Spots Global Cancer Trial Database for IKS03 in Patients With Advanced B Cell Non-Hodgkin Lymphomas
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Trial Identification
Brief Title: IKS03 in Patients With Advanced B Cell Non-Hodgkin Lymphomas
Official Title: A Phase 1 Cohort Dose Escalation and Expansion Trial to Determine the Safety, Tolerance, Maximum Tolerated Dose, and Preliminary Antineoplastic Activity of IKS03 in Patients With Advanced B Cell Non-Hodgkin Lymphomas (NHL)
Study ID: NCT05365659
Interventions
Study Description
Brief Summary: This first-in-human study will evaluate the recommended dose for further clinical development, safety, tolerability, antineoplastic activity, immunogenicity, pharmacokinetics and pharmacodynamics of IKS03, a CD19 targeting antibody-drug conjugate, in patients with advanced B cell non-Hodgkin lymphoma (NHL).
Detailed Description: The study will consist of 2 parts: dose-escalation (Part 1) and dose-expansion (Part 2). The dose-escalation part (Part 1) of the study is to evaluate the safety and tolerability of increasing dose levels of IKS03 to establish a recommended dose for expansion (RDE); and the dose-expansion part (Part 2) of the study is to further evaluate the safety, pharmacokinetics/pharmacodynamics, and efficacy of IKS03 at the RDE.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
University of Maryland Baltimore, Baltimore, Maryland, United States
Linear Clinical Research, Perth, Western Australia, Australia
Jewish General Hospital, Montréal, Quebec, Canada
Contact Details
Name: Paul I Nadler, MD
Affiliation: Iksuda Therapeutics
Role: STUDY_DIRECTOR
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