Phase 1 First-in-human study of the safety and efficacy of IMC-P115C as a single agent and in combination with standard of care (SOC) agents in participants with advanced PRAME positive cancers. IMC-P115C is a half-life extended (HLE) ImmTAC targeting PRAME.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
140
IV infusion
Cancer Research South Australia (CRSA)
Adelaide, Australia
RECRUITINGLinear Clinical Research ltd.
Nedlands, Australia
Percentage of participants with dose-limiting toxicities (DLT)
Time frame: Up to ~16 months
Percentage of participants with adverse events (AE)
Time frame: Up to ~16 months
Percentage of participants with serious adverse events (SAE)
Time frame: Up to ~16 months
Percentage of participants with a dose interruption, reduction, or discontinuation
Percentage of participants with dosing changes or discontinuations.
Time frame: Up to ~16 months
Best Overall Response (BOR) as determined by RECIST v1.1 per the Investigator.
Time frame: Up to ~19 months
Duration of Response (DOR) as determined by RECIST v1.1 per the Investigator.
Time frame: Up to ~19 months
Progression Free Survival (PFS) as determined by RECIST v1.1 per the Investigator.
Time frame: Up to ~19 months
Overall Survival (OS)
OS is the time from first dose of study therapy until death due to any cause.
Time frame: Up to ~19 months
Change from baseline in lymphocyte counts
Change from baseline in lymphocyte counts
Time frame: Up to ~19 months
Changes in serum cytokine concentrations
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Melanoma Institute Australia
Wollstonecraft, Australia
RECRUITINGUNICANCER - Centre Leon-Berard (CLB)
Lyon, France
RECRUITINGCentre Hospitalier Universitaire (CHU) de Toulouse-Institut Universitaire du Cancer de Toulouse-Oncopole (IUCT-Oncopole)
Toulouse, France
RECRUITINGInstitut Gustave Roussy
Villejuif, France
RECRUITINGFondazione IRCCS - Istituto Nazionale dei Tumori
Milan, Italy
RECRUITINGIstituto Europeo di Oncologia
Milan, Italy
RECRUITINGIstituto Nazionale Tumori IRCCS Fondazione "G. Pascale"
Napoli, Italy
RECRUITINGHospital Universitari Vall d Hebron
Barcelona, Spain
RECRUITING...and 3 more locations
Change from baseline in serum cytokine concentrations
Time frame: Up to ~19 months
IMC-P115C Plasma Concentration
IMC-P115C plasma concentration
Time frame: Up to ~19 months
Percentage of participants with anti-IMC-P115C antibody formation
Time frame: Up to ~19 months