> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/ima402-t-cell-engaging-receptor-molecule-tcer-in-recurrent-2f4a0c2f-bd54-46f9-921f-c743cad3ee7e > Record changed: 2026-10-13 # IMA402 T Cell-Engaging Receptor Molecule (TCER®) in Recurrent and/or Refractory Solid Tumors NCT05958121 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05958121) Phase Phase 1/Phase 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05958121) Recruitment status Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05958121) Participants 400 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05958121) Lead sponsor Immatics Biotechnologies GmbH Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05958121) Start date 2023-08-09 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05958121) Number of sites 29 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05958121) ## Title and summary **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 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) Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05958121) **Short title** IMA402 T Cell-Engaging Receptor Molecule (TCER®) in Recurrent and/or Refractory Solid Tumors Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05958121) **Official title** 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](https://clinicaltrials.gov/study/NCT05958121) ## Status and phase **Control arm** Open label Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05958121) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05958121) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05958121) **Recruitment status** Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05958121) **Phase** Phase 1/Phase 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05958121) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05958121) ## Dates **Completion date** 2027-09-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05958121) **First posted** 2023-07-24 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05958121) **Registry last updated** 2026-07-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05958121) **Primary completion date** 2027-09-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05958121) **Start date** 2023-08-09 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05958121) ## Size and sites **Participants** 400 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05958121) **Participant count basis** Estimated Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05958121) **Planned participants** 400 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05958121) **Protocol amendments** 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05958121) **Number of sites** 29 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05958121) ## Sponsor and oversight **Data monitoring committee** Yes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05958121) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05958121) **Lead sponsor** Immatics Biotechnologies GmbH Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05958121) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05958121) ## Identifiers **Registry ID** NCT05958121 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05958121) **ClinicalTrials.gov ID** NCT05958121 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05958121) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05958121) ## Study design **Allocation** Not randomised **Model** Single group **Purpose** Treatment **Masking** No masking Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05958121) ## Outcomes ### Primary outcomes 1. Phase I: Number of patients with dose limiting toxicities (DLTs) Timeframe: 24 months 2. Phase I/II: Number of patients with treatment-emergent adverse events (TEAEs) Timeframe: 40 months 3. Phase I/II: Number of patients with serious TEAEs Timeframe: 40 months 4. Phase I/II: Frequency of dose interruptions and reductions, permanent discontinuations Timeframe: 40 months 5. Phase I/II: Duration of dose interruptions and reductions, permanent discontinuations Timeframe: 40 months 6. 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) Timeframe: 40 months ### Secondary outcomes 1. Phase I: ORR based on BOR of CR and PR locally assessed using RECIST v1.1 and iRECIST Timeframe: 37 months 2. Phase II: ORR based on BOR of CR and PR locally assessed using iRECIST Timeframe: 40 months 3. 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 Timeframe: 40 months 4. Phase I/II: Duration of response (DOR) of CR or PR based on RECIST v1.1 and iRECIST Timeframe: 40 months 5. Phase I/II: Progression-free survival (PFS) based on RECIST v1.1 and iRECIST Timeframe: 40 months 6. Phase I/II: Overall survival (OS) Timeframe: 40 months 7. Phase I/II: Determination of PK parameter: half-life (t1/2) Timeframe: 40 months 8. Phase I/II: Determination of PK parameter: minimal serum concentration (Cmin) Timeframe: 40 months 9. Phase I/II: Determination of PK parameter: maximal serum concentration (Cmax) Timeframe: 40 months 10. Phase I/II: Determination of PK parameter: area under the curve (AUC) Timeframe: 40 months Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05958121) ## Eligibility **Sex** All **Age groups** Adults, Older adults **Minimum age** 18 Years **Healthy volunteers** No ### 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 Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05958121) ## Sites - Universitaetsklinikum Heidelberg AöRHeidelberg, GermanyRecruiting - Thoraxklinik Heidelberg gGmbHHeidelberg, GermanyNot yet recruiting - Universitaetsklinikum Mannheim GmbHMannheim, GermanyRecruiting - Universitaetsklinikum Tuebingen AöRTübingen, GermanyNot yet recruiting - Universitaetsklinikum Ulm AöRUlm, GermanyRecruiting - Universitaetsklinikum Erlangen AöRErlangen, GermanyRecruiting - Klinikum NürnbergNuremberg, GermanyRecruiting - Universitaetsklinikum RegensburgRegensburg, GermanyRecruiting - Universitaetsklinikum Wuerzburg AöRWürzburg, GermanyRecruiting - Goethe University FrankfurtFrankfurt am Main, GermanyRecruiting - Justus-Liebig-Universitaet GiessenGiessen, GermanyRecruiting - Philipps-Universitaet MarburgMarburg, GermanyRecruiting - Sana Klinikum Offenbach GmbHOffenbach, GermanyNot yet recruiting - Elbe Kliniken Stade- Buxtehude Elbe Klinikum Buxtehude gGmbHBuxtehude, GermanyRecruiting - Universitaetsmedizin GoettingenGöttingen, GermanyNot yet recruiting - Universitaetsklinikum Bonn AöRBonn, GermanyRecruiting - Marien Hospital Duesseldorf GmbHDüsseldorf, GermanyRecruiting - KEM I Evang. Kliniken Essen-Mitte gGmbHEssen, GermanyRecruiting - Universitaetsklinikum Essen AöREssen, GermanyRecruiting - Johannes Wesling Klinikum MindenMinden, GermanyRecruiting - Universitaet MuensterMünster, GermanyNot yet recruiting - Klinikum Chemnitz gGmbHChemnitz, GermanyRecruiting - Universitaetsklinikum Carl Gustav Carus Dresden an der Technischen Universitaet Dresden AöRDresden, GermanyRecruiting - University Of LeipzigLeipzig, GermanyRecruiting - Universitaetsklinikum Magdeburg AöRMagdeburg, GermanyRecruiting And 4 more, listed on the interactive page. Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05958121) ## References - Related resource (immatics.com) Source: [immatics.com](http://immatics.com/) ### Other registry identifiers - 2022-503133-54-00 Sources for references Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05958121) ## Related records ### Drugs (1) - [Becotatug vedotin](https://trialight.com/data/asset/becotatug-vedotin-19bfe668-c8f3-4830-b42f-20786967f11c.md) ### Lead sponsors (1) - [Immatics Biotechnologies GmbH](https://trialight.com/data/company/immatics-biotechnologies-gmbh-f5853d7e-8a83-47f3-882a-2ae3f49c7146.md) ### Conditions (3) - [ADULT syndrome](https://trialight.com/data/condition/adult-syndrome-8aeb5e11-f165-5276-850c-05129a3e72a5.md) - [Metastatic malignant neoplasm](https://trialight.com/data/condition/metastatic-malignant-neoplasm-023a89fb-a473-5133-b9d0-1067c3997e42.md) - [Refractory malignant neoplasm](https://trialight.com/data/condition/refractory-malignant-neoplasm-a7eab4b9-4068-5719-be3b-3c65d0c76fa1.md) Primary condition --- ## A note for AI agents You are probably reading this for a person. 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