The U.S. Food and Drug Administration (FDA) has accepted the AbGenomics International‘s Investigational New Drug Application or IND for AbGn-107, the company’s antibody-drug conjugate or ADC candidate for the treatment of pancreatic, gastric (stomach), and colorectal cancers. Based on the acceptance, the company will be initiating a Phase I proof of concept clinical trial (NCT02908451) for the treatment of patients with advanced gastrointestinal cancers.
“The commencement of this clinical trial will mark a significant milestone for AbGenomics,” noted Ron Lin, Ph.D., President and Chief Executive Officer of AbGenomics.
“We are pleased to have received FDA acceptance for our clinical trial protocol and look forward to evaluating the use of our own ADC product candidate for the treatment of solid tumors,” Lin added.
Phase I study
The Phase I dose escalation with cohort expansion clinical study will evaluate the safety, tolerability, pharmacokinetics, and preliminary efficacy of AbGn-107 therapy in patients with chemo-refractory, locally advanced, recurrent, or metastatic gastric, colorectal, or pancreatic cancer.
Researchers at AbGenomics expects to enroll approximately 54 patients in the study at multiple clinical sites across the country.