Refractory CancerPhase 1/2NCT05958121
IMA402 T Cell-Engaging Receptor Molecule (TCER®) in Recurrent and/or Refractory Solid Tumors
A Phase 1/2 study testing IMA402, IMA402 and checkpoint inhibitor and IMA402 and chemotherapy in people with Refractory Cancer and Recurrent Cancer, run by Immatics Biotechnologies GmbH at 29 sites in 2 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Refractory Cancer, Recurrent Cancer, Solid Tumor, Adult
- What is being tested?
- IMA402, IMA402 and checkpoint inhibitor and IMA402 and chemotherapy
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 29 sitesin 2 countries
- Study dates
- 9 Aug 2023to Sep 2027
- Phase
- Phase 1/2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
29 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
29 sites in 2 countries
Germany25 sites, 23 recruiting
- Recruiting
Universitaetsklinikum Bonn AöR
Bonn, North Rhine-Westphalia, 53127
- Recruiting
Elbe Kliniken Stade- Buxtehude Elbe Klinikum Buxtehude gGmbH
Buxtehude, Lower Saxony, 21614
- Completed
Klinikum Chemnitz gGmbH
Chemnitz, Saxony, 09116
- Recruiting
Universitaetsklinikum Carl Gustav Carus Dresden an der Technischen Universitaet Dresden AöR
Dresden, Saxony, 01307
- Recruiting
Marien Hospital Duesseldorf GmbH
Düsseldorf, North Rhine-Westphalia, 40479
- Recruiting
Universitaetsklinikum Erlangen AöR
Erlangen, Bavaria, 91054
- Recruiting
KEM I Evang. Kliniken Essen-Mitte gGmbH
Essen, North Rhine-Westphalia, 45136
- Recruiting
Universitaetsklinikum Essen AöR
Essen, North Rhine-Westphalia, 45147
- Recruiting
Goethe University Frankfurt
Frankfurt am Main, Hesse, 60590
- Recruiting
Justus-Liebig-Universitaet Giessen
Giessen, Hesse, 35392
- Not yet recruiting
Universitaetsmedizin Goettingen
Göttingen, Lower Saxony, 37075
- Recruiting
Universitaetsklinikum Heidelberg AöR
Heidelberg, Baden-Wurttemberg, 69120
- Recruiting
Thoraxklinik Heidelberg gGmbH
Heidelberg, Baden-Wurttemberg, 69126
- Recruiting
University Of Leipzig
Leipzig, Saxony, 04103
- Recruiting
Universitaetsklinikum Magdeburg AöR
Magdeburg, Saxony-Anhalt, 39120
- Recruiting
Universitaetsklinikum Mannheim GmbH
Mannheim, Baden-Wurttemberg, 68167
- Recruiting
Philipps-Universitaet Marburg
Marburg, Hesse, 35043
- Recruiting
Johannes Wesling Klinikum Minden
Minden, North Rhine-Westphalia, 32429
- Not yet recruiting
Universitaet Muenster
Münster, North Rhine-Westphalia, 48149
- Completed
Klinikum Nürnberg
Nuremberg, Bavaria, 90419
- Not yet recruiting
Sana Klinikum Offenbach GmbH
Offenbach, Hesse, 63069
- Recruiting
Universitaetsklinikum Regensburg
Regensburg, Bavaria, 93053
- Recruiting
Universitaetsklinikum Tuebingen AöR
Tübingen, Baden-Wurttemberg, 72076
- Recruiting
Universitaetsklinikum Ulm AöR
Ulm, Baden-Wurttemberg, 89081
- Recruiting
Universitaetsklinikum Wuerzburg AöR
Würzburg, Bavaria, 97080
Netherlands4 sites, 4 recruiting
- Recruiting
Antoni von Leeuwenhoek- Netherlands Cancer Institute
Amsterdam, North Holland, 1066 CX
- Recruiting
Universitair Medisch Centrum Groningen
Groningen, 9713 GZ
- Recruiting
Leiden Universitair Medisch Centrum
Leiden, South Holland, 2333 ZA
- Recruiting
Universitair Medisch Centrum Utrecht
Utrecht, 3584 CX
About this study
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
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:
Read more
- 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)
Read the 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)
- Conditions
- Refractory Cancer, Recurrent Cancer, Solid Tumor, Adult, Cancer
- Being tested
