IMA402 T Cell-Engaging Receptor Molecule (TCER®) in Recurrent and/or Refractory Solid Tumors
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorImmatics Biotechnologies GmbH
About this trial
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)
Eligibility criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- IMA402
- IMA402 and checkpoint inhibitor
- IMA402 and chemotherapy
- IMA402 and IMA401
- IMA402 and monoclonal antibody
- IMA402 and chemotherapy +/- monoclonal antibody
Treatment groups
400 Participants
are divided into 3 treatment groupsLocations
29Germany
Thoraxklinik Heidelberg gGmbH69126, HeidelbergBaden-Wurttemberg, Germany
Universitaetsklinikum Heidelberg AöR69120, HeidelbergBaden-Wurttemberg, Germany
Universitaetsklinikum Mannheim GmbH68167, MannheimBaden-Wurttemberg, Germany
Universitaetsklinikum Tuebingen AöR72076, TübingenBaden-Wurttemberg, Germany
Sponsors and collaborators
Immatics Biotechnologies GmbH
Lead sponsor
Source ClinicalTrials.gov