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)
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 1: documented B cell NHL (any subtype except Burkitt lymphoma, Waldenström macroglobulinemia, chronic lymphocytic leukemia); previously confirmed CD19-positive if feasible
• Part 2: documented B cell NHL (subtypes to be determined); confirmed CD19-positive; possible expansion cohorts may include:
∙ Diffuse large B cell lymphoma (including germinal center B cell type, activated B cell type)
‣ Follicular lymphoma (including duodenal-type follicular lymphoma)
‣ Mantle cell lymphoma
‣ B cell lymphomas not specified
• If B cell NHL subtype likely to have bone marrow involvement must be willing to undergo bone marrow biopsy in the event of an on-study complete response to confirm response
• NHL that is relapsed, refractory to, or intolerant of existing therapy(ies) with known curative potential, or for which no standard therapy is available; must have received at least 2 prior lines of systemic therapy
• Must be in need of systemic treatment and not require immediate cytoreductive therapy
• Part 1: measurable or non-measurable disease
• Part 2: measurable disease according to The Revised Criteria/Lugano Classification
• Part 1: screening tumor biopsy requested, but optional; Part 2: patient must agree to screening tumor biopsy
⁃ ECOG performance status 0 or 1; anticipated life expectancy ≥ 10 weeks
⁃ Women of childbearing potential and fertile men agreeing to use two effective methods of contraception (including a highly effective method of contraception); women beginning 2 weeks prior to the first dose, men beginning prior to the first dose, and both continuing until 8 months after the last dose of study drug; male patients must also agree to refrain from sperm donation during this period.
⁃ Ability to understand and give written informed consent