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Phase I study of imalumab (BAX69), a fully human recombinant antioxidized macrophage migration inhibitory factor antibody in advanced solid tumours
- Source :
- British Journal of Clinical Pharmacology
- Publication Year :
- 2020
- Publisher :
- Wiley, 2020.
-
Abstract
- Aim Preclinical evidence suggests that oxidized macrophage migration inhibitory factor (oxMIF) may be involved in carcinogenesis. This phase 1 study (NCT01765790) assessed the safety, tolerability, pharmacokinetics and antitumour activity of imalumab, an oxMIF inhibitor, in patients with advanced cancer using '3 + 3' dose escalation. Methods In Schedule 1, patients with solid tumours received doses from 1 to 50 mg/kg IV every 2 weeks. In Schedule 2, patients with metastatic colorectal adenocarcinoma, non-small-cell lung, or ovarian cancer received weekly doses of 10 or 25 mg/kg IV (1 cycle = 28 days). Treatment continued until disease progression, unacceptable toxicity, dose-limiting toxicity, or withdrawal of consent. Results Fifty of 68 enrolled patients received imalumab. The most common treatment-related adverse events (TRAEs) included fatigue (10%) and vomiting (6%); four grade 3 serious TRAEs (two patients) occurred. The dose-limiting toxicity was allergic alveolitis (one patient, 50 mg/kg every 2 weeks). The maximum tolerated and biologically active doses were 37.5 mg/kg every 2 weeks and 10 mg/kg weekly, respectively. Of 39 assessed patients, 13 had stable disease (≥4 months in 8 patients). Conclusions Imalumab had a maximum tolerated dose of 37.5 mg/kg every 2 weeks in patients with advanced solid tumours, with a biologically active dose of 10 mg/kg weekly. Further investigation will help define the role of oxMIF as a cancer treatment target.
- Subjects :
- Male
medicine.medical_specialty
Lung Neoplasms
Maximum Tolerated Dose
Antineoplastic Agents
030226 pharmacology & pharmacy
Gastroenterology
03 medical and health sciences
0302 clinical medicine
Pharmacokinetics
Carcinoma, Non-Small-Cell Lung
Neoplasms
Internal medicine
Humans
Medicine
Pharmacology (medical)
030212 general & internal medicine
Adverse effect
Macrophage Migration-Inhibitory Factors
Pharmacology
clinical trials
business.industry
Antibodies, Monoclonal
Original Articles
phase I
medicine.disease
Clinical trial
Treatment Outcome
Tolerability
Toxicity
Vomiting
Female
Original Article
Macrophage migration inhibitory factor
medicine.symptom
business
Ovarian cancer
pharmacokinetics
Subjects
Details
- ISSN :
- 13652125 and 03065251
- Volume :
- 86
- Database :
- OpenAIRE
- Journal :
- British Journal of Clinical Pharmacology
- Accession number :
- edsair.doi.dedup.....207d838854cf282e84922849ed00035f