Study design
toxicity, tumor, Tumors
DISEASE, SECONDARY, TUMORS, TUMOR
This was a phase I, multicenter, open-label, dose-escalation and dose-expansion study (NCT02503774). The primary objectives were to assess safety and tolerability, describe any dose-limiting toxicity (DLT), and determine the maximum tolerated dose (MTD) of oleclumab alone and with durvalumab. Key secondary objectives were to determine the pharmacokinetics (PK) of oleclumab alone and with durvalumab; to determine immunogenicity in terms of the percentage of patients developing antidrug antibodies (ADAs); to evaluate candidate pharmacodynamic biomarkers in tumor tissue via assessment of target expression; and to describe preliminary antitumor activity in terms of objective response (OR) and disease control (DC) rates based on Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 [