Brief Summary
This first-in-human study will evaluate the recommended dosethe amount of medication taken for further clinical development, safety, tolerability, antineoplastic activity, immunogenicity, pharmacokinetics and pharmacodynamics of IKS03, a CD19 targeting antibody-drug conjugate, in patients with advancedat a late stage, far along B cell non-Hodgkin lymphomacancers of the lymphatic system (NHL).
Intervention / Treatment
- Drug: IKS03
Inclusion Criteria:
- Males or females, ≥ 18 years of age
- Part 1: documented B cell NHL (any subtype except Burkitt lymphoma, Waldenström macroglobulinemia, chronica long-lasting disease that changes slowly over time 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 marrowsoft, spongy tissue found in bones that makes blood cells involvement must be willing to undergo bone marrow biopsyremoval of a section of tissue to analyse for cancer cells 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: screeningtesting for cancer or conditions that can lead to cancer before symptoms appear, also known as cancer 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 consenta process in which a patient receives detailed information about a procedure or treatment, including its potential risks, benefits, and alternatives. The patient then has the opportunity to understand the information and voluntarily agree to the procedure or treatment..