Clinical trial · Interventional
IMA402 T Cell-Engaging Receptor Molecule (TCER®) in Recurrent and/or Refractory Solid Tumors
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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)
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
| Recurrent Cancer | Malignant Neoplasm | CURATED_BROADER | 0.78 |
| Refractory Cancer | Malignant Neoplasm | CURATED_BROADER | 0.78 |
| Solid Tumor, Adult | Adult Solid Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (6)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| IMA402 | Drug | — | UNRESOLVED |
| IMA402 and checkpoint inhibitor | Drug | — | UNRESOLVED |
| IMA402 and chemotherapy | Drug | — | UNRESOLVED |
| IMA402 and chemotherapy +/- monoclonal antibody | Drug | — | UNRESOLVED |
| IMA402 and IMA401 | Drug | — | UNRESOLVED |
| IMA402 and monoclonal antibody | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Dose escalation/de-escalation (Phase Ia)
- description
- Dose-Finding of IMA402 as monotherapy or in combination with checkpoint inhibitor (Phase Ia)
- interventionNames
- Drug: IMA402
- Drug: IMA402 and checkpoint inhibitor
- type
- EXPERIMENTAL
- label
- Dose extension (Phase Ib)
- description
- Extension cohorts of IMA402 as monotherapy or in combination based on maximum tolerated dose (MTD) and/or recommended doses for extensions (RDEs) (Phase Ib)
- interventionNames
- Drug: IMA402
- Drug: IMA402 and checkpoint inhibitor
- Drug: IMA402 and chemotherapy
- Drug: IMA402 and IMA401
- Drug: IMA402 and monoclonal antibody
- Drug: IMA402 and chemotherapy +/- monoclonal antibody
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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 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
References
Publications (0)
Data not yet available