PDS Biotechnology (PDSB) announced patient recruitment has been completed in Stage 1 of a clinical trial of the company’s PDS01ADC therapeutic administered systemically in combination with floxuridine, or FUDR, administered by hepatic artery infusion pump, or HAIP, for patients with metastatic colorectal cancer, led by the National Cancer Institute, a component of the National Institutes of Health (NIH). The study met the pre-set RECIST v1.1 criteria for expansion into Stage 2 of the study. A Simon two-stage trial design is being used for each cohort. For the colorectal cancer cohort, if at least 6 of 9 participants experienced an objective response by RECIST v1.1 criteria, the cohort would continue to enroll up to a total of 22 participants. This milestone has been achieved for the colorectal cancer cohort, and enrollment has progressed to Stage 2. The cholangiocarcinoma and adrenocortical cancer cohorts continue to enroll in Stage 1. PDS Biotech anticipates completion of patient recruitment for the metastatic colorectal cancer cohort of the study by Q4.
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