This phase 1/2 first-in-human study is designed to test the safety and efficacy of IMC-R117C (PIWIL1 × CD3 ImmTAC® Bispecific Protein) as a single agent and in combination with other therapies in HLA-A\*02:01-positive participants with selected advanced PIWIL1-Positive cancers.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
600
St Vincent's Hospital
Darlinghurst, Sydney, Australia
ACTIVE_NOT_RECRUITINGPeter MacCallum Cancer Centre
Melbourne, Australia
RECRUITINGDose Escalation: Percentage of participants with ≥1 dose-limiting toxicity (DLT)
Time frame: Up to ~24 months
Dose Escalation: Percentage of participants with ≥1 adverse event (AE)
Time frame: Up to ~24 months
Dose Escalation: Percentage of participants with ≥1 serious adverse event (SAE)
Time frame: Up to ~24 months
Dose Escalation: Percentage of participants with significant changes in electrocardiogram (ECG) recordings
Time frame: Up to ~24 months
Dose Escalation: Percentage of participants with significant changes in vital signs
Time frame: Up to ~24 months
Dose Escalation: Percentage of participants with significant changes in laboratory results
Time frame: Up to ~24 months
Dose Escalation: Percentage of participants with a dose interruption, reduction, or discontinuation
Time frame: Up to ~24 months
Expansion: Best Overall Response (BOR) as Determined by RECIST v1.1
Time frame: Up to ~24 months
Dose Escalation: Best Overall Response (BOR) as Determined by RECIST v1.1 with IMC-R117C Monotherapy and in Combination
Time frame: Up to ~36 months
Dose Escalation: Duration of Response (DOR) as Determined by RECIST v1.1 with IMC-R117C Monotherapy and in Combination
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oral
IV infusion
IV infusion
Institut Jules Bordet
Anderlecht, Belgium
RECRUITINGUniversitair Ziekenhuis Gent
Ghent, Belgium
RECRUITINGUZ Leuven
Leuven, Belgium
RECRUITINGUniversitaetsklinikum Heidelberg
Heidelberg, Germany
RECRUITINGFondazione Policlinico Universitario Agostino Gemelli IRCCS
Roma, Italy
RECRUITINGnstituto Clinico Humanitas
Rozzano, Italy
RECRUITINGAntoni van Leeuwenhoek
Amsterdam, Netherlands
RECRUITINGHospital HM Nou Delfos
Barcelona, Spain
RECRUITING...and 3 more locations
Time frame: Up to ~36 months
Dose Escalation: Progression-free survival (PFS) as Determined by RECIST v1.1 with IMC-R117C Monotherapy and in Combination
Time frame: Up to ~36 months
Dose Escalation: Overall Survival (OS) with IMC-R117C Monotherapy and in Combination
Time frame: Up to ~36 months
Expansion: Duration of Response (DOR) as Determined by RECIST v1.1 with IMC-R117C Monotherapy
Time frame: Up to ~36 months
Expansion: Progression-free survival (PFS) as Determined by RECIST v1.1 with IMC-R117C Monotherapy
Time frame: Up to ~36 months
Expansion: Overall Survival (OS) with IMC-R117C Monotherapy
Time frame: Up to ~36 months
Expansion: Percentage of participants with ≥1 Adverse Events (AE)
Time frame: Up to ~24 months
Expansion: Percentage of participants with ≥1 Serious Adverse Events (SAE)
Time frame: Up to ~24 months
Expansion: Percentage of participants with significant changes in electrocardiogram (ECG) recordings
Time frame: Up to ~24 months
Expansion: Percentage of participants with significant changes in vital signs
Time frame: Up to ~24 months
Expansion: Percentage of participants with significant changes in laboratory findings
Time frame: Up to ~24 months
Expansion: Percentage of participants with dose interruptions, reductions, or discontinuation
Time frame: Up to ~24 months
All Study: Plasma Concentration of IMC-R117C
Time frame: Up to ~36 months
All Study: Incidence of anti-IMC-R117C Antibody Formation
Time frame: Up to ~36 months
All Study: Incidence of tumor expression and localization of PIWIL1
Time frame: Up to ~36 months