Spots Global Cancer Trial Database for A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of CN1
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Trial Identification
Brief Title: A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of CN1
Official Title: A Phase I, Open Label, Multi-Center, Dose Escalation Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of CN1 in Patients With Advanced Solid Tumors or B-cell Lymphoma
Study ID: NCT04418141
Interventions
Study Description
Brief Summary: This study is the first-in-human clinical trial of CN1 to evaluate the safety, tolerability, pharmacokinetic (PK) profile and preliminary efficacy of CN1 in patients with advanced solid tumors or B-cell lymphoma. This study will provide a basis for further clinical development of CN1.
Detailed Description: CN1 could promote T cell activation and cytokine secretion, thereby enhancing the function of CD4+ and CD8+ T cells, and could also regulate Treg cells, thus CN1 is considered to enhance the anti-tumor immune response and have potential antitumor activity. In this multicenter, open-label, dose-escalation Phase I study six dose levels are planned. Participants will receive CN1 by IV infusion on Day 1 of each cycle (every 3 weeks). After completion of treatment cycles, the participant will be assessed by the Principal Investigator and/or Safety Monitoring Committee (SMC).
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Mater Medical Centre, Brisbane, Queensland, Austria
Contact Details
Name: John Park
Affiliation: Macquarie University Hospital
Role: PRINCIPAL_INVESTIGATOR
Name: Jim Coward
Affiliation: Icon Cancer Centre (Brisbane)
Role: PRINCIPAL_INVESTIGATOR
Name: Daniel Brungs
Affiliation: Illawarra Cancer Care Centre (Wollongong)
Role: PRINCIPAL_INVESTIGATOR
Name: Gary Richardson
Affiliation: Cabrini Hospital (Melbourne)
Role: PRINCIPAL_INVESTIGATOR
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