Study name: A Phase I/II First-In-Human Clinical Trial to Evaluate the Safety, Tolerability and Anti-Tumor Activity of IMA402, a Bispecific T Cell-Engaging Receptor Molecule (TCER®) Targeting PRAME, as Monotherapy or in Combination With a Checkpoint Inhibitor in Patients With Recurrent and/or Refractory Solid Tumors
The goal of this clinical trial is to evaluate the safety, tolerability and anti-tumor activity of IMA402 in patients with recurrent and/or refractory solid tumors.
Primary objectives:
To determine the maximum tolerated doses and/or recommended doses for extensions for IMA402 as monotherapy and in combination with pembrolizumab (Phase Ia)
To characterize the safety and tolerability of IMA402 as monotherapy and in combination (Phase I/II)
To evaluate anti-tumor activity of IMA402 as monotherapy and in combination (Phase II)
Secondary objectives:
To evaluate the initial anti-tumor activity of IMA402 as monotherapy and in combination (Phase I)
To evaluate anti-tumor activity of IMA402 as monotherapy and in combination (Phase II)
To describe the PK of IMA402 as monotherapy and in combination (Phase I/II)
Intervention
DRUG: IMA402
IV infusions
DRUG: IMA402 and checkpoint inhibitor
IMA402 IV infusions and checkpoint inhibitor
DRUG: IMA402 and chemotherapy
IMA402 IV infusions and chemotherapy
DRUG: IMA402 and IMA401
IMA402 and IMA401 IV infusions
DRUG: IMA402 and monoclonal antibody
IMA402 IV infusions and monoclonal antibody
DRUG: IMA402 and chemotherapy +/- monoclonal antibody
IMA402 IV infusions and chemotherapy +/- monoclonal antibody
Key inclusion criteria
Patients ≥ 18 years old
Patients must have a specific pathologically confirmed and documented advanced and/or metastatic solid tumor indication
Patients must have received or not be eligible for indicated standard-of-care treatments per cohort
Measurable disease according to RECIST 1.1
Confirmed HLA status
ECOG Performance Status of 0 to 1
Adequate baseline hematologic, hepatic and renal function, acceptable coagulation status
Key exclusion criteria
Other active malignancies that require treatment or that might interfere with the trial endpoints
The patient is pregnant or is breastfeeding
History of hypersensitivity to components of IMA402 or rescue medications; hypersensitivity to or contraindication according to current SmPC for respective combination medicinal product
The patient has concurrent severe and/or uncontrolled medical disease. Any other health condition that would, in the investigator's or sponsor's judgement, contraindicate the patient's participation in the clinical trial because of safety concerns or compliance with clinical trial procedures
Patients with active brain metastases, history of bleeding into brain metastases, known brain metastases who are receiving therapeutic anticoagulation
Wij maken op deze website gebruik van cookies om het gebruik van de website te
vergemakkelijken, de prestaties en gebruikerservaring te verbeteren en de
relevantie van het aanbod op deze website te verhogen.
Lees ons Cookies &
Privacystatement.