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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
184
phase 1 (dose finding) and phase 2 (dose expansion)
City of Hope
Duarte, California, United States
RECRUITINGCedars Sinai
Los Angeles, California, United States
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)
Time frame: From time of informed consent through treatment period and including the follow-up: up to 22 months
Objective Response Rate (ORR)
To investigate any preliminary antitumor activity
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: From time of informed consent through treatment period and including the follow-up: up to 22 months
Incidence of antidrug antibodies (ADA) against IPH6501
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Siteman Cancer Center
St Louis, Missouri, United States
RECRUITINGIcahn School Of Medicine At Mount Sinai
New York, New York, United States
ACTIVE_NOT_RECRUITINGMemorial Sloan Kettering Cancer Center
New York, New York, United States
RECRUITINGWollongong Private Hospital
Wollongong, New South Wales, Australia
RECRUITINGMonash Health
Clayton, Victoria, Australia
RECRUITINGPeninsula Private Hospital
Frankston, Victoria, Australia
RECRUITINGAustin Health
Heidelberg, Australia
RECRUITINGInstitute Bergonie
Bordeaux, France
RECRUITING...and 4 more locations
To evaluate the immunogenicity of IPH6501
Time frame: From time of informed consent through treatment period and including the follow-up: up to 22 months