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IMA402 T Cell-Engaging Receptor Molecule (TCER®) in Recurrent and/or Refractory Solid Tumors

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05958121
Recruitment Status : Recruiting
First Posted : July 24, 2023
Last Update Posted : March 26, 2024
Sponsor:
Information provided by (Responsible Party):
Immatics Biotechnologies GmbH

Study Description
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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)

Condition or disease Intervention/treatment Phase
Refractory Cancer Recurrent Cancer Solid Tumor, Adult Cancer Biological: IMA402 (Phase Ia) Biological: IMA402 (Phase Ib) Biological: IMA402 (Phase II) Phase 1 Phase 2

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)
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 145 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I/II First-In-Human Clinical Trial to Evaluate the Safety, Tolerability and Anti-Tumor Activity of IMA402, a Bispecific TCER® Targeting PRAME, in Patients With Recurrent and/or Refractory Solid Tumors
Actual Study Start Date : August 9, 2023
Estimated Primary Completion Date : September 2027
Estimated Study Completion Date : September 2027
Arms and Interventions
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Arm Intervention/treatment
Experimental: Dose escalation/de-escalation (Phase Ia)
Dose-Finding of IMA402 (Phase Ia)
 Biological: IMA402 (Phase Ia)
Intravenous infusions in escalating dose levels
Experimental: Dose extension (Phase Ib)
IMA402 monotherapy extension cohorts based on maximum tolerated dose (MTD) and/or recommended doses for extensions (RDEs) (Phase Ib)
 Biological: IMA402 (Phase Ib)
Treatment at MTD and/or RDE (Phase Ib)
Experimental: Dose extension (Phase II)
Selected ISEC investigated on MTD/RDEs based on a manageable/favorable safety profile and initial signs of anti-tumor activity (Phase II)
 Biological: IMA402 (Phase II)
Treatment at MTD/RDE based on a manageable/favorable safety profile and initial signs of anti-tumor activity of selected ISEC (Phase II)


Outcome Measures
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Primary Outcome Measures :
  1. Phase I: Number of patients with dose limiting toxicities (DLTs) [ Time Frame: 24 months ]
  2. Phase I/II: Number of patients with treatment-emergent adverse events (TEAEs) [ Time Frame: 40 months ]
  3. Phase I/II: Number of patients with serious TEAEs [ Time Frame: 40 months ]
  4. Phase I/II: Frequency of dose interruptions and reductions, permanent discontinuations [ Time Frame: 40 months ]
  5. Phase I/II: Duration of dose interruptions and reductions, permanent discontinuations [ Time Frame: 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) [ Time Frame: 40 months ]

Secondary Outcome Measures :
  1. Phase I: ORR based on BOR of CR and PR locally assessed using RECIST v1.1 and iRECIST [ Time Frame: 37 months ]
  2. Phase II: ORR based on BOR of CR and PR locally assessed using iRECIST [ Time Frame: 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 [ Time Frame: 40 months ]
  4. Phase I/II: Duration of response (DOR) of CR or PR based on RECIST v1.1 and iRECIST [ Time Frame: 40 months ]
  5. Phase I/II: Progression-free survival (PFS) based on RECIST v1.1 and iRECIST [ Time Frame: 40 months ]
  6. Phase I/II: Overall survival (OS) [ Time Frame: 40 months ]
  7. Phase I/II: Determination of PK parameter: half-life (t1/2) [ Time Frame: 40 months ]
  8. Phase I/II: Determination of PK parameter: minimal serum concentration (Cmin) [ Time Frame: 40 months ]
  9. Phase I/II: Determination of PK parameter: maximal serum concentration (Cmax) [ Time Frame: 40 months ]
  10. Phase I/II: Determination of PK parameter: area under the curve (AUC) [ Time Frame: 40 months ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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 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

Exclusion Criteria:

  • 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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05958121


Contacts
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Contact: Immatics Biotechnologies GmbH Please E-Mail Ctgovinquiries@immatics.com

Locations
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Germany
Universitaetsklinikum Heidelberg AöR Recruiting
Heidelberg, Baden-Wuerttemberg, Germany, 69120
Universitaetsklinikum Ulm AöR Recruiting
Ulm, Baden-Wuerttemberg, Germany, 89081
Universitatsklinikum Erlangen AöR Recruiting
Erlangen, Bavaria, Germany, 91054
Universitaetsklinikum Regensburg Recruiting
Regensburg, Bavaria, Germany, 93053
Universitatsklinikum Wuerzburg AöR Recruiting
Wuerzburg, Bavaria, Germany, 97080
Universitaetsklinikum Bonn AöR Not yet recruiting
Bonn, North Rhine-Westphalia, Germany, 53127
Marien Hospital Duesseldorf GmbH Recruiting
Duesseldorf, North Rhine-Westphalia, Germany, 40479
Universitaetsklinikum Essen AöR Recruiting
Essen, North Rhine-Westphalia, Germany, 45147
Johannes Wesling Klinikum Minden Recruiting
Minden, North Rhine-Westphalia, Germany, 32429
Universitaetsklinikum Magdeburg AöR Not yet recruiting
Magdeburg, Saxony-Anhalt, Germany, 39120
Klinikum Chemnitz gGmbH Recruiting
Chemnitz, Saxony, Germany, 09116
Universitaetsklinikum Carl Gustav Carus Dresden an der Technischen Universitaet Dresden AöR Recruiting
Dresden, Saxony, Germany, 01307
University Of Leipzig Recruiting
Leipzig, Saxony, Germany, 04103
Sponsors and Collaborators
Immatics Biotechnologies GmbH
Investigators
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Study Director: Immatics Biotechnologies GmbH Immatics Biotechnologies GmbH
More Information
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Additional Information:

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Responsible Party: Immatics Biotechnologies GmbH
ClinicalTrials.gov Identifier: NCT05958121    
Other Study ID Numbers: IMA402-101
2022-503133-54-00 ( Other Identifier: Clinical Trials Information System )
First Posted: July 24, 2023    Key Record Dates
Last Update Posted: March 26, 2024
Last Verified: March 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: There is not a plan to make IPD available.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Recurrence
Disease Attributes
Pathologic Processes