This is a first-in-human, open-label, multicenter, Phase 1 study to evaluate the safety, tolerability and preliminary efficacy of IPH4502 and to determine the recommended Phase 2 dose (RP2D) in advanced solid tumors that are known to express Nectin-4
This is a first-in-human, open-label, multicenter, single-arm Phase 1 study, with a part 1 dose escalation guided by a Bayesian optimal interval design with backfilling (BOIN-BF), followed by a part 2 dose optimization in up to 2 selected indications. This study is to measure the safety, tolerability, pharmacokinetics, and preliminary efficacy of escalating doses of IPH4502 in patients with advanced solid tumors that are known to express Nectin-4.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
145
Part 1 (dose escalation) and Part 2 (dose optimization)
Massachusetts General Hospital - Boston
Boston, Massachusetts, United States
RECRUITINGJohn Theurer Cancer Center
Hackensack, New Jersey, United States
RECRUITINGMount Sinai Tisch Cancer Center
New York, New York, United States
Safety and Tolerability
To evaluate the incidence of AEs, SAEs, TEAEs, and DLTs.
Time frame: From time of first dose through treatment period, including the follow-up: up to 24 months
Maximum Observed Plasma Concentration (Cmax)
To characterize and evaluate the pharmacokinetic profile of IPH4502.
Time frame: From time of informed consent through treatment period, including the follow-up: up to 24 months
Area Under the Plasma Concentration (AUC)
To characterize and evaluate the pharmacokinetic profile of IPH4502.
Time frame: From time of informed consent through treatment period, including the follow-up: up to 24 months
Incidence of antidrug antibodies (ADA) against IPH4502
To evaluate the immunogenicity of IPH4502.
Time frame: From time of informed consent through treatment period, including the follow-up: up to 24 months
Objective Response Rate (ORR)
To investigate any preliminary antitumor activity of IPH4502.
Time frame: From time of informed consent through treatment period, including the follow-up: up to 24 months
Duration Of Response (DoR)
To investigate any preliminary antitumor activity of IPH4502.
Time frame: From time of informed consent through treatment period, including the follow-up: up to 24 months
Progression Free Survival (PFS)
To investigate any preliminary antitumor activity of IPH4502.
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NEXT Oncology - Dallas
Dallas, Texas, United States
RECRUITINGNEXT Oncology - Virginia
Fairfax, Virginia, United States
RECRUITINGCentre Léon Bérard
Lyon, France
RECRUITINGGustave Roussy Cancer Institute
Villejuif, France
RECRUITINGTime frame: From time of informed consent through treatment period, including the follow-up: up to 24 months