- IMA402, IMA402 and checkpoint inhibitor, IMA402 and chemotherapy, IMA402 and IMA401, IMA402 and monoclonal antibody
- Medical subject headings
- Neoplasms, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IMA402Drug
IV infusions
IMA402 and checkpoint inhibitorDrug
IMA402 IV infusions and checkpoint inhibitor
IMA402 and chemotherapyDrug
IMA402 IV infusions and chemotherapy
IMA402 and IMA401Drug
IMA402 and IMA401 IV infusions
IMA402 and monoclonal antibodyDrug
IMA402 IV infusions and monoclonal antibody
IMA402 and chemotherapy +/- monoclonal antibodyDrug
IMA402 IV infusions and chemotherapy +/- monoclonal antibody
| Study group | Role | What they receive |
|---|---|---|
| Dose escalation/de-escalation (Phase Ia) | Experimental | Dose-Finding of IMA402 as monotherapy or in combination with checkpoint inhibitor (Phase Ia) Receives: Drug: IMA402; Drug: IMA402 and checkpoint inhibitor |
| Dose extension (Phase Ib) | Experimental | Extension cohorts of IMA402 as monotherapy or in combination based on maximum tolerated dose (MTD) and/or recommended doses for extensions (RDEs) (Phase Ib) Receives: 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 |
| Dose extension (Phase II) | Experimental | Selected ISEC investigated on MTD/RDEs based on a manageable/favorable safety profile and initial signs of anti-tumor activity (Phase II) Receives: Drug: IMA402; Drug: IMA402 and checkpoint inhibitor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Phase I: Number of patients with dose limiting toxicities (DLTs)
Measured: 24 months
Phase I/II: Number of patients with treatment-emergent adverse events (TEAEs)
Measured: 40 months
Phase I/II: Number of patients with serious TEAEs
Measured: 40 months
Phase I/II: Frequency of dose interruptions and reductions, permanent discontinuations
Measured: 40 months
Phase I/II: Duration of dose interruptions and reductions, permanent discontinuations
Measured: 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)
Measured: 40 months
Secondary outcomes (10)
Phase I: ORR based on BOR of CR and PR locally assessed using RECIST v1.1 and iRECIST
Measured: 37 months
Phase II: ORR based on BOR of CR and PR locally assessed using iRECIST
Measured: 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
Measured: 40 months
Phase I/II: Duration of response (DOR) of CR or PR based on RECIST v1.1 and iRECIST
Measured: 40 months
Phase I/II: Progression-free survival (PFS) based on RECIST v1.1 and iRECIST
Measured: 40 months
Phase I/II: Overall survival (OS)
Measured: 40 months
Phase I/II: Determination of PK parameter: half-life (t1/2)
Measured: 40 months
Phase I/II: Determination of PK parameter: minimal serum concentration (Cmin)
Measured: 40 months
Phase I/II: Determination of PK parameter: maximal serum concentration (Cmax)
Measured: 40 months
Phase I/II: Determination of PK parameter: area under the curve (AUC)
Measured: 40 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2023
- Study start9 Aug 2023
- Primary completionSep 2027 (estimated)
- Study completionSep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Refractory CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Immatics Biotechnologies GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Immatics Biotechnologies GmbH, Study director, Immatics Biotechnologies GmbH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05958121
- Sponsor's protocol ID
- IMA402-101
- Other IDs
- 2022-503133-54-00
- Status last verified
- Aug 2026
- First submitted
- 14 Jul 2023
- Last updated
- 1 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is not a plan to make IPD available.