IMA402 T Cell-Engaging Receptor Molecule (TCER®) in Recurrent and/or Refractory Solid Tumors
- Conditions
- Recurrent CancerCancerRefractory CancerSolid Tumor, Adult
- Interventions
- Biological: IMA402 (Phase Ia)Biological: IMA402 (Phase Ib)Biological: IMA402 (Phase II)
- Registration Number
- NCT05958121
- Lead Sponsor
- Immatics Biotechnologies GmbH
- Brief Summary
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 dose and/or recommended dose for extension for IMA402 (Phase I)
* To characterize the safety and tolerability of IMA402 (Phase I/II)
* To evaluate anti-tumor activity of IMA402 (Phase II)
Secondary objectives:
* To evaluate the initial anti-tumor activity of IMA402 (Phase I)
* To evaluate anti-tumor activity of IMA402 (Phase II)
* To describe the PK of IMA402 (Phase I/II)
- Detailed Description
The study will be conducted in two phases:
* Phase Ia: Dose escalation/de-escalation
* Phase Ib: Dose extension
* Phase II: Dose extension in selected Indication-specific extension cohort(s) (ISEC)
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 145
- 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 all available indicated standard-of-care treatments
- 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
- Other active malignancies that require treatment or that might interfere with the trial endpoints (ongoing adjuvant anti-hormonal treatment is allowed)
- The patient is pregnant or is breastfeeding
- History of hypersensitivity to components of IMA402 or rescue medications, if no alternative treatment option is available
- The patient has concurrent severe and/or uncontrolled medical disease. Any other health condition that would, in the investigator'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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Dose escalation/de-escalation (Phase Ia) IMA402 (Phase Ia) Dose-Finding of IMA402 (Phase Ia) Dose extension (Phase Ib) IMA402 (Phase Ib) IMA402 monotherapy extension cohorts based on maximum tolerated dose (MTD) and/or recommended doses for extensions (RDEs) (Phase Ib) Dose extension (Phase II) IMA402 (Phase II) Selected ISEC investigated on MTD/RDEs based on a manageable/favorable safety profile and initial signs of anti-tumor activity (Phase II)
- Primary Outcome Measures
Name Time Method Phase I: Number of patients with dose limiting toxicities (DLTs) 24 months Phase I/II: Number of patients with serious TEAEs 40 months Phase I/II: Frequency of dose interruptions and reductions, permanent discontinuations 40 months Phase I/II: Number of patients with treatment-emergent adverse events (TEAEs) 40 months Phase I/II: Duration of dose interruptions and reductions, permanent discontinuations 40 months Phase II: Overall response rate (ORR) based on best overall response (BOR) of complete response (CR) and partial response (PR) locally assessed using Response Evaluation Criteria in Solid Tumors v1.1 (RECIST v1.1) 40 months
- Secondary Outcome Measures
Name Time Method Phase I/II: Determination of PK parameter: minimal serum concentration (Cmin) 40 months Phase I/II: Disease control rate (DCR) of CR, PR or stable disease (SD) (lasting 6 or more weeks) following the initiation of IMA402 based on RECIST v1.1 and iRECIST 40 months Phase I: ORR based on BOR of CR and PR locally assessed using RECIST v1.1 and iRECIST 37 months Phase II: ORR based on BOR of CR and PR locally assessed using iRECIST 40 months Phase I/II: Determination of PK parameter: half-life (t1/2) 40 months Phase I/II: Determination of PK parameter: area under the curve (AUC) 40 months Phase I/II: Determination of PK parameter: maximal serum concentration (Cmax) 40 months Phase I/II: Duration of response (DOR) of CR or PR based on RECIST v1.1 and iRECIST 40 months Phase I/II: Progression-free survival (PFS) based on RECIST v1.1 and iRECIST 40 months Phase I/II: Overall survival (OS) 40 months
Trial Locations
- Locations (20)
KEM I Evang. Kliniken Essen-Mitte gGmbH
🇩🇪Essen, North Rhine-Westphalia, Germany
Universitaetsklinikum Essen AöR
🇩🇪Essen, North Rhine-Westphalia, Germany
Johannes Wesling Klinikum Minden
🇩🇪Minden, North Rhine-Westphalia, Germany
Universitaetsklinikum Magdeburg AöR
🇩🇪Magdeburg, Saxony-Anhalt, Germany
Klinikum Chemnitz gGmbH
🇩🇪Chemnitz, Saxony, Germany
Universitaetsklinikum Carl Gustav Carus Dresden an der Technischen Universitaet Dresden AöR
🇩🇪Dresden, Saxony, Germany
Universitaetsklinikum Heidelberg AöR
🇩🇪Heidelberg, Baden-Wuerttemberg, Germany
Universitaetsklinikum Mannheim GmbH
🇩🇪Mannheim, Baden-Wuerttemberg, Germany
Universitaetsklinikum Ulm AöR
🇩🇪Ulm, Baden-Wuerttemberg, Germany
Universitaetsklinikum Erlangen AöR
🇩🇪Erlangen, Bavaria, Germany
Klinikum Nürnberg
🇩🇪Nuremberg, Bavaria, Germany
Universitaetsklinikum Regensburg
🇩🇪Regensburg, Bavaria, Germany
Universitaetsklinikum Wuerzburg AöR
🇩🇪Wuerzburg, Bavaria, Germany
Universitaetsklinikum Bonn AöR
🇩🇪Bonn, North Rhine-Westphalia, Germany
Marien Hospital Duesseldorf GmbH
🇩🇪Duesseldorf, North Rhine-Westphalia, Germany
University Of Leipzig
🇩🇪Leipzig, Saxony, Germany
Antoni von Leeuwenhoek- Netherlands Cancer Institute
🇳🇱Amsterdam, North Holland, Netherlands
Leiden Universitair Medisch Centrum
🇳🇱Leiden, South Holland, Netherlands
Universitair Medisch Centrum Groningen
🇳🇱Groningen, Netherlands
Universitair Medisch Centrum Utrecht
🇳🇱Utrecht, Netherlands