Trials / Recruiting
RecruitingNCT05365659
IKS03 in Patients With Advanced B Cell Non-Hodgkin Lymphomas
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)
- Status
- Recruiting
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 140 (estimated)
- Sponsor
- Iksuda Therapeutics Ltd. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
- B-cell Non-Hodgkin Lymphoma
- Diffuse Large B Cell Lymphoma
- Follicular Lymphoma
- Mantle Cell Lymphoma
- B-cell Lymphoma
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | IKS03 | IKS03 is a human monoclonal antibody (Ab) targeting CD19 linked to a pyrrolobenzodiazepine (PBD) pro-drug as the cytotoxic agent. |
Timeline
- Start date
- 2023-09-05
- Primary completion
- 2026-09-01
- Completion
- 2028-09-01
- First posted
- 2022-05-09
- Last updated
- 2025-10-01
Locations
13 sites across 5 countries: United States, Australia, Canada, Italy, Spain
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT05365659. Inclusion in this directory is not an endorsement.