1. A phase I study of IMC-001, a PD-L1 blocker, in patients with metastatic or locally advanced solid tumors
- Author
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Bhumsuk, Keam, Chan-Young, Ock, Tae Min, Kim, Do-Youn, Oh, Won Ki, Kang, Yeon Hee, Park, Jeeyun, Lee, Ji Hye, Lee, Yoen Hee, Ahn, Hyeon Ju, Kim, Sook Kyung, Chang, Jihyun, Park, Ji Yea, Choi, Yun Jeong, Song, and Young Suk, Park
- Subjects
Adult ,Male ,Dose-Response Relationship, Drug ,Maximum Tolerated Dose ,Antineoplastic Agents ,Middle Aged ,Antibodies, Monoclonal, Humanized ,B7-H1 Antigen ,Area Under Curve ,Neoplasms ,Humans ,Female ,Neoplasm Metastasis ,Aged - Abstract
Introduction IMC-001 is a fully human IgG1 monoclonal antibody that binds to human PD-L1 (programmed death-ligand 1). This study evaluated the safety, pharmacokinetics, and pharmacodynamics of IMC-001 in patients with advanced solid tumors. Materials and Methods This open-labeled phase I study used a standard 3 + 3 dose-escalation design, with doses ranging from 2 to 20 mg/kg. IMC-001 was administered intravenously every 2 weeks until disease progression or unacceptable toxicity. The dose-limiting toxicity window was defined as 21 days from the first dose. Results Fifteen subjects were included in 5 dose-escalation cohorts. No dose-limiting toxicity was observed, and the maximum tolerated dose was not reached. The most common adverse events (AEs) were general weakness, decreased appetite, fever, and cough. No grade 4 or 5 treatment emergent AEs were reported during the study. One subject in the 2 mg/kg cohort showed grade 2 immune-induced thyroiditis and diabetes mellitus suspected to be related to IMC-001. Over the dose range of 2-20 mg/kg IMC-001, the AUC
- Published
- 2021