Safety and Tolerability of IPH4502 in Patients With Advanced Solid Tumors
ConditionAdvanced or Metastatic Solid Tumors
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorInnate Pharma
About this trial
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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Histologically confirmed, unresectable, locally advanced or metastatic solid tumors that are known to express Nectin-4
Prior systemic treatment for locally advanced or metastatic disease, yet no therapy with demonstrated clinical benefit for the tumor type is available.
Measurable disease according to RECIST 1.1.
Archival tumor tissue obtained within 4 months of screening and since the last anticancer therapy prior to the study or agree to undergo a tumor biopsy at baseline.
Disqualifiers
Known or suspected brain metastases.
Participants with an active infection, Any other infection requiring systemic treatment or latent infection.
Participants with clinically significant comorbidity(s).
History of treatment for, or suspicion or confirmed interstitial lung disease (ILD) at baseline.
Trial design
Design model
Single group
Treatments tested in this trial
IPH4502
DrugPart 1 (dose escalation) and Part 2 (dose optimization)
Treatment groups
145 Participants
are divided into 1 treatment groupGroup A: IPH4502 MonotherapyExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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 monthsSecondary outcomes
1
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 months2
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 months3
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 months4
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 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov