期刊
INTERNATIONAL JOURNAL OF CANCER
卷 149, 期 6, 页码 1313-1321出版社
WILEY
DOI: 10.1002/ijc.33695
关键词
CIGB-552; COMMD1; NF-kappa B; phase I; solid tumors
类别
资金
- Ministry of Public Health of Cuba
- CIGB
CIGB-552 is a synthetic peptide that upregulates COMMD1 protein levels, showing clinical benefits in patients with advanced tumors. The maximum tolerated dose was defined as 4.7 mg, with dose-limiting toxicity observed at 7.0 mg. Seven patients had significant changes in CD4/CD8 ratio in response to treatment.
CIGB-552 is a synthetic peptide that interacts with COMMD1 and upregulates its protein levels. The objectives of this phase I study were safety, pharmacokinetic profile, evaluation of the lymphocytes CD4+ and CD8+ and preliminary activity in patients with advanced tumors. A 3 + 3 dose-escalation design with seven dose levels was implemented. Patients were included until a grade 3 related adverse event occurred and the maximum tolerated dose was reached. The patients received subcutaneous administration of CIGB-552 three times per week for 2 weeks. Single-dose plasma pharmacokinetics was characterized at two dose levels, and tumor responses were classified by RECIST 1.1. Twenty-four patients received CIGB-552. Dose-limiting toxicity was associated with a transient grade 3 pruritic maculopapular rash at a dose of 7.0 mg. The maximum tolerated dose was defined as 4.7 mg. Ten patients were assessable for immunological status. Seven patients had significant changes in the ratio CD4/CD8 in response to CIGB-552 treatment; three patients did not modify the immunological status. Stable disease was observed in five patients, including two metastatic soft sarcomas. We conclude that CIGB-552 at dose 4.7 mg was well tolerated with no significant adverse events and appeared to provide some clinical benefits.
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