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).
Males or females, ≥ 18 years of age
Part I: documented B cell NHL (any subtype except Burkitt lymphoma, Waldenström macroglobulinemia, chronic lymphocytic leukemia); previously confirmed CD19-positive if feasible
Diffuse large B cell lymphoma (including germinal center B cell type, activated B cell type)
Follicular lymphoma (including duodenal-type follicular lymphoma)
Women who are pregnant or intending to become pregnant before, during, or within 8 months after the last dose of study drug; women who are breastfeeding
Patients documented to be CD19-negative
Central nervous system (CNS) lymphoma, leptomeningeal infiltration, or spinal cord compression not controlled by prior surgery or radiotherapy; symptoms suggesting CNS involvement
Treated, non-melanoma skin cancers
Sequential
IKS03
DrugIKS03 is a human monoclonal antibody (Ab) targeting CD19 linked to a pyrrolobenzodiazepine (PBD) pro-drug as the cytotoxic agent.
Recommended Phase 2 Dose (Part I)
RP2D will be determined using dose limiting toxicities (DLTs) and all other available study data
Objective Response Rate (Part II)
Antineoplastic effects will be assessed by Criteria for Response Assessment: The Lugano Classification (Cheson 2014)
Evaluation of the immunogenicity of IKS03 (Part I and II)
Occurrence of ADA measured in serum at selected timepoints during the study
Plasma Concentrations of IKS03 (Part I and II)
Pharmacokinetic profile will be characterized by concentrations of IKS03
Determine recommended Phase 2 dose (RP2D) (Part II)
Based on evidence of antitumor activity, acceptable tolerability, evidence of achieving target plasma concentration
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