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
Location: See all (13) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
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).

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
United States
Maryland
University of Maryland Baltimore
WITHDRAWN
Baltimore
Other Locations
Australia
Royal Adelaide Hospital
RECRUITING
Adelaide
Royal Hobart Hospital
RECRUITING
Hobart
Linear Clinical Research
RECRUITING
Perth
Westmead Hospital
RECRUITING
Westmead
Canada
Jewish General Hospital
RECRUITING
Montreal
Italy
La Fondazione e l'Istituto di Candiolo
RECRUITING
Candiolo
Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) Ospedale San Raffaele
RECRUITING
Milan
Istituto Europeo Clinico Humanitas
RECRUITING
Milan
Istituto Europeo di Oncologia
RECRUITING
Milan
Spain
Institut Catala D'Oncologia
RECRUITING
Badalona
Hospital Universitario Quironsalud Madrid
RECRUITING
Madrid
Hospital Clinico Universitario de Salamanca
RECRUITING
Salamanca
Contact Information
Primary
David Browning
david.browning@iksuda.com
615-975-7776
Time Frame
Start Date: 2023-09-05
Estimated Completion Date: 2028-09
Participants
Target number of participants: 140
Treatments
Experimental: Dose Escalation Cohort (Part 1)
Each patient will receive repeat doses (by intravenous (IV) infusions) on Day 1 of each 21-day cycle. Participants may continue on study until disease progression, unacceptable toxicity, or other withdrawal criteria is met.
Experimental: Dose Expansion: Diffuse-Large B-Cell Lymphoma Participants
Each patient will receive IKS03 at the recommended dose for expansion (RDE) defined in Part 1 on Day 1 of each 21-day cycle. Participants may continue on study until disease progression, unacceptable toxicity, or other withdrawal criteria is met.
Experimental: Dose Expansion: Follicular Cell Lymphoma Participants
Each patient will receive IKS03 at the recommended dose for expansion (RDE) defined in Part 1 on Day 1 of each 21-day cycle. Participants may continue on study until disease progression, unacceptable toxicity, or other withdrawal criteria is met.
Experimental: Dose Expansion: Mantle Cell Lymphoma Participants
Each patient will receive IKS03 at the recommended dose for expansion (RDE) defined in Part 1 on Day 1 of each 21-day cycle. Participants may continue on study until disease progression, unacceptable toxicity, or other withdrawal criteria is met.
Experimental: Dose Expansion: Other B cell lymphoma (B-NHL not otherwise specified [NOS])
Each patient will receive IKS03 at the recommended dose for expansion (RDE) defined in Part 1 on Day 1 of each 21-day cycle. Participants may continue on study until disease progression, unacceptable toxicity, or other withdrawal criteria is met.
Sponsors
Leads: Iksuda Therapeutics Ltd.

This content was sourced from clinicaltrials.gov