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)
Iksuda Therapeutics Ltd.
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).
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
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Males or females, ≥ 18 years of age 2. Part 1: documented B cell NHL (any subtype except Burkitt lymphoma, Waldenström macroglobulinemia, chronic lymphocytic leukemia); previously confirmed CD19-positive if feasible 3. Part 2: documented B cell NHL (subtypes to be determined); confirmed CD19-positive; possible expansion cohorts may include: 1. Diffuse large B cell lymphoma (including germinal center B cell type, activated B cell type) 2. Follicular lymphoma (including duodenal-type follicular lymphoma) 3. Mantle cell lymphoma 4. B cell lymphomas not specifi…
Interventions
- DrugIKS03
IKS03 is a human monoclonal antibody (Ab) targeting CD19 linked to a pyrrolobenzodiazepine (PBD) pro-drug as the cytotoxic agent.
Locations (13)
- University of Maryland BaltimoreBaltimore, Maryland
- Westmead HospitalWestmead, New South Wales
- Royal Adelaide HospitalAdelaide, South Australia
- Royal Hobart HospitalHobart, Tasmania
- Linear Clinical ResearchPerth, Western Australia
- Jewish General HospitalMontreal, Quebec