Share
Save
Phase1/2 Study of IPH6501 in Patients With Relapsed /Refractory B-Cell Non-Hodgkin Lymphoma
This is an international, first-in-human, multicenter, open-label Phase 1/2 study to evaluate the safety profile, tolerability of IPH6501, and determine the recommended phase 2 dose (RP2D) for patients with B-Cell non-Hodgkin lymphoma.
Study details:
In Phase 1 - Dose finding, patients with advanced histologically confirmed, documented CD20+ B-cell non-Hodgkin lymphoma (NHL) will be enrolled. The dose finding part will include 2 sub-parts: Dose escalation will determine the Maximum Tolerated Dose (MTD) or the highest tested dose, Dose assessment will determine RP2D. In Phase 2 - Dose expansion, one or more cohorts will be selected with patients with subtypes of advanced histologically confirmed, documented CD20+ B-cell non-Hodgkin lymphoma.
Eligibility criteria
Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.
Inclusion criteria
Exclusion criteria
Eligibility
Age eligible for study : 18 and older
Healthy volunteers accepted : No
Gender eligible for study: All
Things to know
Study dates
Study start: 2024-03-04
Primary completion: 2028-12-31
Study completion finish: 2028-12-31
Study type
TREATMENT
Phase
PHASE1
PHASE2
Trial ID
NCT06088654
Intervention or treatment
DRUG: IPH6501
Conditions
- • Non Hodgkin Lymphoma
Find a site
Closest Location:
Monash Health
Research sites nearby
Select from list below to view details:
Monash Health
Clayton, Victoria, Australia
Austin Health
Heidelberg, Not Specified, Australia
Wollongong Private Hospital
Wollongong, New South Wales, Australia
Peninsula Private Hospital
Frankston, Victoria, Australia
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
| Participant Group/Arm | Intervention/Treatment |
|---|---|
EXPERIMENTAL: IPH6501 monotherapy
| DRUG: IPH6501
|
What is the study measuring?
Primary outcome
| Primary Outcome Measure | Primary Outcome Description | Primary Outcome Time Frame |
|---|---|---|
| Safety and tolerability | To evaluate the safety profile (including dose limiting toxicities (DLT(s), the maximum tolerated dose (MTD) or highest tested dose), tolerability and determine the recommended phase 2 dose (RP2D) | From time of informed consent through treatment period and including the follow-up: up to 22 months |
Secondary outcome
| Secondary Outcome Measure | Secondary Outcome Description | Secondary Outcome Time Frame |
|---|---|---|
| Objective Response Rate (ORR) | To investigate any preliminary antitumor activity | From time of informed consent through treatment period and including the follow-up: up to 22 months |
| Duration Of Response (DoR) | To investigate any preliminary antitumor activity | From time of informed consent through treatment period and including the follow-up: up to 22 months |
| Progression Free Survival (PFS) | To investigate any preliminary antitumor activity | From time of informed consent through treatment period and including the follow-up: up to 22 months |
| Maximum Observed Plasma Concentration (Cmax) | To characterize and evaluate the pharmacokinetic profile of IPH6501 | From time of informed consent through treatment period and including the follow-up: up to 22 months |
| Area Under the Plasma Concentration (AUC) | To characterize and evaluate the pharmacokinetic profile of IPH6501 | From time of informed consent through treatment period and including the follow-up: up to 22 months |
| Incidence of antidrug antibodies (ADA) against IPH6501 | To evaluate the immunogenicity of IPH6501 | From time of informed consent through treatment period and including the follow-up: up to 22 months |
Frequently Asked Questions
Please note: some questions and answers are submitted by anonymous patients or using AI, and have not been verified by Clinrol
No questions submitted. Be the first to ask a question!