carcinoma, lung adenocarcinoma, and squamous cell carcinoma. CBP-1018 has the advantages such as higher target specificity, greater stability in human plasma, better solubility, and faster clearance.

The Phase I clinical trial evaluated the safety, tolerability, pharmacokinetic characteristics, and preliminary efficacy of CBP-1018 in patients with advanced malignant solid tumors. The dose escalation part of the trial from 0.03 mg/kg to 0.14 mg/kg dose has been successfully completed with 20 patients enrolled, including 18 with prostate cancer, and bladder cancer, urothelial carcinoma. Notably, adverse events related to CBP-1018 treatment were manageable, and no DLT events were observed in any of the dose groups. Among the prostate cancer patients who are still in the trial, the longest treatment duration has reached 12.6 months. In the 0.10 mg/kg dose group, one patient’s PSA level decreased by more than 50%, while another patient’s PSA level decreased by over 90%. In the 0.14 mg/kg dose group, PR was achieved in one prostate cancer patient with evaluable lesions, and target lesions reduced by 41%.

Given the excellent results of the Phase Ia dose escalation trial, the Phase Ib clinical expansion trial is initiated and will continue to explore additional treatment doses and further clarify the clinical characteristics and potential applications of CBP-1018. 

CBP would like to express special thanks to the patients and their family members for their participation in this clinical trial, and to the Investigators from Sun Yat-sen Memorial Hospital of Sun Yat-sen University and Tianjin Medical University Cancer Institute and Hospital for their strong support for the Phase I trial of CBP-1018 in China!