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Title: A Phase I, First-in-Human Study of PRL3-zumab in Advanced, Refractory Solid Tumors and Hematological Malignancies
Authors: Chee, Cheng E 
Ooi, Melissa 
Lee, Soo-Chin 
Sundar, Raghav 
Heong, Valerie
Yong, Wei-Peng 
Ng, Chin Hin 
Wong, Andrea
Lim, Joline SJ 
Tan, David SP 
Soo, Ross 
Tan, Joshua TC
Yang, Song
Thura, Min
Al-Aidaroos, Abdul Qader
Chng, Wee Joo 
Zeng, Qi 
Goh, Boon-Cher 
Keywords: Science & Technology
Life Sciences & Biomedicine
Issue Date: 15-Apr-2023
Publisher: SPRINGER
Citation: Chee, Cheng E, Ooi, Melissa, Lee, Soo-Chin, Sundar, Raghav, Heong, Valerie, Yong, Wei-Peng, Ng, Chin Hin, Wong, Andrea, Lim, Joline SJ, Tan, David SP, Soo, Ross, Tan, Joshua TC, Yang, Song, Thura, Min, Al-Aidaroos, Abdul Qader, Chng, Wee Joo, Zeng, Qi, Goh, Boon-Cher (2023-04-15). A Phase I, First-in-Human Study of PRL3-zumab in Advanced, Refractory Solid Tumors and Hematological Malignancies. TARGETED ONCOLOGY. ScholarBank@NUS Repository.
Abstract: Background: Phosphatase of regenerating liver-3 (PRL-3) is involved in cellular processes driving metastasis, cell proliferation, invasion, motility and survival. It has been shown to be upregulated and overexpressed in cancer tissue, in contrast to low or no expression in most normal tissue. PRL3-zumab is a first-in-class humanized antibody that specifically binds to PRL-3 oncotarget with high affinity and has been shown to reduce tumor growth and increase survival. Objective: In the study, we aimed to determine the safety and efficacy of PRL3-zumab in patients with advanced solid tumors and hematological malignancies. Methods: We conducted a phase I, first-in-human study in advanced solid tumors and hematological malignancies to investigate the safety, tolerability and efficacy of PRL3-zumab. Response rates were evaluated using the Response Evaluation Criteria in Solid Tumors (RECIST) guideline (version 1.1) for solid tumors. For acute myeloid leukemia (AML) patients, bone marrow response criteria based on the European Leukaemia Network (ELN) 2017 guidelines for AML were used. We also explored the pharmacokinetics and pharmacodynamic relationships of PRL3-zumab in patients. This study was registered with NCT03191682. Results: In the dose-escalation cohort, 11 patients with advanced solid tumors were enrolled into the study. An additional 12 patients with solid tumors and four patients with AML were enrolled in the dose-expansion cohort. Maximum tolerability was not achieved in this study, as there were no dose-limiting toxicities. Potential treatment-emergent adverse events were grade 1 increased stoma output and fatigue and grade 2 vomiting. Best response observed was stable disease in three solid-tumor patients (11.1%). The pharmacokinetics of PRL3-zumab were dose proportional, consistent with an IgG type monoclonal antibody. Conclusions: PRL3-zumab, a first-in-class humanized antibody, was safe and tolerable in solid tumors and hematological malignancies.
ISSN: 1776-2596
DOI: 10.1007/s11523-023-00962-w
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