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
- Patients with advanced histologically confirmed, documented CD20+ B-cell non-Hodgkin's lymphoma (NHL) including the following types defined by WHO 2016: Diffuse Large B Cell Lymphoma (DLBCL); high grade; thymic; Follicular Lymphoma (FL); Mantle cell lymphoma (MCL); Marginal zone lymphoma (MZL)
- Relapsed, progressive and/or refractory disease without established alternative therapy
- Must have received at least 2 prior systemic therapies including at a minimum anti-CD20 antibody therapy (e.g., rituximab) potentially in combination with chemotherapy and/or relapsed after autologous stem cell rescue.
- Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2
- Adequate organ and hematological function
- Able to provide a fresh biopsy from a safely accessible site (or historical biopsy), per investigator determination.
Exclusion criteria
- Patients with another invasive malignancy in the last 2 years
- Prior chemotherapy, immunotherapy or other anti-cancer therapy within less than 4 weeks before study drug administration.
- Autologous stem cell transplant or treatment with CAR-T (Chimeric Antigen Receptor T-Cell) cell therapy within 100 days prior to first dose of study drug
- Subjects with brain or subdural metastases are not eligible, nor those with history of central nervous system (CNS) lymphoma
- Current or past history of CNS disease, such as stroke, epilepsy, CNS vasculitis, or neurodegenerative disease.
- Known history of infection with human immunodeficiency virus (HIV) or hepatitis B or C
- Major surgery within 4 weeks before the first dose of study drug
- Comorbidities including diabetes, cardiovascular diseases, immunodeficiencies/autoimmune condition
- Pregnant / breastfeeding woman
Eligibility
Age eligible for study : NA
Healthy volunteers accepted : No
Gender eligible for study: ALL
Things to know
Study dates
Study start:
Primary completion:
Study completion finish:
Study type
TREATMENT
Phase
- PHASE1PHASE2
Study ID
NCT06088654
Intervention or treatment
DRUG: IPH6501
Conditions
- Non Hodgkin Lymphoma
You may be eligible to participate in this trial based on your search. Check eligibility by answering some questions.
Research sites nearby
Closest Location:
Wollongong Private Hospital
Select from list below to view details:
Wollongong Private Hospital
Wollongong, New South Wales, Australia
Monash Health
Clayton, Victoria, Australia
Peninsula Private Hospital
Frankston, Victoria, Australia
Austin Health
Heidelberg, Australia
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Who is running the clinical trial?
Innate Pharma
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
| Measure | Description | 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
| Measure | Description | 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 |
References
Clinical Trials Gov: Phase1/2 Study of IPH6501 in Patients With Relapsed /Refractory B-Cell Non-Hodgkin LymphomaOther trials to consider
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